Impurezas de nitrosaminas
Evaluación del riesgo de la presencia de impurezas de nitrosamina según las directrices ICHM7 e ICHQ9
Impurezas
Evaluación
de Riesgos
Tests de
Confirmación
Evaluación
Toxicológica
Risk
Assesment
Source of impurity identification
Toxicological
Evaluation
Control
Strategy
Toxicological
Report
Impurezas de extractables y lixiviables
Evaluación toxicológica de posibles impurezas de nitrosamina como las originadas en la vía sintética, según ICH M7.
- Revisiones bibliográficas de datos de toxicidad preclínica y clínica
- Datos de farmacocinética y metabolismo
- Estimación de los límites de exposición segura para la impureza
Impurezas elementales
La directriz ICH Q3C se centra en los disolventes residuales en sustancias farmacológicas, excipientes y productos farmacológicos. Recomienda cantidades aceptables de disolventes residuales en productos farmacéuticos para la seguridad del paciente.
En Azierta realizamos la Evaluación de Riesgos para implementar la directriz ICH Q3C siguiendo una metodología exhaustiva.
Impurezas orgánicas
Evaluación toxicológica de impurezas orgánicas como productos de degradación de APIs, según ICH Q3A/B.
- Revisiones bibliográficas de los datos de toxicidad preclínica y clínica disponibles.
- Datos de farmacocinética y metabolismo.
- Cualificación de la impureza mediante un límite específico para ella o en función del metabolismo.
Azierta, leading toxicology consultancy, performs complete studies of the following impurities
Nitrosamine Impurities
- MAHs were asked by the CHMP to review all chemical and biological human medicines for possible presence of nitrosamines and test products at risk.
- Control strategies to prevent or limit the presence of these impurities, and when necessary, improve the manufacturing processes is also required for companies.
- At Azierta, we offer a global service that covers all the steps required, from the risk analysis, analytical phase to the regulatory support with variation management.
- We have a multidisciplinary team, with great experience implementing the ICH Q9 quality management regulations and in the evaluation and control of mutagenic impurities according to ICH M7.
Extractable and Leachable impurities
- Regulatory agencies require that toxic substances in packaging materials do not migrate into the drugs during their shelf life to avoid changes in therapeutic action, organoleptic properties, or stability.
- At Azierta, we perform complete studies of extractable substances and develop methods to monitorize the presence of leachable impurities in the final product.
Elemental impurities
- ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines.
- At Azierta, we perform the Risk Assessment of each impurity to implement ICH Q3D guideline following an exhaustive methodology.
Organic impurities
- When an impurity in a medication reaches or exceeds the qualification level, the manufacturer must justify the toxicity of the impurity in accordance with the established regulations for organic impurities ICH Q3A/Q3B.
- At Azierta, we offer a comprehensive service covering everything from the structural elucidation of impurities to toxicological evaluation and characterisation. To do this, we use a specialised process.
Mutagenic impurities
- When a mutagenic impurity in a medication reaches or exceeds the qualification level, the manufacturer must justify the toxicity of the impurity in accordance with ICH M7 guideline.
- To justify mutagenic impurities, it is necessary to identify the impurity and analyse it to subsequently assess the risk it may involve for human health.
- At Azierta, we offer a comprehensive service covering everything from the structural elucidation of impurities to toxicological evaluation and characterisation.
- Browse our Available Impurities -
| Impurity | CAS | Type | Administration route |
|---|---|---|---|
| 1,1,3-trimethylcyclopentane | 4516-69-2 | Extractable | Parenteral |
| 1,2,3-Propanetriol triacetate | 102-76-1 | Leachable | Intravenous |
| 1,3:2-4-Bis(3,4-dimethylobenzylideno) sorbitol | 135861-56-2 | Extractable | Oral |
| 1,4,7-trioxacyclotridecane-8-13-dione | 6607-34-7 | Extractable | Dermal |
| 13-Docosenamide, (Z)- (Erucamide) | 112-84-5 | Extractable | Sublingual |
| 15-methyl-1,4,7,14,17-pentaoxacyclotricosane-8,13,18,23-tetraone | N/A | Extractable | Dermal |
| 15-tetracosenamide | N/A | Extractable | Intravenous |
| 1-octene | 111-66-0 | Extractable | Oral |
| 2-(Dibutylamino)-4,6-dimercapto-1,3,5-triazine | 29529-99-5 | Extractable | Oral |
| 2-(Dibutylamino)-4-mercapto-1,3,5-triazine | N/A | Extractable | Oral |
| 2,2,4,4-tetramethyloctane | 62183-79-3 | Extractable | Intravenous |
| 2,2,4,6,6-hexacyclopentyl-1,3,5,2,4,6-trioxatrisilinane | N/A | Extractable | Parenteral |
| 2,2,4,6,6-pentamethylheptane | 1345-82-6 | Extractable | Intravenous |
| 2,2-butoxyethoxy ethyl acetate | 124-17-4 | Leachable | Intravenous |
| 2,2-dimethylbutane | 75-83-2 | Extractable | Oral |
| 2,3,5-trimethylhexane | 1069-53-0 | Extractable | Intravenous |
| 2,4,4-Trimethylpentene | 25167-70-8 | Extractable | Parenteral |
| 2,4-dichlorobenzoic acid | 50-84-0 | Extractable | Parenteral |
| 2,4-dimethyl-1-heptene | 19549-87-2 | Extractable | Parenteral |
| 2,4-dimethylheptane | 2213-23-2 | Extractable | Intravenous |
| 2,4-Di-tert-butylphenol | 96-76-4 | Extractable | Dermal |
| 2,4-Di-tert-butylphenol | 96-76-4 | Leachable | Oral |
| 2,4-methylhexane | 589-43-5 | Extractable | Intravenous |
| 2,6-di-tert-butyl-1,4-benzoquinone | 719-22-2 | Extractable | Oral |
