Any molecule is filing for ANDA purpose, what are the dissolution requirements / specifications needed ?
IPCA,
1 6436I want analyze my compound at 325 nm so which standard shall i use to calibrate my HPLC system? How i can assure my hplc detector is suitable or not?
AMRI,
3 10279what parameters we will consider while developing a HPLC method and how we confirm our HPLC method is valid?
3750Post New Analytical Chemistry Questions
what is mean by ambient temperature?
inhouse product is in capsule form in combination and RLD is in tablet form then can we proceed for multimedia CDP? in inhouse capsule product disso is paddle with sinker in release media is there then RLD product in tablet form then with same as paddle with sinker we can proceed n.a.?
WHAT IS THE CRITERIA FOR SELECTION OF TIME OF DISSOLUTION AND THE MEDIUM OF DISSOLUTION?
how you establish the LOQ?
If vendor having more imp than monograph then how to proceed? and how to set spec?
What is the principle of HPLC, GC, LCMS, GCMS,LC QQQ, GC QQQ, LC Q TOF and GC Q TOF. What are the applications and Specificity?
Why we used in n-butyl acetate water content terminology while in ethyl acetate we used moisture content terminology?
How require to perform linearity as per ANVISA? What are the acceptance criteria?
why require to add enzymes in capsules dissolution only? is it require to tablet also?
How to set analyticl specification for combination products?
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
What is shaking level in GC?
How to determine the EDTA content by potentiometry titration in Ceftriaxine sodium
why we are using hexane in calibration of number of drop per mL
Why only Copper standard is used to calibrate Atomic Absorption spectrophotometer?