Formulation Drug Testing

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FORMULATION DRUG TESTING

The Pharmaceutical Formulation Process involves the Constitution of Different Chemical Substances including Active Drugs to produce the Final Medicinal Product. The Dosage Form or Formulation varies according to the Route of Administration.

Enteral or Oral: Tablet, Capsule, Oral Liquid, Oral Powder
Parental: Intravenous, Intraarterial, Intraosseous Infusion, Intra-Muscular, Subcutaneous, Intrathecal, Intracerebroventricular, Rectal
Topical: Epicutaneous (Cream, Lotion, Ointment, Paste), Inhalational, Ophthalmic & Otic Products, Transdermal Patches

EFRAC’s Expert Scientists determine the Quality, Purity, and Stability of Finished products in accordance with Pharmacopoeial Monographs (EP, BP, USP, and JP) and/or to Client specified Requirements. This enables the Products to cater to the Regulatory Requirements of National and International Markets.

Formulation Drug 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 • Identification by FT-IR, Chemical Analysis • Impurities and Related Substances • Limit Tests (Quantitative Estimation) • Microbial Limit Test (MLT ) Nitrogen Estimation • Specific Optical Rotation • Particle Size Distribution • Polymorphism • Content of Active Ingredient • Deposition of the Emitted Dose • Description • Disintegration Test • Dissolution Study • Osmolarity • Friability Testing • Uniformity of Content/Uniformity of Dosage Units • 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- (HEAD SPACE, 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 Analysis