Answer / ichinnakamisetti

Are the stability results out-of-trend without an obvious root cause? Maybe the decrease in assay can be explained by an increase in water content. Non-solid product or raw material can be released without testing the water content. The amount of water is needed to calculate the purity ‘as is’ of a product and to evaluate compliance with the specification set

How to select Sample concentration in RS analysis?example.

1 Answers  

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Difference between related substances & impurities

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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?

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What is the difference between GSC & GLC?

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What is the diference between residual solvents and organic volatile matter

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What are the class-1 residual solvents listed in ICH guidelines?

2 Answers  

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