Carcinogen Alert – Ranitidine Under The Lens

Published Oct 19, 2019 by pharmaffiliates
Carcinogen Alert – Ranitidine Under The Lens

Ranitidine, sold under the brand name ZANTAC is an OTC drug that is widely prescribed medicine for its multiple implications worldwide. It is on the World Health Organisation’s ‘Model List of Essential Medicines’.

It is estimated, only in In India, a host of companies including GalxoSmithKline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy’s, Sun Pharmaceuticals sell over 180 versions of the drug.

US Food and Drug Administration (FDA) has recently found “unacceptable” levels of probable cancer-causing impurity called “N-nitrosodimethylanine (NDMA) “in the drug.

The carcinogenic impurity N-nitrosodimethylanine (NDMA) has probably arisen due to some changes made in the manufacturing process of the drug Ranitidine.

The medicine watchdog and governing bodies throughout the world have been asking the pharmaceutical manufacturers to suspend the release, distribution, and supply of all dose forms of Ranitidine productsand also to recall the batches of the drug which are available in the market.

In India, Drug Controller General of India (DCGI) directed state drug regulators to ask pharmaceutical companies to check their products for the carcinogenic impurity N-nitrosodimethylanine (NDMA).

To obtain high quality, and high purity Reference standard of N-nitrosodimethylanine (NDMA), the pharmaceutical manufacturers can conveniently join their association with one of the largest manufacturers/supplier/exporter of reference standards PHARMAFFILIATES.

Details of Ranitidine impurity NDMA and other related products which are available at Pharmaffiliates are tabulated below:

S.No Product name CAS No. Product Code
1 N-Nitrosodimethylamine (NDMA) 62-75-9 PA PST 010435
2 1-Nitrosopyrrolidine (NYPL) 930-55-2 PA PST 010355
3 N-Nitrosomorpholine (NMOR) 59-89-2 PA PST 010380
4 Molsidomine - Impurity B 59-89-2 PA 13 49020
5 N-Nitrosodipropylamine (NDPA) 621-64-7 PA PST 010445
6 N-Nitrosopiperidine (NPIP) 100-75-4 PA PST 010350
7 N-Ethyl-N-nitroso-2-propanamine
(N-Nitrosoisopropylethylamine) (NIEA)
16339-04-1 PA 27 02198
8 N-Nitrosodiethylamine (NDEA) 55-18-5 PA PST 010430
(PA 27 00355)
9 N-Nitrosodiisopropylamine (NDIPA) 601-77-4 PA PST 010615
10 N-Ethyl-N-nitroso-2-propanamine (NEIA) 16339-04-1 PA 27 02198
11 N-Nitroso-N-methyl-4-aminobutyric Acid (NMBA) 61445-55-4 PA 27 04182
12 N-Nitroso-di-N-butylamine (NDBA) 924-16-3 PA PST 010425
13 N-Nitrosoethylisopropylamine (NEIPA) 16339-04-1 PA 27 02198

Each reference standards come with a comprehensive Certificate of Analysis detailing the characterization process for the material and ensuring its suitability for both qualitative and quantitative analysis.

Pharmaffiliates Analytics and Synthetics Pvt. Ltd. is a research-based organization and for decades we have supported the pharmaceutical community with high-quality reference standards With more than 100,000 reference standards for pharmaceutical quality control, our quality enables your accuracy, helping you to create even better, safer medicines.

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