Active Pharmaceutical Ingredient

Dexamethasone Sodium Phosphate API Manufacturer & Supplier in India

Also known as: DSP; Decadron Phosphate; Dexamethasone 21-phosphate disodium

CAS: 2392-39-4 Corticosteroid IP / BP / USP GMP Certified Aurangabad, Maharashtra, India
Dexamethasone Sodium Phosphate API — Mediocon Inc
Dexamethasone Sodium Phosphate — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 2392-39-4  |  MF: C₂₂H₂₈FNa₂O₈P  |  MW: 516.40 g/mol

Dexamethasone Sodium Phosphate is a high-purity Corticosteroid supplied by Mediocon Inc as an Active Pharmaceutical Ingredient (API) conforming to IP / BP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India, it meets the stringent quality requirements of global pharmaceutical manufacturers.

Dexamethasone Sodium Phosphate is a water-soluble salt of dexamethasone used in parenteral and ophthalmic formulations. It enables rapid onset of action when given intravenously or intramuscularly for emergency and acute care situations.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Injectable anti-inflammatory therapy
  • Ophthalmic and otic preparations
  • Acute allergic reactions and anaphylaxis
  • Shock, sepsis and critical care

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameDexamethasone Sodium Phosphate
Also Known AsDSP; Decadron Phosphate; Dexamethasone 21-phosphate disodium
CAS Number2392-39-4
Molecular FormulaC₂₂H₂₈FNa₂O₈P
Molecular Weight516.40 g/mol
CategoryCorticosteroid
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; soluble in ethanol, chloroform
GradeIP / BP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Dexamethasone Sodium Phosphate (CAS 2392-39-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Dexamethasone Sodium Phosphate is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Dexamethasone Sodium Phosphate API

What is the minimum order quantity for Dexamethasone Sodium Phosphate API?
Mediocon Inc supplies Dexamethasone Sodium Phosphate with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Dexamethasone Sodium Phosphate does Mediocon supply?
We supply Dexamethasone Sodium Phosphate conforming to IP / BP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Dexamethasone Sodium Phosphate API?
Every shipment of Dexamethasone Sodium Phosphate comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Dexamethasone Sodium Phosphate bulk orders?
Standard lead time for Dexamethasone Sodium Phosphate is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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