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|
|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|
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