Formulation Drug Testing

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FORMULATION DRUG TESTING

Pharmaceutical Formulation is the Process in which Different Chemical Substances including Active Drugs are formulated to produce a 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 [Intra-arterial], Intraosseous Infusion, Intra-Muscular, Subcutaneous, Intrathecal, Intracerebroventricular, Rectal
Topical: Epicutaneous (Cream, Lotion, Ointment, Paste), Inhalational, Ophthalmic & Otic Products, Transdermal Patches

¹At EFRAC our Expert Group of Scientists can determine the Quality, Purity, and Stability of your Finished products in accordance with Pharmacopoeial Monographs (EP, BP, USP, and JP) and/or to Client. EFRAC specifies to cater the Regulatory Requirements of both the Domestic as well as Export Markets.

[EFRACs Expert Group of Scientists determines whether the Quality, Purity, and Stability of the Client’s Finished product conforms to the Regulatory Standards -National and International Export Markets as applicable, in accordance with Pharmacopoeial Monographs (EP, BP, USP, and JP).]

Formulation Drug Testing

PARAMETERS

• 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 Analysis

INSTRUMENTS

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

METHODS

• British Pharmacopeia [Pharmacopoeia]
• European Pharmacopeia [Pharmacopoeia]
• Indian Pharmacopeia [Pharmacopoeia]
• Japanese Pharmacopeia [Pharmacopoeia]
• United States Pharmacopeia [Pharmacopoeia]