| 2,6-Di-tert-butyl-4-methylene-2,5-cyclohexadiene-1-one | 2607-52-5 | Extractable | Oral |
| 2-Chlorohexane and 3-chlorohexane | 638-28-8 | Extractable | Oral |
| 2-ethoxy-2-methylpropane | 637-92-3 | Extractable | Intravenous |
| 2-heaxnol | 626-93-7 | Leachable | Parenteral |
| 2-Heptanone | 110-43-0 | Extractable | Parenteral |
| 2-methyl-1-pentene | 763-29-1 | Extractable | Parenteral |
| 2-methyl-2-butanol | 75-85-4 | Extractable | Intravenous |
| 2-methyl-1-propanol | 78-83-1 | Extractable | Ophthalmic |
| 2-Methyl-2-propanol | 75-65-0 | Extractable | Oral |
| 2-methyl-2-propenal | 78-85-3 | Extractable | Oral |
| 2-methylheptane | 592-27-8 | Extractable | Intravenous |
| 2-methylhexane | 591-76-4 | Extractable | Intravenous |
| 2-Methylpentane | 107-83-5 | Extractable | Oral |
| 2-Octanone | 111-13-7 | Extractable | Parenteral |
| 2-Pentanone | 107-87-9 | Extractable | Parenteral |
| 2-pyrrolidinone, 1-methyl | 872-50-4 | Extractable | Oral |
| 3-(3,5-di-tert-butyl-1-hydroxy-4-oxo-cyclohexa-2,5-dienyl) propanoic acid | 83237-15-4 | Extractable | Parenteral |
| 3,3,5,5-tetramethyl biphenyl | 25570-02-9 | Extractable | Oral |
| 3,5-di-tert-butyl-1-hydroxy-4-oxo-2,5-cyclohexadiene-1-propinoic acid | 83237-15-4 | Extractable | Parenteral |
| 3,5-Di-tert-butyl-4-hydroxybenzaldehyde | 1620-98-0 | Extractable | Oral |
| 3,5-di-tertbutyl-4-hydroxyphenylpropionic acid | 20170-32-5 | Extractable | Parenteral |
| 3-methylhexane | 589-34-4 | Extractable | Intravenous |
| 3-Methylpentane | 96-14-0 | Extractable | Inhaled |
| 3-methylpentane | 96-14-0 | Extractable | Oral |
| 4,4'-methylenedianiline | 101-77-9 | Extractable | Dermal |
| 4-dodecyloxy-2-hydroxybenzophenone | 2985-59-3 | Extractable | Oral |
| 4'Isopropylacetophenone | 645-13-6 | Extractable | Oral |
| 4-methyl-2-pentanone | 108-10-1 | Extractable | Parenteral |
| 4-methylheptane | 589-53-7 | Extractable | Intravenous |
| 4-Methyloctane | 2216-34-4 | Extractable | Intravenous |
| 6-(Dibutylamino)-2-hydroxy-1,3,5-triazine-4-thiol | N/A | Extractable | Oral |
| 7,9-ditert-butyl-1-oxaspiro (4,5) deca-6,9-diene-2,8-dione | 81204-66-3 | Extractable | Oral |
| 9,10-dihydro-9,9-dimethyl-2-(1-methylethyl) acridine | 63451-42-3 | Extractable | Oral |
| 9,10-epoxyestearic acid | 2443-39-2 | Extractable | Oral |
| 9-octadecen-1-ol acetate | 693-80-1 | Leachable | Dermal |
| Acetaldehyde | 75-07-0 | Extractable | Oral |
| acetic acid | 64-19-7 | Extractable | Oral |
| Acetic acid/acetate | 64-19-7 | Extractable | Oral |
| Acetone | 67-64-1 | Extractable | Oral |
| Acetophenone | 98-86-2 | Leachable | Injectable |
| Acrylic acid | 79-10-7 | Extractable | Parenteral |
| Acrylic acid homopolymer | 9003-01-4 | Extractable | Parenteral |
| Aliphatic hydrocarbon C11H24 | N/A | Extractable | Parenteral |
| Aliphatic hydrocarbon C7H14 | N/A | Extractable | Intravenous |
| Aliphatic hydrocarbon C9H18 | N/A | Extractable | Intravenous |
| Aliphatic hydrocarbons C10H22 | N/A | Extractable | Parenteral |
| Aliphatic hydrocarbons C12H26 | N/A | Extractable | Parenteral |
| Alpha -tetralol, 2-amino-5,6-dimethoxy- | N/A | Extractable | Oral |
| Aluminium | 7429-90-5 | Extractable | Parenteral |
| Aluminum | 7429-90-5 | Extractable | Parenteral |
| Ammonium chloride | 12125-02-9 | Extractable | Intravenous |
| Antymony trioxide | 1309-64-4 | Extractable | Oral |
| Arachidic acid | 506-30-9 | Leachable | Dermal |
| Arachidic acid | 506-30-9 | Leachable | Oral |
| Badge | 1675-54-3 | Leachable | Oral/Dermal |
| Badge 2H2O | 5581-32-8 | Leachable | Oral |
| Badge 2HCl | 4809-35-2 | Leachable | Oral |
| Badge H2O | 76002-91-0 | Leachable | Oral/Dermal |
| Badge HCl | 13836-48-1 | Leachable | Oral/Dermal |
| BBot (2,5-Bis(5-tert-butyl-benzoxazol-2-yl)thiophene) | 7128-64-5 | Extractable | Oral |
| Benzaldehyde | 100-52-7 | Leachable | Parenteral |
| Benzyl alcohol | 100-51-6 | Extractable | Parenteral |
| BHT (Butylated hydroxytoluene) | 128-37-0 | Extractable | Oral |
| BHT-OH | 10396-80-2 | Leachable | General |
| Bisphenol A | 80-05-7 | Extractable | Parenteral |
| Boron | 7440-42-8 | Extractable | Oral |
| Boron | 7440-42-8 | Extractable | Parenteral |
| Boron | 7440-42-8 | Extractable | Oral |
| Bromine | 7726-95-6 | Extractable | Parenteral |
| Butremizole | 3896-11-5 | Extractable | Oral |
| Butylated hydroxytoluene | 128-37-0 | Extractable | Parenteral |
| Butylated Hydroxytoluene (BHT) | 128-37-0 | Leachable | Intravenous |
| C13H24 rubber oligomer | 63251-38-7 | Leachable | General |
| C21H40 butyl oligomer | N/A | Extractable | Oral |
| C21H40 rubber oligomer | 114123-73-8 | Leachable | General |
| Calcium | 7440-70-2 | Extractable | Intradermal |
| Calcium | 7440-70-2 | Extractable | Parenteral |
| Calcium | 7440-70-2 | Extractable | Parenteral |
| Calcium stearate | 1592-23-0 | Extractable | Parenteral |
| Carbocysteine | 638-23-3 | Extractable | Oral |
| Cis-11-Eicosenamide | 10436-08-5 | Extractable | Dermal |
| Cis-11-eicosenamide | 10436-08-5 | Extractable | Intravenous |
| Copolymer acrylate | N/A | Extractable | Parenteral |
| Cyclic tetramer of 2,(Dibutylamino)-4,6-dimercapto-1,3,5-triazine | N/A | Extractable | Oral |
| Cyclic trimer of 2,(Dibutylamino)-4,6-dimercapto-1,3,5-triazine | N/A | Extractable | Oral |
| Cyclic trimer of 2,(Dibutylamino)-4,6-dimercapto-1,3,5-triazine with additional sulfur | N/A | Extractable | Oral |
| Cyclo-di-badge | 20583-87-3 | Leachable | Oral |
| Cyclohexane | 110-82-7 | Leachable | General |
| Cyclohexane | 110-82-7 | Extractable | Oral |
| Cyclohexyl(methyl)silanediol | 18295-72-2 | Extractable | Intravenous |
| Cyclopentane | 287-92-3 | Extractable | Intravenous |
