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on what basis SOP's can be changed? IF mobile phase ratio
is 70:30 to how much % can we change the ratio in HPLC
process
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Answer Posted / arjun singh
1 )As per USP guideline the MP can be changed +- 10%, but
to get better accuracy it should not across the +- 5 % and
the same change should be written in SOP with justification
by giving all data accuired in case of changes. it should
be included in in house specification and same can be used
in routine practice
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