Is it necessary to validate both assay and related
substances for usp official methods for products.
- 6 Answers
- 11885 Views
- Apotex, I also Faced
- E-Mail Answers
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
How we choose the mobile phase for method development.?
How to set analytical specification for combination products?
for which product require to do content uniformity? what is limit of cu?
if tech transfer fails whay require to do?
A ha tc is actual defination of retention time?
what is the difference between potentiometric titration and karl fischer titration?
What is importance of pH in the Heavy metal test and How it effect on the test results?
How to know the estimated LOQ concentration in ppm
what is difference in ods I ods II is this is realy from sorbent / packing characteristics or from other means
what is mean by 40 in the dissolution basket mesh size?
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.
Is it nessesary all multimedia dissolution require descriminatory?
[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?
What is stray light in uv what are units for stray light
why should we perform dissolution PVT calibration only by UV spectrometer, not by HPLC ?