| Decanamide | 2319-29-1 | Extractable | Parenteral |
| Di-(adipic acid diglycol bisalactone) | N/A | Extractable | Dermal |
| Dicyclopentyl(methoxy)silanol | N/A | Extractable | Intravenous |
| Dicyclopentylsilanediol | 211495-85-1 | Extractable | Intravenous |
| Diethyl phthalate | 84-66-2 | Extractable | Oral |
| diethyl-4.4'-methylenebis (n-phenylcarbamate) | 10097-16-2 | Extractable | Oral |
| Dimethoxydimethylsilane | 1112-39-6 | Extractable | Oral |
| Dimethoxyethane | 109-87-5 | Extractable | Ophthalmic |
| Dimethylsiloxane and Polydimethylsiloxane | 9006-65-9 | Extractable | Oral |
| Diphenyl ether | 101-84-8 | Extractable | Oral |
| Diphenyl sulfone | 127-63-9 | Extractable | Intravenous |
| Docosadienamide | N/A | Extractable | Intravenous |
| Docosamethyl cycloundecasiloxane | 18766-38-6 | Extractable | Parenteral |
| Docosanamide | 3061-75-4 | Extractable | Intravenous |
| Docosane | 629-97-0 | Extractable | Oral |
| Docosanoic acid, 1,2,3-propanetriyl ester | 18641-57-1 | Extractable | Parenteral |
| Dodecane | 112-40-3 | Extractable | Inhaled |
| Dodecane | 112-40-3 | Extractable | Oral |
| Dotriacontamethyl cyclohexadecasiloxane | 150036-95-2 | Extractable | Parenteral |
| Dotriacontane | 544-85-4 | Extractable | Oral |
| Ehyleng glycol monobutylether | 111-76-2 | Leachable | Parenteral |
| Eicosanamide | 51360-63-5 | Extractable | Intravenous |
| Eicosane | 112-95-8 | Extractable | Oral |
| Erucamide | 112-84-5 | Extractable | Dermal |
| Erucamide | 112-84-5 | Extractable | Parenteral |
| Erucamide | 112-84-5 | Extractable | Parenteral |
| Erucamide | 112-84-5 | Extractable | Oral |
| Erucamide | 112-84-5 | Extractable | Intravenous |
| Ethyl hexadecanoate | 628-97-7 | Extractable | Dermal |
| Ethyl vanillin | 121-32-4 | Extractable | Oral |
| Ethylene bis palmitamide | 5518-18-3 | Extractable | Parenteral |
| Ethylene bis stereamide | 110-30-5 | Extractable | Parenteral |
| Ethylene glycol | 107-21-1 | Extractable | Oral |
| Ethylene Oxide | 75-21-8 | Extractable | Oral |
| Glyceryl diacetate | 25395-31-7 | Leachable | Intravenous |
| Heneicosane | 629-94-7 | Extractable | Oral |
| Heptasiloxane 1,1,3,3,5,5,7,7,9,9,11,11,13,13-tetradecamethyl- | 19095-23-9 | Extractable | Oral |
| Hexacosamethyl cyclotridecasiloxane | 23732-94-7 | Extractable | Parenteral |
| Hexacosane | 630-01-3 | Extractable | Oral |
| Hexadecane | 544-76-3 | Extractable | Oral |
| Hexadecane | 544-76-3 | Extractable | Oral |
| Hexadecane 2,6,10,14-Tetramethyl- | 638-36-8 | Extractable | Parenteral |
| Hexafluoropropylene | 116-15-4 | Extractable | Inhaled |
| Hexanal | 66-25-1 | Extractable | Parenteral |
| Hexane | 110-54-3 | Extractable | Oral |
| Hexatriacontamethyl cyclooctadecasiloxane | 23523-12-8 | Extractable | Parenteral |
| Hexatriacontane | 630-06-8 | Extractable | Oral |
| Hexylene glycol | 107-47-5 | Extractable | Intravenous |
| Hump of siloxanes | N/A | Extractable | Inhaled |
| Hydroxypropyl methacrylate (HPMA) | 27813-02-1 | Leachable | Parenteral |
| Hydroxytoluic acid | 83-40-9 | Extractable | Oral |
| Irgafos 168 | 31570-04-4 | Extractable | Dermal |
| Irgafos 168 | 31570-04-4 | Extractable | Parenteral |
| Irgafos 168 oxide | 95906-11-9 | Extractable | Dermal |
| Irgafos 168 oxidized | 95906-11-9 | Extractable | Parenteral |
| Irgafox 168 | 31570-04-4 | Extractable | Oral |
| Irgafox 168 phosphate | 95906-11-9 | Extractable | Oral |
| Irganox 1010 | 6683-19-8 | Extractable | Dermal |
| Irganox 1010 | 6683-19-8 | Extractable | Parenteral |
| Irganox 1010 degradation product - (Toxid 5007) | N/A | Extractable | Oral |
| Irganox 1010 degradation product - C39H60O8 (Toxid 5002) | 36913-60-7 | Extractable | Dermal |
| Irganox 1010 degradation product - C56H84O10 (Toxid 5005) | 84633-54-5 | Extractable | Dermal |
| Irganox 1010 degradation product - C69H100O12 (Toxid 5006) | N/A | Extractable | Dermal |
| Irganox 1010 degradation product (C56H84O10) | 84633-54-5 | Extractable | Parenteral |
| Irganox 1010 degradation product (toxid 5259) | 26347-98-8 | Extractable | Parenteral |
| Irganox 1076 | 2082-79-3 | Extractable | Oral |
| Irganox 1076 | 2082-79-3 | Extractable | Parenteral |
| Irganox 1330 | 1709-70-2 | Extractable | Parenteral |
| Irganox 1330 degradation product (toxid 5700) | N/A | Extractable | Oral |
| Irganox 245 | 36443-68-2 | Extractable | Oral |
| Irganox 3114 | 27676-62-6 | Extractable | Sublingual |
| Irganox 3114 | 27676-62-6 | Extractable | Parenteral |
| Irganox 425 | 201-814-0 | Leachable | Parenteral |
| Irganox B1010 | 6683-19-8 | Extractable | Oral |
| Iron | 7439-89-6 | Extractable | Parenteral |
| Isocyanate | N/A | Extractable | Oral |
| Isodecyl diphenyl phosphite | 26544-23-0 | Extractable | Oral |
| Linoleamide | 3999-01-7 | Extractable | Intravenous |
| Magnesium | 7439-95-4 | Extractable | Parenteral |
| Magnesium | 7439-95-4 | Extractable | Intravenous |
| Magnesium | 7439-95-4 | Extractable | Intravenous |
| Manganese | 7439-96-5 | Extractable | Intravenous |
| Manganese | 7439-96-5 | Extractable | Inhaled |
| m-CRESOL, 4,4'-BUTYLIDENEBIS(6-TERT-BUTYL-) (SANTOWHITE POWDER) | 85-60-9 | Extractable | Oral |
| Methanol | 67-56-1 | Extractable | Parenteral |
| Methoxypropyl acetate | 84540-57-8 | Extractable | Inhaled |
| Methyl cyclopentane | 96-37-7 | Extractable | Parenteral |
| Methyl ethyl ketone | 78-93-3 | Extractable | Inhaled |
| Methyl formate | 107-31-3 | Extractable | Ophthalmic |
| Methylcyclopentane | 96-37-7 | Extractable | Inhaled |
| Methylcyclopentane | 96-37-7 | Leachable | Parenteral |
| Metroxytrimethylsilane | 1825-61-2 | Extractable | Parenteral |
