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Genetic toxicity (genotoxicity) impurity testing

CTI Pharma and Medical Services provides you with various genotoxic impurity analysis method development and validation services. The analytical method development meets the requirements of the ICH Q14 the analytical method validation meets the requirements of the ICHQ2(R2), USP General Chapter <1225>, ChP General Chapter <9101> and other regulations.

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Genetic toxicity (genotoxicity) impurity testing

? Service Background

Genotoxic impurities in drugs not only have no positive effect on the treatment of patients, but also damage their health. Therefore, pharmacopoeias of various countries have successively promulgated general rules for the control and detection of genotoxic impurities.
The ChP 2020 General Chapter <9306> provide guidance on its hazard assessment methods, acceptable intake calculation methods and limit setting methods.
USP General Chapter <1469>, EP General Chapter <2.5.42> both stipulate the PDE, limit values and methods of nitrosamine genotoxic impurities.

? Applicable Products

Mainly applicable to synthetic APIs, Excipients, Drugs, etc.

? Service Content

Calculate the product limit based on the product usage and dosage and PDE value; develop applicable LC-MSMS or GC-MS test methods based on the solubility and stability of the product, and perform method verification.

? Featured Services

Depend on the highly sensitive of LC-MS/MS, Quantitation Limit of the method can be as low as 10ng for 17 nitrosamine genotoxic impurities. Including 7 nitrosamine substances clearly specified in USP<1469> and EP<2.5.42>, as well as other 9 common nitrosamine substances.
NDMA and NDEA can be tested for 5 APIs according to EP<2.5.42>. The 5 APIs are: Losartan Potassium, Candesartan cilexetil, Olmesartan Medoxomil, Valsartan, Irbesartan.
Nitrosamine genotoxic impurities in products can be qualitatively analyzed according to the ChP 2020 General Chapter <9306> , and quantitative method validation can be performed according to ICH Q2(R2).

17 nitrosamines

序號	英文名	縮寫	CAS No.	EP收載	USP收載
1	N-nitroso-dimethylamine	NDMA	62-75-9	●	●
2	N-nitroso-diethylamine	NDEA	55-18-5	●	●
3	N-nitroso-diisopropylamine	NDiPA	601-77-4	●	●
4	N-nitroso-ethyl-isopropylamine	NEiPA	16339-04-1	●	●
5	N-nitroso-dibutylamine	NDBA	924-16-3	●	●
6	N-ethyl-N-nitroso-aniline	NMPA	614-00-6		●
7	N-nitroso-N-methyl-4-aminobutyric acid	NMBA	61445-55-4	●
8	N-nitroso-dipropylamine	NDPA	621-64-7	●
9	1-Nitrosopiperidine		100-75-4
10	N-Nitrospyrrolidine	NPYR	930-55-2
11	N-Benzyl-N-nitroso-1-phenylmethanamine	NDBzA	5336-53-8
12	N-Methyl-N-nitrosoethanamine	NEMA	10595-95-6
13	N-ethyl-N-phenylnitrous amide		612-64-6
14	N-nitrosomorpholine		59-89-2
15	N-Nitrosodiphenylamine		86-30-6
16	N-Nitrosodiisobutylamine		997-95-5
17	N-Nitroso-N,N-di(3,5,5-trimethylhexyl)amine		1207995-62-7

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