Answer / balaji n

Dissolution profile means
collecting samples at different time points while
performing dissolution with respect to the nature and type
of formulation(IR,SR,MR etc).

Dissolution profiling will help you to find the
discreminating power,samness with innovator sample and also
as reference during other investicational studies.

Dissolution profile comparison
1. For accepting product sameness under SUPAC-related
changes.
2. To waive bioequivalence requirements for lower strengths
of a dosage form.
3. To support waivers for other bioequivalence requirements.

Through assay by hplc(anhydrous basis) product got 100.8% .How much the potency of that product.Moisture content is 1.7%,Sulfated ash is 0.02%,Total impurities are 0.3%

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why are measure gas flow " ml " in Gas chromatography

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How we performed the force degradation for drug substance, is any specific guideline is available for each parameter(Acidic, basic, oxidation,heat)? what conditions you mentained for above parameters.

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Can we do the MC analysis of a sample which is not completely soluble in the medium choosed.

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Why noise test is performed at 254 nm in calibration of HPLC system?

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What are the terms used during Melting Range Analysis ?

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k.f principle in finding out moisture content

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How to establish relative response factor for hplc. Why it is required?

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why we are using in ph calibrations ph4,7,9.2 buuffers only?

3 Answers   Reddy Labs, Unichem,

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In specificity what parametrs are consider why that parametrs

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What is Endcapped Hplc column

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if partition coefficient value was positive means, what it indicates ?

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