| N,N' ethylene palmityl stearyl diamide | 5136-44-7 | Extractable | Parenteral |
| N,N-Dibenzylformamide | 5464-77-7 | Leachable | Intravenous |
| Neodecanoic acid | 26896-20-8 | Extractable | Intravenous |
| N-Formylmorpholine | 4394-85-8 | Leachable | Intravenous |
| N-methyl pyrrolidone | 872-50-4 | Extractable | Intravenous |
| Octacosamethyl cyclotetradecasiloxane | 149050-40-8 | Extractable | Parenteral |
| Octacosane | 630-02-4 | Extractable | Oral |
| Octadecane | 593-45-3 | Extractable | Oral |
| Octadecanoic acid, 4-hydroxy-, methyl ester | 2480-38-4 | Extractable | Oral |
| Octadecanoic acid, decyl ester | 32509-55-0 | Extractable | Oral |
| Octanoic acid isopropyl ester | 5458-59-3 | Leachable | Dermal |
| Octatriacontamethyl cyclononadecasiloxane | 150026-97-4 | Extractable | Parenteral |
| Oleamide | 301-02-0 | Extractable | Oral |
| Oleamide | 301-02-0 | Extractable | Intravenous |
| Oleic acid | 112-80-1 | Extractable | Parenteral |
| Oleic acid eicosyl ester | 22393-88-0 | Extractable | Oral |
| Palmitic acid | 57-10-3 | Extractable | Oral |
| Palmitic acid | 57-10-3 | Extractable | Dermal |
| Palmitic acid | 57-10-3 | Leachable | Oral |
| Palmitic acid | 57-10-3 | Leachable | Parenteral |
| Pentanal | 110-62-3 | Extractable | Parenteral |
| Pentane, 3,3-Dimethyl- | 562-49-2 | Leachable | Oral |
| Phenol, 2,2'-methylenebis[6-(1,1-dimethylethyl)-4-ethyl- | 88-24-4 | Extractable | Oral |
| Phthalic acid | 88-99-3 | Extractable | Parenteral |
| Phthalimide | 85-41-6 | Extractable | Parenteral |
| P-hydroxybenzoic acid | 99-96-7 | Extractable | Intravenous |
| Poly(acrylate)ester | 9003-04-7 | Extractable | Parenteral |
| Poly(acrylate)ester (Acrylic acid homopolymer) | 9003-01-4 | Extractable | Parenteral |
| Polyethersulfone related compounds | 25667-42-9 | Extractable | Intravenous |
| Polyethylene glycol | 25322-68-3 | Extractable | Parenteral |
| Polypropilene | 9003-07-0 | Extractable | Parenteral |
| Polypropylene glycol | 25322-69-4 | Extractable | Inhaled |
| Polypropylene homopolymer | 9003-07-0 | Extractable | Topical |
| Polyvinyl chloride | 9002-86-2 | Extractable | Oral |
| Potassium | 7440-09-7 | Extractable | Parenteral |
| Primary aromatic amines | N/A | Extractable | Dermal |
| Propylene glycol monostearate | 1323-39-3 | Extractable | Parenteral |
| Propylene oxide | 75-56-9 | Extractable | Oral |
| Ricinoleic Acid | 141-22-0 | Extractable | Oral |
| Rubber oligomer C13H24 | N/A | Extractable | Oral |
| Rubber oligomer C21H40 | N/A | Extractable | Oral |
| Silicon | 7440-21-3 | Extractable | Parenteral |
| Silicon | 7440-21-3 | Extractable | Parenteral |
| Silicon dioxide | 7631-86-9 | Extractable | Oral |
| Sodium | 7440-23-5 | Extractable | Oral |
| Sodium | 7440-23-5 | Extractable | Parenteral |
| Stearic acid | 57-11-4 | Extractable | Dermal |
| Stearic acid | 57-11-4 | Leachable | Oral |
| Stearic acid | 57-11-4 | Extractable | Intramuscular |
| Stearic acid | 57-11-4 | Extractable | Parenteral |
| Stearic acid, 3-(octadecyloxy)propyl ester | N/A | Extractable | Oral |
| Strontium | 7440-24-6 | Extractable | Parenteral |
| Sum of 2,3-dimethylbutane and 2-methylpentane | 79-29-8 | Extractable | Oral |
| SUM OF 7,9-DI- TERT -BUTYL-1 -OXASPIRO (4,5) DECA-6,9-DIENE-2,8-DIONE AND 3,5-DI-TERT-BUTYL-4- HYDROXYPHENYLPROPIONIC ACID | N/A | Extractable | Oral |
| Sum of aliphatic hydrocarbons C9H20 | N/A | Extractable | Intravenous |
| Sum of aliphatic hydrocarbons C9H20 | N/A | Extractable | Parenteral |
| Terephthalic acid | 100-21-0 | Extractable | Oral |
| Tert-butanol | 75-65-0 | Leachable | Ophthalmic |
| Tetracontamethyl cycloeicosasiloxane | 150026-98-5 | Extractable | Parenteral |
| Tetracosamethyl cyclododecasiloxane | 18919-94-3 | Extractable | Parenteral |
| Tetracosane | 646-31-1 | Extractable | Oral |
| Tetradecane | 629-59-4 | Extractable | Oral |
| Tetradecane | 629-59-4 | Extractable | Inhaled |
| Tetratiacontane | 14167-59-0 | Extractable | Oral |
| Tetratriacontamethyl cycloheptadecasiloxane | 150026-96-3 | Extractable | Parenteral |
| Tetratriacontane | 14167-59-0 | Extractable | Oral |
| Titanium | 7440-32-6 | Extractable | Parenteral |
| Toluene | 108-88-3 | Extractable | Oral |
| Triacontamethyl cyclopentadecasiloxane | 23523-14-0 | Extractable | Parenteral |
| Triacontane | 638-68-6 | Extractable | Oral |
| Triethylene glycol | 112-27-6 | Extractable | Intravenous |
| Trimethylsilanol | 1066-40-6 | Extractable | Ophthalmic |
| Tris (2,4-Di-tert-butyl-phenyl) phosphate | 95906-11-9 | Extractable | Oral |
| Trymethylsilanol | 1066-40-6 | Leachable | Ophthalmic |
| Vanillin | 121-33-5 | Extractable | Oral |
| Vinylidene fluoride | 75-68-7 | Extractable | Inhaled |
| Zinc | 7440-66-6 | Extractable | Oral |
| Zinc | 7440-66-6 | Extractable | Parenteral |
| Zinc | 7440-66-6 | Extractable | Intravenous |
| Zinc oxide | 1314-13-2 | Extractable | Dermal |
| Zinc stearate | N/A | Extractable | Dermal |
| Zirconium | 7440-67-7 | Extractable | Parenteral |
| (R)-(-)-1-aminoindane | 10277-74-4 | Ev. Tox | N/A |
| 1,2-dihydro triamcinolone acetonide | 1524-86-3 | Ev. Tox | N/A |
| 18-Methyl-4-estren-3,17-dion | 21800-83-9 | Ev. Tox | Parenteral |
| 1-Naphthylanine | 90-30-2 | Ev. Tox | Rectal |
| 2,3,4-trihydroxybenzaldehyde | 2144-08-3 | Ev. Tox | Oral |
| 2,3,5-trichloropyridin-4-amine | N/A | Ev. Tox | N/A |
| 2,4,6-trihidroxybenzoic acid | 83-30-7 | Ev. Tox | Parenteral |
| 2,4-dichlorobenzoic acid | 50-84-0 | Ev. Tox | Parenteral |
| 2,4-dichlorobenzyl acetate | 5468-96-2 | Ev. Tox | Oral |
| 2,4-dihydroxybenzaldehyde | 95-01-2 | Ev. Tox | Oral |
