Description

Tirofiban Impurity 3 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Tirofiban HCl. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the antiplatelet drug Tirofiban.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Tirofiban API and its formulations.
• Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurity levels during API synthesis and purification.
• Quality Control & Batch Release: Used in routine QC testing to confirm that Tirofiban batches meet stringent pharmacopeial (e.g., USP, EP) or in-house specifications for impurity limits.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data on impurity profiles for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways by identifying and tracking specific process-related impurities.

Basic Information

Product Name	Tirofiban Impurity 3
CAS No.	1346918-32-8
Molecular Formula	C22H36N2O5S
Molecular Weight	440.60 g/mol
Synonyms	N-[4-(Butylsulfonylamino)butyl]-N-(pyridin-4-ylmethyl)-L-tyrosinamide; Tirofiban Related Compound 3; Tirofiban EP Impurity C; Tirofiban USP Impurity; AGGR-3; L-Tyrosine, N-[4-[[(butylamino)sulfonyl]amino]butyl]-N-(4-pyridinylmethyl)-, amide
EINECS	Contact for details

Quality Control

Every batch of Tirofiban Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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