1. Ingredient Testing - EFRAC | Drug, Food, Gas, Proficiency Testing Laboratory
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    INGREDIENT TESTING

    Pharmaceutical Ingredients are the “Raw Material”, maybe Natural, Semi-Synthetic or Synthetic Chemical Compounds or Biologically Derived Products, which are used for Formulation of Various Dosage Forms. The Ingredients which have Therapeutic value are referred to as Active Pharmaceutical Ingredient (API) and Ingredients that have no Therapeutic Action but are used to formulate a Dosage Form are known as Excipients. All Ingredients used in Formulation require Routine Analysis to ascertain the Quality of the Finished Products.

    EFRAC‘s Pharma Testing wing routinely performs QC Analysis according to CGMP Quality Standards for the APIs, Bulk Drugs, Intermediates, Excipients, Finished Products & Packaging Materials for Systematic and Stringent Physical, Chemical and Microbiological Analysis as per the Standardized Validation or Pharmacopoeial Protocols to ascertain the Quality of the Finished Product.

    EFRAC- ingridient testing
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    Ingredient Testing

    PARAMETERS

    • Assay (Chemical and Microbiological) • Bacterial Endotoxin Test (BET) • Boiling Point/Range • Melting Point / Range • Clarity and Color of Solution • Congealing Temperature/Range • Distillation Range • Elemental Analysis • Enantiomeric Purity • Fatty Acid Composition • Heavy Metals (Quantitative) by AAS, ICP-OES, ICP-MS, ICP-OES • Identification by FT-IR, Chemical Analysis etc. • Impurities and Related Substances • Limit Tests (Quantitative Estimation) • Microbial Limit Test (MLT) • Nitrogen Estimation • Specific Optical Rotation • Particle Size Distribution • Polymorphism • Residual Solvents and Organic Volatile Impurities • Sensory Evaluation • Sterility • Steroid Assay • Sulphur Dioxide Estimation • Viscosity • TGA Analysis • DSC Analysis

    INSTRUMENTS

    • LC-MS-MS (QQQ) • GC- (FID) • GC- (HEADSPACE, ECD, MS) • GC-MS MS (QQQ) • HPLC (FLD, PDA, ELSD, RID) • AAS – (Flame, GTA, VGA) • ICP OES • ICP-MS • TOC Analyzer • UV -Visible Spectrophotometer • Brookfield Viscometer • CHNS & O Analyzer • FT-IR • Ion Chromatograph • Karl-Fisher Autotitrator • TGA • DSC • Particle Size Analyzer

    METHODS

    • Indian Pharmacopoeia
    • British Pharmacopoeia
    • European Pharmacopoeia
    • Japanese Pharmacopoeia
    • United States Pharmacopoeia