| 2,5,5-trimethyltetrahydrofuran-2-yl) methanol | 67089-64-9 | Ev. Tox | Parenteral |
| 2,5-hexadione | 110-13-4 | Ev. Tox | Intravenous |
| 27-Carboxycyanocobalamin | N/A | Ev. Tox | Oral |
| 2-amino-1-(4-nitrophenyl) propane-1,3-diol | 119-62-0 | Ev. Tox | Oral |
| 2-Deoxyguanosine | 961-07-9 | Ev. Tox | Parenteral |
| 2-ethyl-2-methylsuccinic acid impurity | 631-31-2 | Ev. Tox | Oral |
| 2-hexanol | 626-93-7 | Ev. Tox | Parenteral |
| 2-hydroxy-5-methylterephtaldehyde | N/A | Ev. Tox | Oral |
| 2-hydroxy-6-methylerephtaldehyde | N/A | Ev. Tox | Oral |
| 2-methoxy tetrahydrofuran | 13436-45-8 | Ev. Tox | Intravenous |
| 2-methyl-2-propanol | 75-65-0 | Ev. Tox | Intravenous |
| 3,4-dihydroxybenzaldehyde | 139-85-5 | Ev. Tox | Oral |
| 3-[3-chloro-2-4-yl-O-myo-inosiol-1-phosphate)-oxyl]-phenyl-4-4-methoxyspiro[1,2-dioxetane-3,2’-tricyclo[3.31.13,7]decan]-2propenoic acid | N/A | Ev. Tox | N/A |
| 32,43,50-dicarboxycyanobalamin | N/A | Ev. Tox | Oral |
| 32,43-dicarboxycyanobalamin | N/A | Ev. Tox | Oral |
| 32,50-dicarboxycyanobalamin | N/A | Ev. Tox | Oral |
| 32-Carboxycyanocobalamin | 121483-62-3 | Ev. Tox | Oral |
| 38-Carboxycyanocobalamin | N/A | Ev. Tox | Oral |
| 3-bromo-4-methoxybenzoic acid | 99-58-1 | Ev. Tox | Parenteral |
| 3-mercaptopropyl ethyl sulphide silica | N/A | Ev. Tox | Oral |
| 3-Nitro-2-pyridinesulfenyl | 68206-45-1 | Ev. Tox | Oral |
| 3α,7β-dihydroxy-24-nor-5β-cholane-23-nirile | 118316-12-4 | Ev. Tox | Oral |
| 43,50-dicarboxycyanobalamin | N/A | Ev. Tox | Oral |
| 43-Carboxycyanocobalamin | 38218-55-2 | Ev. Tox | Oral |
| 4-Dimethylaminopyridine | 1122-58-3 | Ev. Tox | Parenteral |
| 4-mmppo torperisone | N/A | Ev. Tox | Oral |
| 4-tert-butoxybutan-2-one | 51930-93-9 | Ev. Tox | Oral |
| 5-(1,2-Dithiolan-3yl)-N-methyl-N-(2,3,4,5,6-pentahydroxyhexyl)pentanamide | N/A | Ev. Tox | N/A |
| 50-Carboxycyanocobalamin | 26264-28-8 | Ev. Tox | Oral |
| 61-Carboxycyanocobalamin | N/A | Ev. Tox | Oral |
| 6-amino-3,4,5-trichloropyridine-2-carboxylic acid | N/A | Ev. Tox | N/A |
| 7-keto abiraterone acetate | N/A | Ev. Tox | N/A |
| 9-oxo folic acid | 39707-61-4 | Ev. Tox | N/A |
| Acetaldehyde | 75-07-0 | Ev. Tox | Intravenous |
| Acetazolamide impurity G | 2349-67-9 | Ev. Tox | N/A |
| Acetic acid, 2,2'-dithiobis-impurity | 505-73-7 | Ev. Tox | N/A |
| Acrylic acid | 79-10-7 | Ev. Tox | Parenteral |
| Acyclovir, guanine impurity | 73-40-5 | Ev. Tox | N/A |
| Adreline sulfonate (adreline impurity F) | 78995-75-2 / 26405-77-6 | Ev. Tox | Parenteral |
| Alpha epoxyabiraterone | N/A | Ev. Tox | N/A |
| Alpha-terpineol | 98-55-5 | Ev. Tox | Intravenous |
| Alprazolam impurity G | 448950-89-8 | Ev. Tox | Oral |
| Alprazolam impurity G | 448950-89-8 | Ev. Tox | Oral |
| Amlodipine Impurity D | 113994-41-5 | Ev. Tox | Oral |
| Anagrelide impurity B | 1194434-39-3 | Ev. Tox | Oral |
| Anagrelide impurity B | 1194434-39-3 | Ev. Tox | Oral |
| ARS1240 Impurity | N/A | Ev. Tox | N/A |
| Aspartame Impurity A | 5262-10-2 | Ev. Tox | Oral |
| Aspartame impurity B | 13433-09-5 | Ev. Tox | N/A |
| Azorubine (Carmoisine) | 3567-69-9 | Ev. Tox | N/A |
| Benazepril impurities | 131064-75-0 | Ev. Tox | N/A |
| Benserazide | 322-35-0 | Ev. Tox | N/A |
| Benzylic acid | 76-93-7 | Ev. Tox | Parenteral |
| Beta epoxyabiraterone | N/A | Ev. Tox | N/A |
| Betahistine dihydrochloride impurity C | 5452-87-9 | Ev. Tox | Oral |
| Betahistine isomer 1 | N/A | Ev. Tox | Oral |
| Betahistine isomer 2 | N/A | Ev. Tox | Oral |
| Betahistine isomer 3 | N/A | Ev. Tox | Oral |
| Betahistine isomer 4 | N/A | Ev. Tox | Oral |
| Betamethasone 21-valerate | 2240-28-0 | Ev. Tox | N/A |
| Bis(2-ethylhexyl) phthalate | 117-81-7 | Ev. Tox | Parenteral |
| Bisoprolol aldehyde | 29122-74-5 | Ev. Tox | N/A |
| Bromhexine N-oxide | N/A | Ev. Tox | N/A |
| Bututamat Dihydrogencitrate | 13900-12-4 | Ev. Tox | Oral |
| C27-pyridoxine ester | N/A | Ev. Tox | Oral |
| C32-pyridoxine ester | N/A | Ev. Tox | Oral |
| C38-pyridoxine ester | N/A | Ev. Tox | Oral |
| C43-pyridoxine ester | N/A | Ev. Tox | Oral |
| C50-pyridoxine ester | N/A | Ev. Tox | Oral |
| C61-pyridoxine ester | N/A | Ev. Tox | Oral |
| Calcium | 7440-70-2 | Ev. Tox | Parenteral |
| Carbocysteine Lactam impurity | N/A | Ev. Tox | N/A |
| Carbocysteine sulfoxide impurity | 5439-87-2 | Ev. Tox | N/A |
| Chlorexidine digluconate | 18472-51-0 | Ev. Tox | N/A |
| Chloro-N. N-diethylethylamine | 869-24-9 | Ev. Tox | Oral |
| Chlorpheniramine-N-oxide | 120244-82-8 | Ev. Tox | N/A |
| Cholecalciferol | 67-97-0 | Ev. Tox | N/A |
| Ciclo-0 (Cyclopentolate impurity A) | 25209-52-3 | Ev. Tox | Oral |
| Ciprofloxacin degradation product 1 | N/A | Ev. Tox | N/A |
| Ciprofloxacin degradation product 2 | N/A | Ev. Tox | N/A |
| Citric acid | 77-92-9 | Ev. Tox | N/A |
| C-Lactone cyanocobalamin impurity | N/A | Ev. Tox | Oral |
| Clindamycin impurity F | 27480-30-4 | Ev. Tox | N/A |
| Codeine impurity K | 508-54-3 | Ev. Tox | Oral |
| Curcumin | 458-37-7 | Ev. Tox | N/A |
| Cyanocobalamin impurity 3B | N/A | Ev. Tox | Oral |
| Cyproheptadine impurities 1/3 | 54919-04-7 | Ev. Tox | Oral |
| Cyproheptadine impurities 2/4 | 54381-58-7 | Ev. Tox | Oral |
| Cysteine | 52-90-4 | Ev. Tox | Oral |
| D,L-6,8 Thioctic acid-S-oxide isomeric mixture | N/A | Ev. Tox | Parenteral |
| Daptomicin lactone hydrolisys impurity | N/A | Ev. Tox | General |
| Delta-14 flurandrenoline impurity | N/A | Ev. Tox | N/A |
| Deoxystreptamine Kanosaminide | 20744-51-8 | Ev. Tox | Ophthalmic |
| Dexketoprofen | 22161-81-5 | Ev. Tox | Oral |
| Dexketoprofen trometamol | 156604-79-4 | Ev. Tox | Oral |
