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Starting materials in pharma as well as biologicals

Hi,
Kindly provide me the definiton of starting material used in pharmaceuticals as well as in biologicals :slight_smile:

[quote=saleem.shaikh]Hi,
Kindly provide me the definiton of starting material used in pharmaceuticals as well as in biologicals :)[/quote]

Dear Saleem,
The quality of raw materials for the production of starting materials, including purification steps, and quality control of the finished product – including inprocesscontrols, batch release and, if appropriate, the stability of the product in its container. The production of quality starting materials must be carefully planned in order to obtain starting materials which are both suitable and safe for the intended purpose.

Thanks

[quote=saleem.shaikh]Hi,
Kindly provide me the definiton of starting material used in pharmaceuticals as well as in biologicals :)[/quote]

Dear All
Active pharmaceutical ingredients starting material (APISM)is the one which is incorporated into the new drug substance as an important structural element. For a manufacturer APSIM should meet certain criteria; It should be a known compound whose name, chemical structure, chemical and physical characteristics and properties and impurity profile and sythesis are well defined in the chemical literature. Its source and synthetic procedureshould be declared, this applies principally to starting materials extracted from plants and animals and to semisynthetic antibiotics).

It is mendatory to provide information about starting material in DMF (e.g. some starting materials for semisynthetic antibiotics). When the starting material is itself a drug substance, the synthesis of this material should be provided either in full or by authorized reference to an NDA or DMF.

Dear Sir,
Thank you very much for guidence.:slight_smile:
Regards,
Saleem.