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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 / ashwani kumar mahajan (drl)
1 )+- 10% as per USP guideline mp ratio can be changed
2)SOP must be there for reason /justification inclusion SOP
Can be modified
3) Inhouse validation data shold be available for
perticular product then this change will be acceptable to
pharmaceopia .
| Is This Answer Correct ? | 4 Yes | 0 No |
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