Built on GxP principles Periodic process audits & internal quality checks Regular training of staff on quality systems Implementation of quality systems in compliance with cGMP, GLP,open lab 2.1 (Agilent technologies) All GMP systems enabled with audit trials meeting 21 …
All the Computerized systems for release testing & methodvalidation are compliant to 21 CFR part 11 Audit trials are enabled for every analysis either R&D or ReleaseTesting All the changes are noted with date and time stamps, along withversion control …
Extensive range of chromatography methods (LCMS, GC, HPLC &ICP) Identification Technologies (UV, MS, RI, FID, DAD etc.) Stability indicating assay or related substance techniques for DS &DP Dissolution analysis, organic volatile impurities Preservatives & Antioxidants Enantiomers Separation Cleaning Validation Method …
Analytical Testing For Various Dosage Forms (Topical, Ophthalmic,Oral, Nasal & Complex Injectables Etc.) Physicochemical Profiling (pH Solubility Studies, Wet Analysis Etc.) Chromatographic Analysis (HPLC With UV, PDA, RI ,IC & GC With FID) Spectroscopic Analysis (UV, MS, IR) Dissolution Studies …
Controlled extraction studies utilizing HPLC, LC-MS,GC-MS, GC-HSMS& ICP-MS with data interpretation & extractable screening forboth organic compounds & inorganic elements Determination of AET (analytical evaluation threshold) & SCT(safety concern threshold). Development & validation of analytical methods for potentialleachable identification & …
Intact Mass – Non reduced Intact Mass – Reduced Intact Mass – Deglycosylated Disulfide Linkage analysis Leachable monitoring during shelf life study & routine extractable testing Peptide Mass fingerprinting N-linked Oligosaccharide Analysis Any other specific requirements
In Vitro Drug Release Test (IVRT) Method Development, Validation and testing services. Full compliance with SUPAC-SS (as per FDA) and USP Generalchapter <1724> Guidance.In Vitro Skin Permeation Test (IVPT) using Human cadaver skin Method development, Validation and testing services Pilot …
Genotoxic Impurities By LC-MS & GC-MS. Organic Volatile Impurities As Per ICH Guidelines. Content By LC-MS & GC-MS. Elemental Impurities By ICP-MS As Per USP<232>, <233> & ICH Q3D. Non-chromophoric Compounds By Using RI & MS. Metal Speciation Studies Using …
Q1/Q2 Sameness Q3 Microstructural sameness Viscosity / Thixotrpic Profiling Particle size similarity profiling As per USFDA guidance, characterisation for all types of Dispersesystems such as emulsions (nano and micro), suspensions (nano andmicro), liposomes, microsphere, Iron colloids etc for Ophthalmic,Topicals, Otic …