In case of dissolution test, if there is variation within 6
individual units however the batch is complying as per S1
criteria, is it necessary to do investigation for the same?
What should be the criteria for such variation?
- 2 Answers
- 4368 Views
- I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / sasikumar.r
Not necessaty to investigate.....
As per USP Acceptance Criteria for
S1 is 6 Each unit is not less than Q + 5%.
If individual values passes the Q+5% means, that batch passes the dissolution..
| Is This Answer Correct ? | 3 Yes | 0 No |
Answer / b.kishan reddy
Dear @Shasikumr %RSD Should be match for the 6 Units. Generally it is 5%.
| Is This Answer Correct ? | 0 Yes | 0 No |
how do u optimise hplc method
If mass balance is not passing in forced degradation in method validation that method is suitable or not?
1 Answers Aurobindo, Dr Reddys, Reddy Labs, Wockhardt,
How they found 1mL of K.F reagent is equivalent to 5mg of water and if we change the composition of K.F reagent, is it can neutralize more amount of water?
What is the principle of hplc detectors like.. UV detector,flurosence detector, RID?
What is Stray light ? & what is the IMP of this
give me method of calculating co relation of coefficient for HPLC,SOR & ANY OTHER
What is difference between Chromatographic purity and Related substances analysis?
what is principle of XRD?
why we use 0.1% acetone in gradient calibration of HPLC?
3 Answers Cipla, Dr Reddys, FDC,
Dear Sir, This is Thirunavukkarasu am working in Ordain Health Care AR&D, Am Having one problem While doing method development my question Metadoxine and Pyridoxine same chemical nature and structural activity i tried lot of methods but Analyte eluted same Retantion time i cant separate both peaks. solubility, pH both are same only only difference melting point metadoxine 210 C Pyridoxine 102 C please do the help needful for me
Is there any difference in principal of reverse phase and normal phase chromatography? and why? Please update. Thank and regard
How we develop a method by HPLC for unknown compound,if we got three peaks with same response then how we can find out which one is our desired compound's peak without taking help of LC MS.
Organic Chemistry 
