Is it necessary to validate both assay and related
substances for usp official methods for products.

Answer Posted / amar

For USP official method, Partial validation required
like Precision, Linearity, Accuracy, Specificity
Because of in our product we will check whether the recovery,
Method Repetability parameters are coming.

Is This Answer Correct ?    10 Yes 1 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

In the HPLC Calibration done wavelength accuracy done between 200nm-280nm .but not done remaining 300-400nm not done ?

465


What is the difference between spectro meter and spectro photo meter?

10437


How do we fix the sample concentaryion in hplc method development. What is the basis?

682


What is the principle of HPLC, GC, LCMS, GCMS,LC QQQ, GC QQQ, LC Q TOF and GC Q TOF. What are the applications and Specificity?

8321


is it nessesary to do solution stability for 7 days?

321






IS THERE ANY EQUIPMENT TO CHECK AND CALCULATE THE POLARITY OF A LIQUID?

1994


what is the extinction coefficient for Indomethacin or at 319nm wave length.

3525


We use hicrome 10 cxs column in hplc analysis....pls tell me.. what is the meaning of 10 cxs?

1163


why require to add enzymes in capsules dissolution only? is it require to tablet also?

273




1825


How will u perform degradation study in detectors other thann PDA in HPLC Methodology

2024


how require to select dissolution media? what is discrimination?

320


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.?

297


How do we get end points and how many end points are possible for citric acid and di-acid not theorotically answer should be given practically.

2058


why we are using benzene, anyline in acetic anhdride assay titration method?

1584