Ranitidine, also known as N-Nitrosodimethylanine which is the latest product of Pharmaffiliates. We are one of the largest manufacturer/supplier/exporter of reference standards in worldwide.

1. Carcinogen Alert
Ranitidine Under The Lens

2. 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.

3. 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.

4. 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.

5. 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.

6. 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

7. 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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8. Pharmaffiliates
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India
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+91-90410-78188
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