IndiaPharmaceuticalsIndia: Pyridine (Quality Control) Order, 2020

India: Pyridine (Quality Control) Order, 2020

 

India has published the Pyridine (Quality Control) Order, 2020.

As per the Order, pyridine will have to be certified according to the Indian Standard of Pyridine Specification (IS 8058: 2018) and bear the Standard Mark under a licence from the Bureau as per the Scheme-I of Schedule-II of the Bureau of Indian Standard (Conformity Assessment) Regulations, 2018.

Pyridine is used as solvent in dyestuff industry, pharmaceutical industry and as a laboratory reagent. It is also used in the manufacture of drug intermediates like 2- aminopyridine, 2, 6-diaminopyridine, pheniramine, vitamins, adhevies, food flavouring agent etc. it is also used in the manufacture of pesticides. The Indian standard of pyridine stipulates minimum purity content, and maximum limit of impurities such as copper content, ammonium compounds, chlorides and sulphates etc.

Since pyridine finds application in the manufacture of pharmaceuticals, its quality need to conform to the BIS standards otherwise impurities present in Pyridine enter the animal & human chain. The locally manufactured or imported Pyridine shall conform to the Indian standard (IS 8058: 2018) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS).

The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.

The text of the order is available HERE

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