We have vast experience in the synthesis of complex molecules and we are able to provide in-house pharmacopeial impurities to our clients and fulfil their regulatory requirements. We have more than 5000 pharmacopeial inhouse impurities are in-stock.
We need to confirm the structure of impurities by EP/BP/USP followed by to check the purity by method of HPLC analysis which mentioned in pharmacopeia.
We provide CoA & all characterization data which mentioned below to our customers.
CoA : Certificate of analysis.
HPLC : High performance liquid chromatography
NMR : Nuclear Magnetic Resonance spectroscopy
Mass : Mass spectroscopy by Electrospray ionization (ESI) and Atmospheric Pressure Chemical Ionization (APCI).
IR : Infrared spectroscopy
TGA : Thermogravimetric analysis
Potency : Calculation mentioned below
% of Potency = [100 – (Wt loss by TGA) – (ROI) x HPLC purity/100 = % of potency