Phentolamine Mesylate: Reference Standard for a Critical Alpha-Blocker Drug

 Phentolamine is a non-selective alpha-adrenergic blocker used in acute, high-stakes clinical settings — from managing hypertensive emergencies caused by catecholamine excess (such as pheochromocytoma) to reversing local anesthetic effects and treating extravasation of vasoconstrictor drugs. Because it's used in emergency and injectable contexts where precision matters most, its salt form — Phentolamine Mesylate — requires a rigorously characterized reference standard to support consistent, compliant manufacturing.

What Is Phentolamine Mesylate?

Phentolamine Mesylate is the methanesulfonate salt of Phentolamine, chemically defined (per EP) as 3-[(4,5-Dihydro-1H-imidazol-2-yl)methyl amino]phenol methanesulfonate. It's the pharmacopeial reference form most commonly required for identity confirmation, potency testing, and impurity profiling during Phentolamine drug product manufacturing.

Key specifications:

  • CAT No: SZ-P010001
  • CAS No: 65-28-1
  • Molecular Formula: C17H19N3O : CH4O3S
  • Molecular Weight: 281.3 : 96.1
  • Related CAS Numbers: 50-60-2 (free base), 73-05-2 (HCl salt), 249607-93-0 (HBr salt)
  • Availability: Synthesis on demand
  • Shipping Condition: Room temperature

Why This Reference Standard Matters

Reference standards like Phentolamine Mesylate are essential wherever regulatory-grade identity and purity confirmation is required. Specifically, it supports:

  • Analytical method development and validation (AMV) — building reliable HPLC/LC-MS methods for identity and assay testing
  • Quality control (QC) testing — confirming batch identity and potency during commercial production
  • ANDA filing support — supplying the authentic reference material regulators expect in submission dossiers
  • Forced degradation studies — characterizing how the compound behaves under stress conditions
  • Impurity identification — anchoring comparison against the parent drug and related impurities during method development

Part of a Broader Phentolamine Impurity Series

SynZeal's Phentolamine Mesylate reference standard sits alongside a fuller impurity portfolio for this API, including EP Impurities A, B, and C, the Phentolamine Keto Analog (USP), and several nitroso-related impurities such as Phentolamine Nitroso Impurity 1 and N-Nitroso Phentolamine EP Impurities B and C — reflecting the heightened industry-wide focus on nitrosamine risk assessment for injectable and emergency-use drugs.

Every product is supplied with detailed characterization data compliant with regulatory guidelines, and traceability against USP or EP pharmacopeial standards can be provided based on feasibility. As with all SynZeal reference materials, it is intended strictly for laboratory, research, and analytical use — not for human consumption.

Explore the Full Catalog

If your lab works with Phentolamine or related alpha-adrenergic blockers, it's worth browsing the full SynZeal product catalog for current stock status across thousands of pharmacopeial and non-pharmacopeial reference standards, metabolites, and nitrosamine-related compounds.

This article is for general informational purposes and does not constitute regulatory or medical advice. This compound is intended strictly for laboratory, research, and analytical use — not for human consumption. Product availability, CAS numbers, and specifications should always be verified directly on the manufacturer's website before ordering.

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