Active Pharmaceutical Ingredient

Polysorbate 80 GMP Grade Manufacturer and Supplier in India

CAS: 9005-65-6 GMP Certified Aurangabad, Maharashtra, India
Polysorbate 80 GMP Grade Manufacturer and Supplier in India — Mediocon Inc
Polysorbate 80 GMP Grade Manufacturer and Supplier in India

Product Overview

CAS No: 9005-65-6

MEDIOCON INC offers Polysorbate 80 at GMP level, a pharmaceutical-grade nonionic surfactant and excipient widely used as an emulsifying, solubilizing, dispersing and stabilizing agent. Also known as Polyoxyethylene (20) Sorbitan Monooleate, Polysorbate 80 is composed primarily of partial esters of fatty acids, mainly oleic acid, with sorbitol and its anhydrides ethoxylated with approximately 20 moles of ethylene oxide.

GMP-level Polysorbate 80 is suitable for pharmaceutical, biotechnology, nutraceutical and other regulated formulation applications where consistent quality, controlled impurities and reliable batch-to-batch performance are important. It is commonly used in formulations as a surfactant, emulsifier, solubilizer and stabilizer.

MEDIOCON INC supplies Polysorbate 80 for pharmaceutical and industrial formulation requirements, with product specifications and documentation according to the applicable grade. Pharmacopeial specifications for Polysorbate 80 include parameters such as acid value, hydroxyl value, peroxide value, saponification value, fatty-acid composition, ethylene oxide, dioxane, water and residue on ignition.

The product can be supplied with applicable quality documentation such as Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), specification sheet, GMP-related documentation and other technical documents, subject to the actual product grade and customer requirements.

For bulk quantities, technical specifications, GMP-level Polysorbate 80 and commercial supply requirements, contact MEDIOCON INC for product availability and documentation.

Product Specifications

Product NamePolysorbate 80 GMP Grade Manufacturer and Supplier in India
CAS Number9005-65-6

Analytical Specifications

ParameterSpecification
Residue on IgnitionNMT 0.25%
Heavy MetalsNMT 10 ppm
Water ContentNMT 3.0%
SolubilityVery 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 Polysorbate 80 GMP Grade Manufacturer and Supplier in India (CAS 9005-65-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Polysorbate 80 GMP Grade Manufacturer and Supplier in India 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 — Polysorbate 80 GMP Grade Manufacturer and Supplier in India

What is Polysorbate 80?
Polysorbate 80 is a nonionic surfactant and pharmaceutical excipient composed primarily of partial esters of fatty acids, mainly oleic acid, with sorbitol and its anhydrides ethoxylated with approximately 20 moles of ethylene oxide.
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