Active Pharmaceutical Ingredient

Parecoxib Sodium — CAS 198470-85-8

Also known as: Dynastat (brand); Sodium parecoxib

GMP Certified IP / BP / USP COX-2 Inhibitor / NSAID / Parenteral Analgesic Aurangabad, India
Parecoxib Sodium API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Parecoxib Sodium IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 198470-85-8

Product Overview

Parecoxib Sodium is the sodium salt form of parecoxib, a selective COX-2 inhibitor prodrug. It is formulated for parenteral administration and used for the short-term management of acute postoperative pain. Mediocon Inc manufactures this API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • IV/IM parenteral treatment of acute postoperative pain
  • Perioperative pain management as part of multimodal analgesia
  • Post-surgical pain after cardiac, orthopedic and general surgery
  • Opioid-sparing analgesic therapy in the perioperative setting

Technical Specifications

ParameterSpecification
CAS Number198470-85-8
Molecular FormulaC19H19NNaO6S
Molecular Weight399.41 g/mol
GradeIP / BP / USP
CategoryCOX-2 Inhibitor / NSAID / Parenteral Analgesic
AppearanceWhite to off-white, crystalline powder
SolubilityPractically insoluble in water, freely soluble in methanol and soluble in ethanol
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPRX/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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