Active Pharmaceutical Ingredient

Olopatadine — CAS 113806-05-6

Also known as: Patanol; Pataday; KW-4679

GMP Certified IP / BP / EP / USP Antihistamine / Mast Cell Stabilizer Aurangabad, India
Olopatadine API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Olopatadine IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 113806-05-6

Product Overview

Olopatadine is a high-purity Active Pharmaceutical Ingredient (API) classified as a Antihistamine / Mast Cell Stabilizer. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 113806-05-6.

Therapeutic Applications
  • Allergic conjunctivitis treatment
  • Seasonal allergic rhinitis
  • Ophthalmic allergic reactions
  • Mast cell stabilization in allergic disorders
  • Antihistamine formulations (ophthalmic and nasal)

Technical Specifications

ParameterSpecification
CAS Number113806-05-6
Molecular FormulaC21H23NO3
Molecular Weight337.41 g/mol
GradeIP / BP / EP / USP
CategoryAntihistamine / Mast Cell Stabilizer
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; freely soluble in 0.1 N HCl
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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