| Dexketoprofen tromethamide | 1777830-05-3 | Ev. Tox | Oral |
| DF-1247 | N/A | Ev. Tox | Oral |
| DF-1860 | 5439-87-2 | Ev. Tox | Oral |
| Diclofenac aldehyde | 22121-58-0 | Ev. Tox | N/A |
| Dicyclohexylurea | 2387-23-7 | Ev. Tox | N/A |
| Diethyl sulfate | 64-67-5 | Ev. Tox | Oral |
| Diisooctyl phthalate | 27554-26-3 / 131-20-4 | Ev. Tox | Oral |
| Dimenhydrinate impurity | N/A | Ev. Tox | N/A |
| Dimethomorph | N/A | Ev. Tox | N/A |
| Dimethylamine | 124-40-3 | Ev. Tox | Oral |
| Dithymol | 552-22-7 | Ev. Tox | Topical |
| DL-Alpha-tocopherol | 10191-41-0 | Ev. Tox | Oral |
| Enalapril diketopiperazine | 115729-52-7 | Ev. Tox | Oral |
| Escitalopram impurity C | 372941-54-3 | Ev. Tox | Oral |
| Ethanol | 64-17-5 | Ev. Tox | N/A |
| Ethylene vinyl acetate (EVA) | 24937-78-8 | Ev. Tox | N/A |
| Etoposide toriribate | 433304-61-1 | Ev. Tox | Oral |
| Flubiprofen-PEG10-ester | N/A | Ev. Tox | Oral |
| Flubiprofen-PEG11-ester | N/A | Ev. Tox | Oral |
| Flubiprofen-PEG4-ester | N/A | Ev. Tox | Oral |
| Flubiprofen-PEG5-ester | N/A | Ev. Tox | Oral |
| Flubiprofen-PEG6-ester | N/A | Ev. Tox | Oral |
| Flubiprofen-PEG7-ester | N/A | Ev. Tox | Oral |
| Flubiprofen-PEG8-ester | N/A | Ev. Tox | Oral |
| Flubiprofen-PEG9-ester | N/A | Ev. Tox | Oral |
| Flurandrenolide 21-aldehyde impurity | 89945-63-1 | Ev. Tox | Topical |
| Flurbiprofen impurity A | 6341-72-6 | Ev. Tox | N/A |
| Fosfomycin impurity A | 84954-80-3 | Ev. Tox | N/A |
| Fosfomycin impurity B | 1262243-11-7 | Ev. Tox | N/A |
| Fosfomycin impurity D | 1262243-12-8 | Ev. Tox | N/A |
| Fosfomycin methoxy hydroxy impurity | N/A | Ev. Tox | N/A |
| Fructose | N/A | Ev. Tox | N/A |
| Fulvestrant sulfone impurity | 98008-06-1 | Ev. Tox | Intramuscular |
| Gabapentin impurity A | 64744-50-9 | Ev. Tox | Oral |
| Gelatin | 9000-70-8 | Ev. Tox | Oral |
| Glyceryl monolinoleate | 26546-74-4 | Ev. Tox | Oral |
| Glycopyrrolate impurity J | 427-49-6 | Ev. Tox | Oral |
| Glycopyrronium impurity J mannitol ester | N/A | Ev. Tox | Oral |
| Hexanal | 66-25-1 | Ev. Tox | Intravenous |
| Hydroquinone | 123-31-9 | Ev. Tox | Oral |
| Hydroxy Vitamin D | 19356-17-3 | Ev. Tox | N/A |
| Hydroxypropyl cellulose | 9004-64-2 | Ev. Tox | N/A |
| Icatibant Impurity A | N/A | Ev. Tox | N/A |
| Icatibant Impurity B | N/A | Ev. Tox | N/A |
| Icatibant Impurity C | N/A | Ev. Tox | N/A |
| Icatibant Impurity D | N/A | Ev. Tox | N/A |
| Impurity A Xylometazoline | 81201-80-1 | Ev. Tox | N/A |
| Impurity D of diazepam | 1022-13-5 | Ev. Tox | N/A |
| Isopar K | 64742-48-9 | Ev. Tox | Dermal |
| Itraconazole impurity 1 | 1199350-02-1 | Ev. Tox | N/A |
| Ivermectin hidroxyoxy | N/A | Ev. Tox | N/A |
| Linaclotide impurity I | N/A | Ev. Tox | N/A |
| Lovastatin hydroxy acid | 75225-50-2 | Ev. Tox | Oral |
| Lumisterol 3 | 5226-01-7 | Ev. Tox | N/A |
| L-xylo-hex-2-ulsonic acid | 526-98-7 | Ev. Tox | N/A |
| Macrogol 600 | 23522-68-2 | Ev. Tox | Oral |
| Magnesium | 7439-95-4 | Ev. Tox | Parenteral |
| Mesazaline impurity IV | N/A | Ev. Tox | N/A |
| Metamizol impurity A | 1672-58-8 | Ev. Tox | N/A |
| Metamizol impurity B | 83-07-8 | Ev. Tox | N/A |
| Metamizol impurity C | 519-98-2 | Ev. Tox | N/A |
| Metamizol impurity D | 58-15-1 | Ev. Tox | N/A |
| Metamizol impurity E | 117-38-4 | Ev. Tox | N/A |
| Methocarbamol B-isomer | 10488-39-8 | Ev. Tox | Oral |
| Methotrexate impurity C | 2410-93-7 | Ev. Tox | |
| Methyl linoleate | 112-63-0 | Ev. Tox | N/A |
| Methyl linolenate | 301-00-8 / 7361-80-0 | Ev. Tox | N/A |
| Methyl L-xylo-hex-2-ulosonate | 3031-98-9 | Ev. Tox | N/A |
| Methyl N-(2,6-dimethylphenyl)alaninate | 52888-49-0 | Ev. Tox | N/A |
| Methyl N-(2,6-dimethylphenyl)-N-methylalaminate | 288580-98-3 | Ev. Tox | N/A |
| Methyl N-(2-6-dimethylphenyl)-N-(2-(2-methoxyacetoxy) acetyl)alaminate | 82686-30-4 | Ev. Tox | N/A |
| Methyl N-(2-methoxyacetyl)-N-(o-tolyl)alaninate | 97717-03-8 | Ev. Tox | N/A |
| Methyl oleate | 112-62-9 | Ev. Tox | N/A |
| Methyl palmitate | 112-39-0 | Ev. Tox | N/A |
| Methyl stearate | 112-61-8 | Ev. Tox | N/A |
| Methylamine | 74-89-5 | Ev. Tox | Inhaled |
| Micafungin sodium impurity A | N/A | Ev. Tox | Intravenous |
| Micafungin sodium impurity D | N/A | Ev. Tox | N/A |
| Monopalmitin | 542-44-9 | Ev. Tox | Intravenous |
| Mono-Thio sugammadex | N/A | Ev. Tox | Intravenous |
| Morpholine | 110-91-8 | Ev. Tox | N/A |
| Mupirocin impurity D | 71087-97-3 | Ev. Tox | N/A |
| Mupirocin impurity E | 71087-96-2 | Ev. Tox | N/A |
| Myristic acid | 544-63-8 | Ev. Tox | Ophthalmic |
| N-(2,6-dimethylphenyl)-2-methoxyacetamide | 53823-88-4 | Ev. Tox | N/A |
| N,N-di-4-pyridinyl methanediamine | 4589-32-6 | Ev. Tox | N/A |
| N,N-dimethyldodecylamine | 112-18-5 | Ev. Tox | Parenteral |
| Naloxone n-oxide | 112242-14-5 | Ev. Tox | N/A |
| N-desmetil ciclobenzaprina | 303-50-4 | Ev. Tox | N/A |
| Ortho/Para menadiol sodium monophosphate | N/A | Ev. Tox | Parenteral |
| Oxidized dimer of α-lipoic acid | N/A | Ev. Tox | Parenteral |
| Paracetamol Dimer Impurity | 98966-14-4 | Ev. Tox | Parenteral |
| P-Chloronitrobenzene | 100-00-5 | Ev. Tox | Oral |
| p-hydroxybenzoic acid | 99-96-7 | Ev. Tox | Parenteral |
| Picloram | 1918-02-1 | Ev. Tox | N/A |
| P-Nitrophenol | 100-02-7 | Ev. Tox | Oral |
| Polyacrylate (polyethyl acrylate) | 9003-32-1 | Ev. Tox | Ophthalmic |
| Previtamin D3 | 1173-13-3 | Ev. Tox | N/A |
| Proparglyoxybenzyl acid | 2766-01-0 | Ev. Tox | Parenteral |
| Propenylphosphonic acid | 25383-06-6 | Ev. Tox | Oral |
| p-sodium | N/A | Ev. Tox | Oral |
| Pyrogallic acid | 87-66-1 | Ev. Tox | Oral |
| Queriapine hemifumarate ester | N/A | Ev. Tox | N/A |
