As you already know that the prescription pharmaceutical drug ranitidine has been in the news. Ranitidine is used for the treatment and prevention of ulcers in the stomach and intestines and for gastroesophageal reflux disease. However, the discovery of genotoxin impurity N-nitrosodimethylamine (NDMA) at low levels in some medicines, including Zantac has led to some concern among pharmaceutical manufacturers.
The 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 US based FDA, 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 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.
Fortunately, Arbro & Auriga Labs have the know-how and the equipment to carry out testing 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;
Methane sulfonic acid
1, 1, dichloromethane
Methane sulfonic acid ethyl ester
Methane sulfonic acid methyl ester
2-amino acetophenone. 1-Bromo-2 Butyne
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. It carries 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