Active Pharmaceutical Ingredient

Pemirolast Potassium — CAS 100299-08-9

Also known as: TBX Potassium Salt; Alamast (brand)

GMP Certified IP / BP / EP / USP Antiallergic / Mast Cell Stabilizer Aurangabad, India
Pemirolast Potassium API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pemirolast Potassium IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 100299-08-9

Product Overview

Pemirolast Potassium is the potassium salt form of Pemirolast, widely used as an ophthalmic antiallergic agent. Mediocon Inc manufactures this GMP-certified API at its Aurangabad, Maharashtra facility. The compound acts by preventing mast cell degranulation and blocking histamine release, providing effective relief in allergic eye diseases. It is formulated primarily as ophthalmic drops for allergic conjunctivitis.

Therapeutic Applications
  • Ophthalmic antiallergic therapy for allergic conjunctivitis
  • Prevention of itching associated with allergic conjunctivitis
  • Mast cell stabilization in ocular mucosa
  • Seasonal and perennial ocular allergic conditions

Technical Specifications

ParameterSpecification
CAS Number100299-08-9
Molecular FormulaC₁₀H₇KN₆O
Molecular Weight266.30 g/mol
GradeIP / BP / EP / USP
CategoryAntiallergic / Mast Cell Stabilizer
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPMPK/24032026
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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