| Riboflavin-5'-phosphate methyl ester | N/A | Ev. Tox | Oral |
| Rosuvastatin anti-isomer | 1094100-06-7 | Ev. Tox | N/A |
| Rosuvastatin Impurity A | 1714147-50-8 | Ev. Tox | N/A |
| Rosuvastatin Impurity E | N/A | Ev. Tox | N/A |
| Rubber oligomer C13H24 | N/A | Ev. Tox | Oral |
| Rubber oligomer C21H40 | N/A | Ev. Tox | Oral |
| Ruscogenin impurity IDN 6208 and 6209 | N/A | Ev. Tox | N/A |
| Ruscogenin impurity IDN 6210 | N/A | Ev. Tox | N/A |
| Ruscogenin impurity IDN 6315 | N/A | Ev. Tox | N/A |
| Ruscogenin impurity IDN 6316 | N/A | Ev. Tox | N/A |
| S-Carboxymethyl-L-cysteine sulfoxide | N/A | Ev. Tox | N/A |
| Sitagliptin impurity A | 2088771-60-0 | Ev. Tox | Oral |
| Sitagliptin impurity B | 2088771-62-1 | Ev. Tox | Oral |
| Sitagliptin N-Formyl | N/A | Ev. Tox | Oral |
| Sitagliptin Urea | N/A | Ev. Tox | Oral |
| Sitagliptin Urea B | N/A | Ev. Tox | Oral |
| Sugammadex disulfide | N/A | Ev. Tox | N/A |
| Sugammadex IMP-DT-SGM | N/A | Ev. Tox | Intravenous |
| Sugammadex monosulfoxide impurities | N/A | Ev. Tox | Intravenous |
| Sugammadex monosulfoxide SGT-R1 | N/A | Ev. Tox | Intravenous |
| Sugammadex sulfone/disulfonide | N/A | Ev. Tox | Oral |
| Tachisterol D3 | 17592-07-3 | Ev. Tox | N/A |
| Tamoxifen | 10540-29-1 | Ev. Tox | Oral |
| Tamoxifen N-oxide | 75504-34-6 | Ev. Tox | N/A |
| Tetrabromocatechol | 488-47-1 | Ev. Tox | Oral |
| Thioctic acid impurity B | N/A | Ev. Tox | Oral |
| Ticagrelor S-Oxide | 1644461-85-7 | Ev. Tox | N/A |
| Tigecyccline C4-epimer | 1422262-97-2 | Ev. Tox | N/A |
| Trans vitamin D3 | 22350-41-0 | Ev. Tox | N/A |
| Triamcinolone acetonide 21-aldehyde hydrate | 166740-69-8 | Ev. Tox | N/A |
| Triphenylacetic acid | 595-91-5 | Ev. Tox | Oral |
| TRK-750 | N/A | Ev. Tox | Oral |
| Trometamol | 77-86-1 | Ev. Tox | Oral |
| Vildagliptin amide impurity | 565453-39-6 | Ev. Tox | Oral |
| Vildagliptine amidine impurity | N/A | Ev. Tox | N/A |
| Vitamin A (Retinol) | 68-26-8 | Ev. Tox | Oral |
| α-Naftol y compuesto relacionado H | 90-15-3 | Ev. Tox | Oral |
| Irgafos 168 | Lixiviable | ||
| Doxorubicin hydrochloride | |||
| Hydrazine sulfate | |||
| (+)-(14beta)-Dihydrovinpocetine | 57327-92-1 | M7 | |
| (+)-Epinephrine | 150-05-0 | M7 | |
| (2,5-dichlorophenyl) methanol | 34145-05-6 | M7 | |
| (2,6-dichlorophenyl) methanol | 15258-73-8 | M7 | |
| (2-chloroethyl) dimethylamine | 107-99-3 | M7 | |
| (3,4-dichlorophenyl) methanol | 1805-32-9 | M7 | |
| -[4-[[2-[3-[[4-(2-carboxyphenyl)phenyl]methyl]-7-methyl-2-propylbenzimidazol-5-yl]benzimidazol-1-yl]methyl]phenyl]benzoic acid | 884330-14-7 | M7 | |
| 1-(1-pyridin-2-yethyl)-2,3-dihydroinden-1-ol | N/A | M7 | |
| 1,1'-(oxydimethylene)bis(2,4-dichlorobenzene) | N/A | M7 | |
| 1,1-dichloroacetone | 513-88-2 | M7 | |
| 1,1-dimethylethyl 4′-(bromomethyl)biphenyl-2-carboxylate | 114772-40-6 | M7 | |
| 1,1-dimethylethyl 4′-[[4-methyl-6-(1-methyl-1h-benzimidazol-2-yl)-2-propyl-1h-benzimidazol-1-yl]methyl]biphenyl-2-carboxylate | 144702-26-1 | M7 | |
| 1,1-dimethylguanidine | 6145-42-2 | M7 | |
| 1,2,4-dichloro-6-nitrophenol | 609-89-2 | M7 | |
| 1,2-dibromoethane | 106-93-4 | M7 | |
| 1,3,7-trichlorodibenzo-p-dioxin | 67028-17-5 | M7 | |
| 1-[(2′-carboxybiphenyl-4-yl)methyl]-4-methyl-2-propyl-1H-benzimidazol-6-carboxylic acid; 1H-Benzimidazole-6-carboxylic acid | 884330-12-5 | M7 | |
| 11a-Chloro sancycline | N/A | M7 | |
| 1-Decanol | 112-30-1 | M7 | |
| 1-Dimethylamino-2-propanol (DMAP) | 108-16-7 | M7 | |
| 1-dodecanol | 112-53-8 | M7 | |
| 1-Fluoro-2,4,6-trinitrobenzene | 364-44-3 | M7 | Oral |
| 1-hexadecanol | 36653-82-4 | M7 | |
| 1-hydroxy-3,3'-dimethylbutan-2-one | N/A | M7 | |
| 1-Methylbiguanide | 1609-00-3 | M7 | |
| 1-octadecanol | 112-92-5 | M7 | |
| 1-tetradecanol | 112-72-1 | M7 | |
| 2-(1-(1H-Inden-3-yl)ethyl)pyridine | 710950-46-2 | M7 | |
| 2,3,7,8-tetrachlorodibenzofuran | 51207-31-9 | M7 | |
| 2,3,7,8-tetrachlorodibenzo-p-dioxin | N/A | M7 | |
| 2,3-butanedione | 431-03-8 | M7 | |
| 2,4,4'-trichloro-2'-aminodiphenyl ether | 56966-52-0 | M7 | |
| 2,4,4'-trichloro-2'-nitrodiphenyl ether | N/A | M7 | |
| 2,4,8-trichloro dibenzo-p-dioxin | 38964-22-6 | M7 | |
| 2,4-dichloro-6-aminophenol | 627-62-8 | M7 | |
| 2,4-dichlorobenzaldehyde | 874-42-0 | M7 | |
| 2,4-dichlorobenzoic acid | 50-84-0 | M7 | |
| 2,4-dichlorobenzyl acetate | 5468-96-2 | M7 | |
| 2,4-Dichlorobenzyl chloride | 94-99-5 | M7 | |
| 2,4-dichlorophenol | 120-83-2 | M7 | |
| 2,4-dichlorotoluene | 95-73-8 | M7 | |
| 2,5-dichloronitrobenzene | 89-61-2 | M7 | |
| 2,8-dichloro dibenzo-p-dioxin | 38964-22-6 | M7 | |
| 2,8-dichlorodibenzofuran | 5409-83-6 | M7 | |
| 2-isoniazid | 1452-63-7 | M7 | |
| 3,5-bus(pyridin-4-yl)-4-amino-1,2,4-triazole | 38634-05-8 | M7 | |
| 3-aminoiarticaine | 85006-31-1 | M7 | |
| 4-[(1R)-2-(benzylmethylamino)-1-hydroxy ethyl] benzene-1,2-diol | 317351-40-9 | M7 | |
| 4′-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl]biphenyl-2-carbonitrile | 144702-27-2 | M7 | |
| 4′-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl]biphenyl-2-carboxamide; telmisartan amide | 915124-86-6 | M7 | |
| 4′-[[7-methyl-5-(1-methyl-1h-benzimidazol-2-yl)-2-propyl-1h-benzimidazol-1-yl]methyl]biphenyl-2-carboxylic acid | 1026353-20-7 | M7 | |
| 4-amino-2-imino-1-methyl-1,2-dihydro-1,3,5-triazine | 847373-57-3 | M7 | |
| 4-chlorophenol | 106-48-9 | M7 | |
| 4-epiminocycline | N/A | M7 | |
| 4-formylaminoantipyrine, FAA | 1672-58-8 | M7 | |
| 4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazole | 152628-02-9 | M7 | |
| 5,7-Di-tert-butyl-6-hydroxy-3,6-dihydrobenzofuran-2(3H)-one | N/A | M7 | |
| 5a,6 anhydrominocycline | 1665-56-1 | M7 | |
