Answer Posted / rameshpandey

1 Stationary phase
2 Oven programme
3 Inlet temperature
4 Detecture temperature
5 Column flow
6 Incubation temperature,incubation time, syringe temperature and transferline temperature
7 diluent

What is the accrptance criteria in RSD for RS method precision on basis of impurity percentages?

831

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in DMF having extra impurities and in api COA also having extra imp than USP or BP product then how require to proceed?

844

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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.

2313

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for heavy metal test lead used in which form pure form or any other form for preparation of lead standard sol

6073

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Please tell me about the pH of Polycaboxylic ether is it in the 5-6 range ever or more than 6

2610

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in hplc chromatogram started from left to right and in uv spectrum started from left to right

954

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How to know the estimated LOQ concentration in ppm

1217

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what is difference in ods I ods II is this is realy from sorbent / packing characteristics or from other means

1977

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what is mean by extactable and leachable study?

1180

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What is related substance by HPLC impurity limits as per USP?

1110

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What is Band broading effect explain

1886

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in which situation require to take incident in validation?

1728

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in stress study if your api not soluble in hcl naoh h2o2 then what require to do?

844

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2. Two grams of Benzoic acid are dissolved in 200 ml of water and extracted with 200 ml of diethyl ether. The distribution coefficient of benzoic acid is 100, and its dissociation constant is 6.5 10-5. Calculate the distribution ratio (D) of benzoic acid at pH 2, 5, and 6. 3. Calculate D at pH 2 to 10 (1 unit apart) in the above problem, and plot D versus pH.

2224

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why we should take dst factor for below 1%moisture samples

2671

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