Answer Posted / nikhil gandhi

Method is already Pharmacopial so only need some
varification parameter like Specificty & Precision & Force
Degradation is required for Assay & Related Compound only.
(due to excipient.)

inhouse product is in capsule form in combination and RLD is in tablet form then can we proceed for multimedia CDP? in inhouse capsule product disso is paddle with sinker in release media is there then RLD product in tablet form then with same as paddle with sinker we can proceed n.a.?

771

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sop of a uv visible spectrophotometer double beam elico model

5988

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Is it nessesary all multimedia dissolution require descriminatory?

856

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

1650

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what is mean by 40 in the dissolution basket mesh size?

836

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

2678

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if you given one product then which tests you will perform?

749

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If we have 5 strength which is not dose proportinate and excipients also diffrent in each strength then how we can proceed for Force degradation? and excipient are same but not dose propotinate the how FD?

858

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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?

2112

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UV and PDA detector, which have less signal to noise ratio?

1177

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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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before starting analytical method valodation what you checking? and how giving preference to start validation?

858

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which batch require to use for analytical method validation?

857

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what is definition of validation? which components are followed give detail?

2445

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How can the GC or HPLC method is selected to determine the impurity profile in drug product?

7675

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