| 6,9-di-tert-butyl-1-oxaspiro[4,5]deca-6,9-diene-2,8-dione | N/A | M7 | |
| 7,10-di-tert-butyl-1-oxaspiro[4,5]deca-7,9-diene-2,6-dione | N/A | M7 | |
| 7,9-di-tert-butyl-2-((2-phenylpropan-2-yl)oxy)-1-oxaspiro[4,5]deca-2,6,9-trien-8-one | N/A | M7 | |
| 7,9-di-tert-butyl-3-(2-phenylpropan-2-yl)-1-oxaspirol[4,5]deca-6,9-diene-2,8-dione | N/A | M7 | |
| 7-monodemethyl minocycline | 4708-96-7 | M7 | |
| Acetic acid | 64-19-7 | M7 | |
| Adenosine | 58-61-7 | M7 | |
| Adrenalone/Epinephrone | 99-45-6 | M7 | |
| Aminopyrine | 58-15-1 | M7 | |
| Ammonium sulphate | 7783-20-2 | M7 | |
| Ampyrone, AA (4-Aminoantipyrine) | 83-07-8 | M7 | |
| Androstenedione | 63-05-8 | M7 | |
| Anthranilic acid | 118-92-3 | M7 | |
| Articaine acid propionamide | N/A | M7 | |
| Articaine isopropyl ester | N/A | M7 | |
| Articainic acid | 114176-52-2 | M7 | |
| Avovincamide | 4880-92-6 | M7 | |
| Benzimidazole | NA | M7 | |
| Benzoyl hydrazine | 613-94-5 | M7 | |
| Biguanide | 56-03-1 | M7 | |
| Bis(trimethylsilyl)trifluoracetamide (BSTFA) | 25561-30-2 | M7 | |
| Butylarticaine | 40766-35-3 | M7 | |
| Caustic soda | 1310-73-2 | M7 | |
| Chloroacetic acid | 79-11-8 | M7 | |
| Chloroacetone | 78-95-5 | M7 | |
| Cyanoguadinine | 461-58-5 | M7 | |
| Cypionic acid | 140-77-2 | M7 | |
| Cypionyl chloride | 104-97-2 | M7 | |
| Decanamide | N/A | M7 | |
| Demeclocycline hydrochloride | 64-73-3 | M7 | |
| Dichloroacetic acid | 79-43-6 | M7 | <= 1 month |
| Didanosine | 69655-05-6 | M7 | |
| Diethanolamine | 111-42-2 | M7 | |
| Diethylenetriamine | 111-40-0 | M7 | |
| Diisonicotinoyl Hydrazine | 4329-75-3 | M7 | |
| Dimethylamine | 124-40-3 | M7 | |
| Dipropylarticaine | N/A | M7 | |
| DO3A | 114873-37-9 | M7 | |
| Eburnamenine- 14-carboxylic acid | 68780-79-0 | M7 | |
| Epitestosterone | 481-30-1 | M7 | |
| Ethyl apovincinate | 70155-05-4 | M7 | |
| Ethylarticaine | N/A | M7 | |
| Ethylene glycol | 107-21-1 | M7 | |
| Ethylenediamide | 107-15-3 | M7 | |
| Gadoterium trinitrate | 10168-81-7 | M7 | |
| Glucose | 50-99-7 | M7 | |
| Glyceryl diacetate | N/A | M7 | |
| Guanosine | 118-00-3 | M7 | |
| Guanylmelamine | 4405-08-7 | M7 | |
| Guanylurea | N/A | M7 | |
| Hydrazine | 302-01-2 | M7 | Oral, inhaled |
| Hypoxanthine | 68-94-0 | M7 | |
| Inosine | 58-63-9 | M7 | |
| Isonicotinamide | 1453-82-3 | M7 | |
| Isonicotinic acid | 55-22-1 | M7 | |
| Isonicotinonitrile | 100-48-1 | M7 | |
| Lisacline | N/A | M7 | |
| Melamine | 108-78-1 | M7 | |
| Mesityl oxide | 141-79-7 | M7 | |
| Methyl 3-[[(2RS)-2-(bromopropanoyl)amino]-4-methylthyiophene-2-carboxylate | 1160919-46-9 | M7 | |
| Methyl 3-[[2-(propylamino) acetyl] amino] -4- methylthiophene-2-carboxylate methanol | N/A | M7 | |
| Methyl 4-methy-3-[[(2RS)-2-[(1-methylethyl) amino] propanoyl] amino] thiophene-2-carboxylate | N/A | M7 | |
| Methylamine | 74-89-5 | M7 | |
| N,N'-Dibenzylformamide | N/A | M7 | |
| N,N'-dibutylacetamide | N/A | M7 | |
| N,N-DImethylformamide (DMF) | 68-12-2 | M7 | |
| N,N-Dimethylmelamine | 1985-46-2 | M7 | |
| N2 methylhydroxy minocycline | N/A | M7 | |
| N-Acetylanthranilic acid | 89-52-1 | M7 | |
| N-Benzyladrenalone | 36467-25-1 | M7 | |
| Nicotinoyl hydrazide | 553-53-7 | M7 | |
| N-methyl-o-phenyldiamine dihydrochloride | NA | M7 | |
| N-nitrobetahistine | 32635-81-7 | M7 | |
| N-nitroso ramipril | N/A | M7 | |
| N-Nitrosoenalapril | N/A | M7 | |
| N-nitrosofolic acid | 29291-35-8 | M7 | |
| N-nitrosolisinopril | N/A | M7 | |
| N-nitrosopropanolol | N/A | M7 | |
| Noradrenaline/norepinephrine | 51-41-2 | M7 | |
| Noramidopyrine, MAA (4-methylamino antypirine) | 519-98-2 | M7 | |
| o-Nitrobenzoic acid | 552-16-9 | M7 | |
| o-Nitrobenzoic acid | 552-16-9 | M7 | |
| p-Acetamidobenzoic acid | 556-08-1 | M7 | |
| p-Aminobenzoic acid | 150-13-0 | M7 | |
| Phenol | 108-95-2 | M7 | |
| Phenylboronic acid and 4-tertbutylboronic acid | 98-80-6 | M7 | |
| p-Nitrobenzoic acid | 62-23-7 | M7 | |
| Propylamine | 107-10-8 | M7 | |
| Propylene oxide | 75-56-9 | M7 | |
| Propylene oxide | 75-56-9 | M7 | |
| P-Toluene sulfonic acid | 104-15-4 | M7 | |
| Pyridine - hydrochloride | 628-13-7 | M7 | |
| RIbose | 50-69-1 | M7 | |
| RRT 0.80 | N/A | M7 | |
| RRT 0.85 | N/A | M7 | |
| RRT 0.88 | N/A | M7 | |
| RRT 1.13 | N/A | M7 | |
| Sancycline | 808-26-4 | M7 | |
| Sitagliptin N-Formil | N/A | M7 | |
| Sodium borohydride | 16940-66-2 | M7 | |
| Sodium lauryl sulfoacetate | 1847-58-1 | M7 | |
| Sulfamidopyrine | 117-38-4 | M7 | |
| Sulful dioxide | 7446-09-5 | M7 | <= 1 month |
| Telmisartan methyl ester dihydrochloride | 528560-93-2 | M7 | |
| Tert-butyl alcohol | 75-65-0 | M7 | |
| Testosterone | 58-22-0 | M7 | |
| Testosterone cyclopentyl acetate | N/A | M7 | |
| Testosterone cypionate methylenol ether | N/A | M7 | |
| Testosterone sulfite | N/A | M7 | |
| Tetrachloroethylene | 127-18-4 | M7 | |
| Thiophenol | 108-98-5 | M7 | |
| Triethy orthoformate | 122-51-0 | M7 | |
| Triethylamine | 121-44-8 | M7 | |
| Triethylenetetramine | 112-24-3 | M7 | |
| Triflic acid | 1493-13-6 | M7 | |
| Trifluoroacetamide | 354-38-1 | M7 | |
| Urea | 57-13-6 | M7 | |
Impurezas Mutagénicas
Evaluación toxicológica de impurezas mutagénicas potenciales como las originadas en la vía sintética, según ICH M7.
- Revisiones bibliográficas de los datos de genotoxicidad y carcinogenicidad disponibles.
- Estudios in silico en caso necesario.
- Límite específico para la impureza si se requiere.
Disponemos de un área especializada en soporte toxicológico compuesta por un equipo multidisciplinar de toxicólogos y químicos expertos, acreditados por AETOX, EUROTOX y ERT .
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