Any molecule is filing for ANDA purpose, what are the
dissolution requirements / specifications needed ?
- 1 Answers
- 5400 Views
- IPCA, I also Faced
- E-Mail Answers
Answer / bharadwaja
anda filing is done for generic drugs , for the requirements
of dissolution first refer to innovators dissolution studies
and later check the pharmacopeia of particular country in
which it is to be marketed and check the site of ogd to get
the details of the medium and apparatus to be used ...
| Is This Answer Correct ? | 9 Yes | 0 No |
Why karl fisher factor is 5 ?
what is mean by profiling of dissolution
At what distance the sample is collected in dissolution basket?
What is the importance of sulphated ash test?
What is the role of SO2,I2, Methanolic hydroxide and any base in Karlficher titration
2 Answers Medley Pharmaceuticals,
What is the calibration of uv process and preparation
Which detector is used in uv-vis spectrophotometer?
What does theoretical plates number mean?
Which buffer is used for LC/MS mobile phase & at What Conc.
As per USP u/vacuum means (how much vacuum should be applied)?
How do we fix the sample concentaryion in hplc method development. What is the basis?
Why noise test is performed at 254 nm in calibration of HPLC system?
Organic Chemistry 
