Active Pharmaceutical Ingredient

Olopatadine Hydrochloride — CAS 140462-76-6

Also known as: Olopatadine HCl; KW-4679 HCl; Patanol HCl

GMP Certified IP / BP / EP / USP Antihistamine / Mast Cell Stabilizer (HCl Salt) Aurangabad, India
Olopatadine Hydrochloride API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Olopatadine Hydrochloride IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 140462-76-6

Product Overview

Olopatadine Hydrochloride is a high-purity Active Pharmaceutical Ingredient (API) classified as a Antihistamine / Mast Cell Stabilizer (HCl Salt). Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 140462-76-6.

Therapeutic Applications
  • Allergic conjunctivitis (ophthalmic drops)
  • Seasonal and perennial allergic rhinitis
  • Ocular pruritus management
  • Antihistamine ophthalmic formulations
  • Combination allergy products

Technical Specifications

ParameterSpecification
CAS Number140462-76-6
Molecular FormulaC21H23NO3 · HCl
Molecular Weight373.87 g/mol
GradeIP / BP / EP / USP
CategoryAntihistamine / Mast Cell Stabilizer (HCl Salt)
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water; soluble in methanol
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 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 / 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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