Active Pharmaceutical Ingredient

Sodium Oxybate — CAS 502-85-2

Also known as: GHB sodium salt; Xyrem

GMP Certified IP / BP / EP / USP CNS Depressant / Narcolepsy Agent Aurangabad, India
Sodium Oxybate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sodium Oxybate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 502-85-2

Product Overview

Sodium Oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), a naturally occurring CNS depressant and metabolite of GABA. It is indicated for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. Mediocon Inc manufactures pharmaceutical-grade Sodium Oxybate API at its GMP-certified Aurangabad facility.

Therapeutic Applications
  • Narcolepsy with cataplexy
  • Excessive daytime sleepiness
  • CNS depressant therapy
  • Sleep disorder management

Technical Specifications

ParameterSpecification
CAS Number502-85-2
Molecular FormulaC₄H₇NaO₃
Molecular Weight126.09 g/mol
GradeIP / BP / EP / USP
CategoryCNS Depressant / Narcolepsy Agent
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
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 / EP / 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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