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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
- 7 Answers
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Answer / dr.sp goswami
+- 10% as per usp guideline mp ratio can be changedrevised
SOP must be there for reason /justification inclusion SOP
Can be modified
| Is This Answer Correct ? | 15 Yes | 1 No |
Answer / abdulkalim
± 10% is acceptable , but your internal Guidline/SOP should
define the acceptable limit/range.
But in general ± 10% is acceptable.
| Is This Answer Correct ? | 4 Yes | 0 No |
Answer / 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 |
Answer / 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
| Is This Answer Correct ? | 2 Yes | 0 No |
Answer / rajender rangu
We can adjust up to +or - 30% relative.and not mor than 10%absolute value of minor component.
Here we can do up to 60:40 or 80:20
| Is This Answer Correct ? | 0 Yes | 1 No |
Answer / vinod kumar, nektar therapeuti
As per me ±2% change in initial mobile phase composition is
fine to check the ruggedness of the method.
| Is This Answer Correct ? | 0 Yes | 6 No |
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