Any molecule is filing for ANDA purpose, what are the dissolution requirements / specifications needed ?
IPCA,
1 6356I 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 10120what parameters we will consider while developing a HPLC method and how we confirm our HPLC method is valid?
3691Post New Analytical Chemistry Questions
Why we check moisture,ash & AIA in product
What is rs test why we are performing rs test?
If inhouse hplc related substance method is completly diffrent from Usp for finished proďuct with diffrent impurities then how require to prove method equivalecy?
How can the GC or HPLC method is selected to determine the impurity profile in drug product?
what is the acceptance criteria for enteric coated tablets in 0.1n hcl validation in each parameter?
what is mean by nitrosamine impurities?
why lactose has less charges when packed in steel containers when compared with packing of lactose in polyamide material?
for which product require to do content uniformity? what is limit of cu?
For standardization of volumetric solutions, acceptance limit for concentration is considered as 10% of nominal concentration and %RSD as NMT 0.2% (for appropriate no. of replicates). But , if %RSD has not met, what should be further action?
What is the purpose of octyl silane columns?
what is difference in ods I ods II is this is realy from sorbent / packing characteristics or from other means
What is shaking level in GC?
What is the Formula for coreletion coefficient in plhplc calibration
how to get accurate result for Residue on evaporation in purified water
why octanol used to determine the partition coefficient ?