Our cGMP-compliant analytical centre is well-equipped with state-of-art instruments to support formulation development. 21 CFR part 11 compliant software with automated report generation. We offer analytical support services for oral solids, liquids, creams, ointments and sterile injectables for the following:

• Analytical Method Development, Validation and Transfer

• Identification, Quantification, Potency Assessment and Content Uniformity

• Lot Release and Stability Assessment for Development Batches

• Process Contaminants, Excipients, Impurities and Degradation Products

• Method development, validation, and testing of Particle size for API’s, excipients, and Finished products

• Method development, validation, and testing of Elemental impurities (by ICP-MS) for API’s and raw materials

• Residual Solvents Analysis in API & Formulations on GCHS

• Pharmacopeia Analysis

• Particle Size Distribution

• Comprehensive dissolution test as per USP & ICH Q4B (R2)

• ICH Stability studies

• Computerized systems: HPLCs and GC connected to server network system Chromeleon and ICP-MS connected to Qtegra