Answer Posted / ankur dwivedi

There is no any thumb rule that the runtime should be 3
times than main peak, but also depends on the late eluting
impurities in compound; which should be confirmed at the
time of method development. Considering all these, the run
time should be selected.

Ankur Dwivedi
ZCL Chemicals, Ankleshwar

What if impurity area in control sample coming more as compared to LOQ level of impurity ?

1577

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what is impurity profile. how to interpret this impurity profile to a drug product or drug substance.

2598

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how to develop the icp ms method? Application of icp ms?

772

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In HPLC calibration, caffeine is used as primary standard for wave length calibration due to caffeine is having dual maxima at 273 & 205 nm and one minima at 245 nm. Any body can give reference of these details from any pharmacopeia (with chapter no.) or any other authentic guideline?

1943

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What is aggregate and fragments in SEC?

2077

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What are usp limits for theoritical plats,resoution,tailing factor,peak to valley ratio

1871

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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.

2279

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In which situation we require to analytical method validation of excipient?

752

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AT WHAT CONDITIONS WILL YOU ANALYSE A SAMPLE,WHICH ARE PRESERVED AT OTHER THAN THE AMBIENT CONDITIONS?(ie COLD STORAGE SAMPLES BELOW 20* CENTIGRADE?

2030

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

908

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how decide the clining method and cleaning method validation require for this perticular products?

720

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Related substance method equivalency on control sample or spiked sample?

734

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if you get peak in blank then what require to do?

924

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why octanol used to determine the partition coefficient ?

2423

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what is mean by ambient temperature?

892

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