Pharmacopoeias Product Testing : Testing of APIs, raw, intermediate & finished products as per USP, EP, BP, JP, ACS, etc

Testing of Non pharmacopoeias products : Analysis using validated In-house testing method and standard testing method of non-pharmacopoeias products.

Specializes in :

• Residual solvent analysis according to ICH guidelines- Q3 on GC
• Pesticides Residues analysis according to USP, AOAC, EPA on GC and HPLC
• Estimation of trace level heavy metals on ICP
• Testing of Aflatoxins - B1, B2, G1 and G2
• Estimation of Trace level analysis for Ethylene Oxide ( ETO) on GC
• Endotoxin testing using LAL method
• Minerals analysis on ICP
• Vitamins analysis on HPLC
• Herbal identification and standardizations on HPLC, GC, UV also using various chromatographic techniques
• Microbiological evaluations in food, pharmaceuticals and herbal products.

Analytical Method Development : Method development for trace metals analysis on ICP, Mineral analysis on ICP & Vitamin analysis on HPLC, analysis of Standardized Herbal extract using HPLC, UV , column chromatography and TLC and the formulated products.

Analytical Method validation studies: In-house method validation studies according to ICH guidelines Q2B in an efficient and cost effective manner providing with supporting documents, raw data to ensure reliability, consistency and accuracy of data.

Shelf life Studies: Accelerated and Real time stability studies with defined climatic zones according to ICH guidelines Q1, Electronically controlled environmental chambers, forced degradation studies with stimulated conditions to demonstrate and validate stability indicating.

Impurities Profile: Impurities profile studies for potential impurities, degraded products, residual solvents according to ICH guidelines Q3 using validated analytical methods. indicating method.

Formulation Development : Pre formulation, formulation of wide range of high quality solid dosage forms, scale up of pilot batches. Process validation with the supported technology transfer documents and assisting our clients providing with the validated analytical testing method.

• Bio equivalence study : In- vitro dissolution type study
• Nutritional facts labeling : Providing data of Nutritional facts labeling for food products and dietary supplements.