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PREGABALIN /IP/USP/EP/BP

PREGABALIN /IP/USP/EP/BP

PREGABALIN /IP/USP/EP/BP

Price 5000 INR
Unit of Measure Gallon/Gallons
Unit of Price Gallon/Gallons

Pregabalin IP/USP/EP/BP refers to the same active pharmaceutical ingredient Pregabalin produced and tested according to the standards set by different official pharmacopeias: Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP). While the chemical structure and therapeutic function of Pregabalin remain the same across all standards, each pharmacopeia outlines specific criteria for identity, purity, strength, impurities, and analytical testing methods. These variations are designed to meet the regulatory requirements of different regions: IP for India, USP for the United States, EP for European Union countries, and BP for the United Kingdom. Manufacturers often produce multi-compendial Pregabalin to comply with global market demands, ensuring the product meets the distinct quality and regulatory standards of each region.

Key SpecificationValue
Product NamePregabalin
Chemical FormulaC8H17NO2
CAS Number192239-29-4
Molecular Weight (g/mol)159.23
Physical AppearanceWhite to off-white crystalline powder
Purity (Assay)≥99.0%
SolubilitySparingly soluble in water
Melting Point (°C)194-198
Particle Size≤ 100 microns
Water Content ≤ 0.5%
Residue on Ignition ≤ 0.1%
Heavy Metals (as Pb) (ppm)≤ 20
Microbial Limit<1000 CFU/g
Storage ConditionsStore at room temperature, protect from light
Packaging Available1 kg, 5 kg, 25 kg bags
GradeIP, USP, EP, BP
ApplicationPharmaceutical Intermediate, API
Density (g/cm³)1.05
Refractive Index1.49