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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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