Analytica Chemie Inc. has GMP & GLP compliant, state-of-the art analytical chemistry services laboratory, which is accredited by NABL (ISO/IEC 17025:2005). We offer support in structure elucidation and characterization of small molecules by spectroscopic techniques (such as NMR (both 1D, 2D NMR), Mass, IR, UV etc) and chromatographic techniques (HPLC, GC etc.). We offer analytical services to various pharmaceutical companies in India in accordance with current regulatory requirements.
Analytical Testing Services
Analytical testing of APIs, excipients and formulations for pharmacopeial compliance as per EP, USP, BP and IP
Analytical testing of raw-materials, intermediates, drug substances, fine chemicals, phytochemicals, agrochemicals, pesticides, nutraceuticals and dietary supplements.
Specific analytical services using NMR, HPLC, UHPLC, GC, LC-MS, GC-MS, Polarimetry, IR, UV, elemental analysis etc.
Analytical Method Development and Method Validation
Analytical method development and method validation in accordance with the ICH and regulatory guidelines and other specifications/requirements of the clients.
Purity determination of raw materials, intermediates and APIs by quantitative NMR (QNMR) and by HPLC assay methods using standard compounds.
Isolation and Characterization of Unknown Impurities
Isolation and characterisation of unknown impurities (even at trace levels), metabolites and degradation products from APIs and finished products by utilizing our strong skills in preparative HPLC isolation and structure elucidation by NMR spectroscopic techniques using 1D like 1H, 13C, DEPT, APT, 19F, 15N experiments & 2D experiments like COSY, HSQC, HMBC, NOESY, ROESY, TOCSY, etc.
Short term and long term stability studies (both accelerated and real time) of APIs and finished products
Forced degradation studies (Chemical, Thermal and Photochemical) of APIs and formulations
Extractable and leachable studies
Containers and packing materials
Containers with drugs
Residual Solvent Method Validation
Complete analytical chemistry services for residual solvents estimation, residual metal content (in accordance with the ICH requirements) and genotoxic impurities.