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Is it necessary to validate both assay and related
substances for usp official methods for products.
- 6 Answers
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Answer / amar
For USP official method, Partial validation required
like Precision, Linearity, Accuracy, Specificity
Because of in our product we will check whether the recovery,
Method Repetability parameters are coming.
| Is This Answer Correct ? | 10 Yes | 1 No |
Answer / nikhil gandhi
Method is already Pharmacopial so only need some
varification parameter like Specificty & Precision & Force
Degradation is required for Assay & Related Compound only.
(due to excipient.)
| Is This Answer Correct ? | 6 Yes | 1 No |
Answer / akshay
Partial validation need to do. Different path of synthesis can be use by diff. Manufacturar so need to study impurity profiling, solvents etc.
| Is This Answer Correct ? | 3 Yes | 0 No |
Answer / gokul yeole (archpharmalabs)
Yes,For USP official method it mens compandial methods
should be validate, Partial validation required
like Robtness,rugdness,Precision, Linearity, Accuracy,
Specificity
Because of in our product we don`t know which system and
lab will use for analysis.
non compandial methods do all parameter which is mentioned
in ICH Q2 guidline.
| Is This Answer Correct ? | 3 Yes | 1 No |
Purity Tests: to ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte, i.e.
related substances test, heavy metals, residual solvents content, etc.
Assay (content or potency):
to provide an exact result which allows an accurate statement on the
content or potency of the analyte in a sample.
| Is This Answer Correct ? | 3 Yes | 1 No |
Answer / venugopal reddy
Based on the USP 1225 generachapter,
Analytical methods described in USP–NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.
| Is This Answer Correct ? | 0 Yes | 0 No |
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