High molecular weight Impurities in protien thereopeutics

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bitechdesk
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High molecular weight Impurities in protien thereopeutics

What is method Catagory as per ICH Guide line on analytical method validation  or USP < GEN CHASPTER ON ANALYTICAL METHOD VALIDATION > for Analytical SEC for High molecular  weight Impurities in protien therapeutics , wether its limit test or quantative test ? validation parameter r set diffrent for these ?