1The 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.
[Ingredient with Therapeutic value is referred to as Active Pharmaceutical Ingredient (API) and the one without Therapeutic Value but used to complete a Dosage Form is termed as Excipient.]
All Ingredients used in Formulation require Routine Analysis to ascertain the Quality of the Finished Products.
2EFRAC’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.
[EFRACs Pharma Testing Department performs Systematic and Stringent QC Analysis of APIs, Bulk Drugs, Intermediates, Excipients, Finished Products & Packaging Materials. Physical, Chemical, and Microbiological Analyses as per Standardized Validation or Pharmacopoeial Protocols and in conformance with CGMP Quality Standards to effectively ascertain the Quality of the Finished Product.]
Ingredient Testing
• Sulphur Dioxide Estimation • Clarity and Color of Solution • Chemical Analysis Assay (Chemical and Microbiological) • Bacterial Endotoxin Test (BET) • Impurities and Related Substances • Residual Solvents and Organic Volatile Impurities [Volatile Organic Impurities] • TGA Analysis • Melting Point/Range • Boiling Point/Range • Distillation range • Congealing Temperature/Range [Melting Point Range • Boiling Point Range • Distillation Range • Congealing Temperature Range]• Identification • DSC Analysis • Viscosity • Specific Optical Rotation • Particle Size Distribution • Heavy Metals (Quantitative) • Limit Tests (Quantitative Estimation) • Fatty Acid Composition • Microbial Limit Test (MLT) • Nitrogen Estimation • Polymorphism • Sensory Evaluation • Sterility • Steroid Assay • Enantiomeric Purity • Elemental [Elemental Analysis]
• LC-MS-MS (QQQ) • GC- (FID) • GC- (HEADSPACE, ECD, MS) • GC-MS MS (QQQ) • HPLC (FLD, PDA, ELSD, RID) • AAS – (Flame, GTA, VGA) • ICP OES1 [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
• British Pharmacopeia [Pharmacopoeia]
• European Pharmacopeia [Pharmacopoeia]
• Indian Pharmacopeia [Pharmacopoeia]
• Japanese Pharmacopeia [Pharmacopoeia]
• United States Pharmacopeia [Pharmacopoeia]
Drug & Cosmetic 
Microbiological 
Method 
Waste 
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