Answer Posted / mayank sanghvi

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.

what is the procedure for cleaning of lenses of hatr accesory of ftir instrument?

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If suppose 10 methods of dissolution given in pharmacopoeial for single content product then which method out of 10? or all 10 require to follow?

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What is column in chromatography?

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How can I develope method of dissolution by HPLC OR UV

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What is dose dumping? why require to do?

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if you given one product then which tests you will perform?

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What is the requirement for brazil in the analytical method vslidation comparr to ich?

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Hi sir if any product monograph not given known impurities (may be 5 impurities) specifications then how we require to proceed for inhouse formulation?

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What is the difference between chromatographic purity and related substances?

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inhouse product is in capsule form in combination and RLD is in tablet form then can we proceed for multimedia CDP? in inhouse capsule product disso is paddle with sinker in release media is there then RLD product in tablet form then with same as paddle with sinker we can proceed n.a.?

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What is a difference between potency and purity?

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how require to select dissolution media? what is discrimination?

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please explian me about area normalisation method,diluted standard method,impurity vs impurity and which one has to be selected in method development

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Why sometime potassium ortho phosphate mix with acetone use for sample preparation for hplc

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In HPLC (Waters) software Empower1,2 &3 what is the updation for each version

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