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Pharmaceutical Water Testing

Water plays a Central Role in the Production of Pharmaceuticals. It is widely used as a Raw Material, Ingredients & Solvents in Processing, Formulation & Manufacturing of Pharmaceutical Ingredients, Intermediates & Finished Products. The most Stringent Quality Requirements apply to Pharmaceutical Water, both as a Product Component and in Industrial Consumption. Physico-chemical and Microbiological Quality Control are essential for Manufacturing in accordance with GMP and are prescribed by Law.

EFRAC has facility for Complete Analysis of Raw Water (Potable water), Purified water, Water for Injection, Water for Hemodialysis as per different Pharmacopoeial and other Regulatory Requirements. EFRAC also provides Service for Water System Validation as per USEPA, WHO, BIS, ICH, cGMP. Apart from the Routine Testing’s in Water, EFRAC also offers Testing of Dioxin, Furans and Dioxin like PCBs in Water.

PARAMETERS

• Physio Chemical Parameters
• Organoleptic Parameters
• Minerals
• Anions and Cations
• Heavy Metals
• VOCs & SVOCs
• Trihalomethane
• Organic & Inorganic Disinfectants
• Halo Acetic Acids
• PAH
• PCB
• Total Organic Carbon (TOC)
• Pesticides (As per IS, EU, FDA, WHO, EPA) • Dioxins and Furans
• All Microbiological Tests (As per IS, EU, FDA, WHO, EPA)
• Radioactive Compounds (Alpha and Beta Emitters)

INSTRUMENTS

• HR GC HRMS • LC-MS/MS • GC- (FID/ECD/TCD/MS) • GC-MS/P&T/HS • HPLC (FLD, PDA, ELSD, RID) • FTIR • AAS – (Flame, GTA, VGA) • ICP OES • ICP MS • IC -CD/AD/UV • UV – Visible Spectrophotometer • TOC Analyzer • CHNS & O Analyzer

METHODS

• British Pharmacopeia • European Pharmacopeia • Indian Pharmacopeia • Japanese Pharmacopeia • United States Pharmacopeia • WHO Guidelines • IS 10500-2012 • IS 4251-1967 • APHA • US FDA BAM • Council Directive 98/83/EC • USEPA