Interested to Buy Any Domain ? << Click Here >> for more details...
Is it necessary to validate both assay and related
substances for usp official methods for products.
- 6 Answers
- 14276 Views
- Apotex, I also Faced
- E-Mail Answers
Answer Posted / akshay
Partial validation need to do. Different path of synthesis can be use by diff. Manufacturar so need to study impurity profiling, solvents etc.
| Is This Answer Correct ? | 3 Yes | 0 No |
Post New Answer View All Answers
A ha tc is actual defination of retention time?
why lactose has less charges when packed in steel containers when compared with packing of lactose in polyamide material?
How can we calculate "confidence interval" in analytical method validation? Pl. explain with example.
In HPLC (Waters) software Empower1,2 &3 what is the updation for each version
Which type of column should i use to check the purity of high molecular weight protein using HPLC reverse phase column chromatography? Hi everyone. I wanna to check the purity of high molecular weight protein (collagen) with MW of ~130 kDa using a HPLC. I know C18
why we use glass fiber filters use in some situation?
Why potassium dichromate is used in calibration of uv?
Difference between hlaf and rlaf
Hi sir if any product monograph not given known impurities (may be 5 impurities) specifications then how we require to proceed for inhouse formulation?
for inorganic molecules require to do RS, Assay and disso?
why glutent are detected in the rice cereal baby food product even manufacturer claimed that they are using rice and milk only?we have using ELISA to do the test,and rice supposed not containing any glutent,rite?We already repeat the test so many times and it still detected.just wondering where the glutent came from?
on saturation solubility study data how we can find out the bcs class of drug?
calibrtion procedue of LC-MS
How require to perform linearity as per ANVISA? What are the acceptance criteria?
WHAT IS THE USE OF STARTER ?????????
