Analytical Services

• API/RM/PM testing ,storage and COA generation.
• Particle size distribution Analysis, testing and measurement, method development and validation by using Malvern Mastersizer 3000
• X-Ray Diffraction Analysis (XRD) investigates crystalline material structure, including atomic arrangement, crystallite size, and imperfections
• XRD Method development along with validation for both identification and quantification with overlays for crystalline material which includes phase composition , structure variations (solid solutions and polymorphs), crystallinity & orientation Non-crystalline periodicity, size and orientation.
• SEM studies by using Hitachi S-3400N model for morphological characteristics, visualization of texture and contamination of materials
• Impurity Characterisation: Development and Validation studies are designed as per USP / for Active pharmaceutical ingredients, intermediates and drug products
• Extractables and leachables: Controlled extraction studies utilizing HPLC, LC-MS, GC-MS, GC-HS-MS and ICP-MS with data interpretation and extractable screening for Pharmaceutical products and potential leachable identification
• Support to product development, GMP Manufacturing analytical support