what is mean by extactable and leachable study?
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how we can identify the impurity is coming below loq at transfering site?
When recording an IR spectrum in the lab, we take no special precautions to account for the presence of oxygen, nitrogen, or argon in the air. What are the consequences of this?
What is the difference between Normal phase method & Reverse method in HPLC ? Define application of both method.
which situation gc hs and gc als require to use?
How to set analyticl specification for combination products?
Which parameter require to do for analytical method equivalency?
What is the defination of Bulk density?
what is peak purity and its formula
In case of dissolution test, if there is variation within 6 individual units however the batch is complying as per S1 criteria, is it necessary to do investigation for the same? What should be the criteria for such variation?
i set electrode to 7 buffer than i used it to check 4 buffer and 10 buffer if the results are not as expected than is it better to set the buffer again to 4 buffer or is there any other method available please let me know ...
give me method of calculating co relation of coefficient for HPLC,SOR & ANY OTHER
Is it necessary to validate both assay and related substances for usp official methods for products.