Active Pharmaceutical Ingredient

Phentolamine Mesylate — CAS 65-28-1

Also known as: Regitine (brand); Rogitine (brand); Phentolamine Methanesulfonate

GMP Certified IP / BP / EP / USP Alpha-Adrenergic Blocker / Antihypertensive Aurangabad, India
Phentolamine Mesylate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Phentolamine Mesylate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 65-28-1

Product Overview

Phentolamine Mesylate is a non-selective, reversible alpha-adrenergic receptor blocker used in the management of hypertensive emergencies and pheochromocytoma. Mediocon Inc manufactures this high-purity API at its GMP-certified facility in Aurangabad, Maharashtra, India. It blocks both alpha-1 and alpha-2 adrenoceptors, causing vasodilation and reduction of blood pressure. It is also used intravenously to reverse local anesthesia and in the treatment of erectile dysfunction.

Therapeutic Applications
  • Hypertensive crisis management in pheochromocytoma surgery
  • Prevention and treatment of dermal necrosis from norepinephrine extravasation
  • Reversal of soft tissue anesthesia in dental and oral procedures
  • Erectile dysfunction treatment (intracavernosal injection formulations)

Technical Specifications

ParameterSpecification
CAS Number65-28-1
Molecular FormulaC₁⁷H₁ₙN₃O₄S
Molecular Weight377.46 g/mol
GradeIP / BP / EP / USP
CategoryAlpha-Adrenergic Blocker / Antihypertensive
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 NoPHM/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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