Description

Tirofiban Hydrochloride Monohydrate is a high-purity, non-peptide glycoprotein IIb/IIIa receptor antagonist used as an active pharmaceutical ingredient (API). It is critical for the formulation of antiplatelet medications that prevent thrombotic complications during percutaneous coronary interventions. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for acute coronary syndrome and related cardiovascular conditions. Consistent quality and reliable supply are paramount for ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical API: Primary use as the active ingredient in injectable antiplatelet drugs for acute coronary syndrome.
• Cardiovascular Research: A key reference standard and tool compound for studying platelet aggregation and thrombosis mechanisms in vitro.
• Drug Formulation Development: Used in the R&D of new parenteral dosage forms, including lyophilized powders and sterile solutions.
• Generic Drug Manufacturing: Sourcing of API for the production of bioequivalent versions of branded antiplatelet therapies.
• Clinical Trial Material: Supply of GMP-grade material for Phase I-III clinical studies of new cardiovascular therapeutics.
• Analytical Standard: Serves as a high-purity standard for HPLC, LC-MS, and other analytical method development and validation in QC laboratories.

Basic Information

Product Name	Tirofiban Hydrochloride Monohydrate
CAS No.	142373-60-2
Molecular Formula	C22H36N2O5S • HCl • H2O
Molecular Weight	495.06 g/mol
Synonyms	Tirofiban HCl Monohydrate; MK-383; L-700,462; Aggrastat (brand name); N-(Butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate; (2S)-2-[[[4-(4-Piperidinyl)butoxy]carbonyl]amino]-3-(4-[[(butylsulfonyl)amino]methyl]phenyl)propanoic acid hydrochloride monohydrate
EINECS	Contact for details

Quality Control

Our Tirofiban Hydrochloride Monohydrate is manufactured and tested under strict quality systems. We provide material suitable for pharmaceutical applications, with testing typically aligned with pharmacopeial standards. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 4.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Specific Rotation	Contact for details
Microbiological Enumeration	Meets Ph. Eur. 2.6.12/2.6.13 criteria

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.