Answer Posted / nimesh trivedi

Calibration means system performance checking
Validations means Mfg. Process or analytical method performance checking

If vendor having more imp than monograph then how to proceed? and how to set spec?

1004

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If inhouse hplc related substance method is completly diffrent from Usp for finished proďuct with diffrent impurities then how require to prove method equivalecy?

817

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Which products will produce when acetic anhydride reacts with Ter-butanol, Sec-butanol, Iso butanol, Dimethylamine etc.

2911

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Why we check moisture,ash & AIA in product

1942

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in which situation require to change rs specification?

797

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How you develop a method in HPLC?

2667

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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.

2359

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in OSD forms require to use gas chromatography?

874

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What is control room temperature and which guide line says?

1696

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Why irmoisture balance is used for corrugated box moisture testing

2451

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why should we perform dissolution PVT calibration only by UV spectrometer, not by HPLC ?

1753

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My question about gas chromatography sulfur chemiluminsecence detector. I test unknown sample gas by GC-SCD (calibrated ) and the result of *H2S is 279 PPM , *but when I test the same sample with the GC-TCD (calibrated ) the value of *H2S is 2500 PPM . I'd like to inform you that both GCs are calibrated and have very good operation conditions with stable parameters . the question is if the sample gas with higher H2S over detection limits of SCD detector (1000 ppm). why the result it 279 ppm Best regards

1653

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If combination product how require to identify which imp is of which api?

865

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how can give the expiry period and restadardisation of volumetric solution

2643

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how to calculate elemental impurities?

1086

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