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Centre Testing International Co., Ltd. (CTI) is the pioneer and leader in the TIC Industry which provides one-stop solutions on testing, inspection, certification, calibration, audit, training & technical services.

 
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Our service capabilties cover the upstream and downstream of the supply chain including textile and apparel,toys,electronic appliances,medical health,food...andother industries.
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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.

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

序号

英文名

缩写

CAS No.

EP收载

USP收载

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

    

Service process

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