Description

Tirofiban Impurity 50 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Tirofiban hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily used by professionals in pharmaceutical R&D, quality assurance, and contract research organizations (CROs) for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Tirofiban API and its drug products.
• Analytical Method Development: Used in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Pharmacopoeial Testing: Supports testing procedures aligned with standards from USP, EP, and other pharmacopoeias.

Basic Information

Product Name	Tirofiban Impurity 50
CAS No.	151414-73-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Related Compound 50; Tirofiban Impurity; Tirofiban EP Impurity; Tirofiban USP Impurity; N-[Butylsulfonyl]-O-[4-(4-piperidinyl)butyl]-L-tyrosine; (2S)-3-(4-Butylsulfonylamino-2-hydroxyphenyl)-2-[[(4-piperidin-1-ylbutyl)amino]carbonylamino]propanoic acid
EINECS	Contact for details

Quality Control

Every batch of Tirofiban Impurity 50 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the exacting standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, chromatographic profile, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, consider storage at 2-8°C. The container should be kept securely sealed in a cool, well-ventilated area away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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