Excipients
Excipients
All these products are offered with the followingregulatory support and documentation:
Compliance to ICH Q3D guidelines
Stability Data and shelf-life declaration
Residual solvents compliance certificate
TSE/BSE free certificate
GMO declaration
Latex/ Gluten/ Melamine/ Allergen-free certificate
Specifications, Method of Analysis and CoA
Genotoxic impurities certificate
Vendor Qualification (VQ) questionnaire. Customer VQ formats also supported.
CTD dossier preparation
PHARMA-GRADE SOLVENTS/ MULTI-COMPENDIA-GRADE SOLVENTS
Labelled USP, BP, Ph.Eur., IP, and JP-grade solvents in customized packs
Modern technology and innovative processes to achieve quality through continual improvement
Robust standard operating procedures at every stage production
In-house testing facility
Qualified and trained personnel at every step of operations
Ready-to-audit facility
Documentary support and declarations provided on customers’ request
CONTROLLED RESIDUE, NMRCOMPLIANT BULK SOLVENTS
Residue controlled by multi-purification of solvents below 5ppm Tested by NMR, free residual peaks in aliphatic zone Solvents available in 25L and 200L packs`
PRODUCTS:
Hexane, dichloromethane, ethyl acetate, methanol, and acetone
PRODUCTS FEATURES:
Residue controlled by multi-purification of solvents below 5ppm
Tested by NMR, free residual peaks in alphatic zone.