Description

Tirofiban Hydrochloride Monohydrate is a potent, non-peptide glycoprotein IIb/IIIa receptor antagonist used as an antiplatelet agent. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of injectable solutions used in acute coronary syndrome management. It is essential for pharmaceutical manufacturers and research institutions developing or producing antithrombotic therapies. The compound is supplied as a monohydrate salt form to ensure stability and consistent performance in final drug products.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of injectable antiplatelet medications.
• Acute Coronary Syndrome (ACS) Treatment: Formulated for use in patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) to prevent cardiac ischemic events.
• Percutaneous Coronary Intervention (PCI): Used as an adjunct therapy to prevent thrombosis during and after coronary angioplasty procedures.
• Biomedical Research: Valuable reference standard and tool compound for studying platelet aggregation, thrombosis mechanisms, and glycoprotein IIb/IIIa receptor function.
• Generic Drug Development: Serves as the key component for companies developing bioequivalent versions of branded tirofiban products.
• Hospital Pharmacy Compounding: Used in specialized settings for preparing patient-specific formulations where required.

Basic Information

Item	Details
Product Name	Tirofiban Hydrochloride Monohydrate
CAS No.	150915-40-5
Molecular Formula	C22H36N2O5S · HCl · H2O
Molecular Weight	495.06 g/mol
Synonyms	Tirofiban HCl Monohydrate; L-Tyrosine, N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-, monohydrochloride, monohydrate; MK-383; Aggrastat; (S)-N-(Butylsulfonyl)-4-[4-(4-piperidinyl)butoxy]phenylalanine Monohydrochloride Monohydrate; Tirofiban (hydrochloride monohydrate); GP IIb/IIIa Inhibitor Tirofiban HCl Monohydrate
EINECS	Contact for details

Quality Control

Our Tirofiban Hydrochloride Monohydrate is manufactured under strict quality management systems. It is typically produced to meet pharmaceutical grade standards, with specifications aligned with major pharmacopoeial requirements. Each batch undergoes comprehensive analytical testing, including identity, purity, and impurity profile analysis. Certificates of Analysis (COA) documenting all test results are available upon request to ensure full traceability and compliance for your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider conditions that minimize exposure to humidity and temperature fluctuations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 4.5%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details
pH (in solution)	Contact for details

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