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Re: Endotoxins inexcipients

Dear Mr Rana,

You need not do the tests for endotoxin for the excipients and API , unless
specified by Pharmacopoeia.(If you are denoting the same)
Sourcing the vendors for the same and maintenance of standards / trend is
very difficult.

Of course it is advisable as indicated by Mr. Brian.

But if you get your products failed in endotoxin test,
have you given a thought to reduce endotoxin load  in the formulation by
using a +ve charged membrane filter.

Hope this helps.

D Panda
Validation, OPP


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