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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