Active Pharmaceutical Ingredient

Metadoxine API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 74536-44-0 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Metadoxine API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Metadoxine API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 74536-44-0 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Metadoxine API

Metadoxine is a pharmaceutical-grade active ingredient composed of pyridoxine (vitamin B6) and L-pyroglutamic acid (L-pidolic acid) in a 1:1 association. It is also known as Pyridoxine Pyroglutamate, Metadoxil, Metadoxin, Metasin and Metadixine. MEDIOCON INC supplies Metadoxine for pharmaceutical formulation, analytical development, research and bulk API requirements.

Metadoxine has the molecular formula C₁₃H₁₈N₂O₆, CAS number 74536-44-0, and molecular weight 298.29 g/mol. PubChem identifies Metadoxine as a combination of pyridoxine and L-pyroglutamic acid and lists 74536-44-0 as its CAS number. The FDA substance database identifies the same CAS number and FDA UNII EJQ7M98H5J.

Metadoxine is generally described as a white to off-white crystalline powder or solid. Current pharmaceutical and research suppliers report purity specifications of approximately 98% minimum, with some pharmaceutical-grade listings reporting 99% or higher HPLC purity.

Metadoxine has been used in pharmaceutical preparations associated with liver functional disorders and alcohol-related conditions. PubChem assigns Metadoxine the WHO ATC classification A05BA09, under liver therapy/lipotropics, and identifies its pharmacological classification as an alcohol-deterrent substance.

Metadoxine is a water-soluble pharmaceutical compound and is reported to be freely soluble in water in pharmaceutical-grade supplier specifications. Other chemical references report limited solubility in solvents such as DMSO and methanol, depending on the specific material and test conditions.

Available pharmaceutical-grade specifications report assay/purity ≥98.0%, loss on drying ≤0.5–1.0%, and heavy metals ≤10 ppm. A current supplier specification also reports residue on ignition ≤0.2%. These are supplier specifications and should be confirmed against the actual batch COA rather than represented as a universal pharmacopoeial requirement.

MEDIOCON INC supplies Metadoxine with applicable product documentation including Certificate of Analysis (COA), MSDS/SDS and technical specifications, according to the applicable product specification and customer requirements.

Metadoxine should be stored in a tightly closed container in a cool, dry and light-protected environment. Current supplier references commonly recommend 2–8°C storage, while some research suppliers recommend lower temperatures for long-term storage

Product Specifications

Product NameMetadoxine API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number74536-44-0
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to Off-White Crystalline Powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Loss on DryingNMT 0.5%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.0
Individual Impurity1.0%
Total Impurities1.0%
Water ContentNMT 1.0%
Melting Point102°C – 104°C
SolubilityFreely soluble in water

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 Metadoxine API Manufacturer & Supplier in India | MEDIOCON INC (CAS 74536-44-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Metadoxine API Manufacturer & Supplier in India | MEDIOCON INC 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Metadoxine API Manufacturer & Supplier in India | MEDIOCON INC

What is Metadoxine?
Metadoxine is a pharmaceutical compound consisting of pyridoxine and L-pyroglutamic acid in a 1:1 association, also known as pyridoxine pyroglutamate.
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