Description

Tirofiban Hydrochloride Impurity 6 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 by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Tirofiban Hydrochloride API.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Aids in identifying and tracking the formation of this impurity under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve manufacturing processes for Tirofiban.

Basic Information

Product Name	Tirofiban Hydrochloride Impurity 6
CAS No.	2250244-31-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Related Compound 6; Tirofiban HCl Impurity 6; Tirofiban Impurity F; Tirofiban EP Impurity F; Tirofiban USP Impurity; N-[Butylsulfonyl]-O-[4-(4-piperidinyl)butyl]-L-tyrosine Hydrochloride Impurity; (2S)-3-(4-Butylsulfonylphenyl)-2-[[4-(4-piperidin-1-ylbutoxy)phenyl]methyl]propanoic Acid Hydrochloride Impurity
EINECS	Contact for details

Quality Control

Our Tirofiban Hydrochloride Impurity 6 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant specifications. Certificates are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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