Interested to Buy Any Domain ? << Click Here >> for more details...
stability study is going on up to 3years for famotidine-USP but the pharmacopeia is revised and tlc test is replaced with hplc test. At the 4th year frequency the product is failed in hplc test .how can i assain the expiry or retest date and can i stop or continue the programme?
- 2 Answers
- 6499 Views
- Nakoda Chemicals, I also Faced
- E-Mail Answers
Answer Posted / guest
The product is assigned 3 years expiry.
| Is This Answer Correct ? | 0 Yes | 0 No |
Post New Answer View All Answers
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.
In Dissolution Test why limit is define Q+5% what is the role of +5%.
Hi sir if any product monograph not given known impurities (may be 5 impurities) specifications then how we require to proceed for inhouse formulation?
Did anybody have method for acetyl cysteine effervescnce tablet
Related substance method equivalency on control sample or spiked sample?
What is the formula to determine the concentration of M of a solution given the % transmittance? Use %T = 43.7 as an example.
could negative ions be produced by bombardment process in mass spectrometry?
My question about gas chromatography sulfur chemiluminsecence detector. I test unknown sample gas by GC-SCD (calibrated ) and the result of *H2S is 279 PPM , *but when I test the same sample with the GC-TCD (calibrated ) the value of *H2S is 2500 PPM . I'd like to inform you that both GCs are calibrated and have very good operation conditions with stable parameters . the question is if the sample gas with higher H2S over detection limits of SCD detector (1000 ppm). why the result it 279 ppm Best regards
some product having water content method with pyridine and ethylene glycol mixture instead of methanol? how they are selecting and methanol is not suitable solvent how ?
why require to do water content for drug product?
What is the diffrence in japan mkt requirement in analytical method validation over US?
Why only Copper standard is used to calibrate Atomic Absorption spectrophotometer?
in DMF having extra impurities and in api COA also having extra imp than USP or BP product then how require to proceed?
What is dose dumping? why require to do?
what are risk assement in the analytical qbd?
