Auriga Labs provide Genotoxin Nitrosamine Testing and Analysis in Pharmaceuticals

Auriga Labs provide Genotoxin Nitrosamine Testing and Analysis in PharmaceuticalsNitrosamine testing lab services are in demand ever since the prescription pharmaceutical drug ranitidine and subsequently may rugs like metformin, sartans  etc have been in the news for nitrosamine contamination.

Ranitidine is used for the treatment and prevention of ulcers in the stomach and intestines and for gastroesophageal reflux disease. However, the discovery of genotoxic impurity N-nitrosodimethylamine (NDMA) at low levels in some medicines, including Zantac has led to some concern among pharmaceutical manufacturers.

The nitrosamine impurity NDMA is classified as a probable human carcinogen and is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. After the discovery of NDMA by USFDA, the Drug Controller General of India has also written to state drug controllers, asking them to draw samples of ranitidine API (active pharmaceutical ingredient) from major manufacturers as well as fast-running product formulations of ranitidine and send those to Central Drug Laboratory (CDL) in Kolkata to test for the impurity.

However, all pharmaceutical testing laboratories do not have the necessary equipment or the technicians to conduct the specific testing to analyse the levels of NDMA and other nitrosamines as they are mostly present only at ppm levels. Genotoxins at any level are considered unsafe and therefore there is a need to detect their presence as they can cause adverse health effects.

New LC-MS/MS installed at Auriga
LC-MS/MS installed at Auriga

Arbro & Auriga Labs have the know-how and the equipment to carry out nitrosamine testing lab services for all kinds of genotoxins including NDMA. Arbro & Auriga labs are NABL accredited ISO/IEC 17025 certified. Auriga Labs are DCGI approved and have and has a BE Centre approved by NPRA (Malaysia). Arbro and Auriga labs have successfully carried out testing and completed projects on;

NDMA, Chloroacetonitrile, 2-Bromo aniline, Mandalic acid, Methane Acid (Formic acid), Methyl Acetoacetate, Methyl Methane Sulfonate, Ethyl Methane Sulfonate, Carbon tetrachloride, Gluconalactone, Methane sulfonic acid, 1, 1, dichloromethane, 1,1-Dichloroethene, 2,4-Dimethyl benzene-1-sulfonyl chloride, Methane sulfonic acid ethyl ester, Methane sulfonic acid methyl ester, P-Anisidine, 4-Nitroaniline, 2-amino acetophenone. 1-Bromo-2 Butyne, 2-Chloro-1-(4,Flourophenyl)-2-Phenylethanone,(Z)-2,2,2-Trifluoro-N-(Piperazine-2-ylidene)acetohydrazide, (S)-2-(3-CHLORO-2-HYDROXYPROPYL)ISOINDOLINE-1,3-DIONE, (S)-(+) Epichlorohydrin, (S)-2-(Oxiran-2ylmethyl)isoindoline-1,3-dione, Tert Butanol,  N,N-Dimethyl aniline, Trifluoro acetic acid, Hydrazine Hydrate etc.

Impurity NameAcceptable Limit (ng/day)
MeNP26.5
NDEA26.5
NEIPA/NIEA/NIPEA/EPINA26.5
NDIPA26.5
NDELA26.5
NDPA26.5
NDBA26.5
NMEA26.5
N-Ethyl-N-Nitroso-ethane-1,2-diamine26.5
NMPA26.5
NMBA96
NDMA96
NMOR127

Arbro & Auriga labs have the latest instruments and use the correct methods for detection of genotoxic impurities in drug substances and drug products like LCMS-MS, GCMS-MS, GC-HS. We carry out elemental impurity analysis, using ICP-MS or ICP-OES. The labs are also experienced in carrying out developmental and validation testing using LCMS-MS, GCMS-MS, ICP-MS, ICP-OES, AAS, HPLC, GC

Testing
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