Description

Tirofiban Hydrochloride Monohydrate Impurity 7 is a designated chemical reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Tirofiban. This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Tirofiban Hydrochloride Monohydrate drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch analysis to ensure drug substance and product compliance with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development (R&D): Used in synthetic chemistry research to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Tirofiban Hydrochloride Monohydrate Impurity 7
CAS No.	2250244-28-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Impurity 7; Tirofiban Related Compound 7; Tirofiban HCl Monohydrate Impurity 7; AGGR-7; N-Butylsulfonyl-L-tyrosyl-N-(butylsulfonyl)-O-[4-(piperidin-4-yl)butyl]-L-tyrosinamide Hydrochloride Monohydrate (proposed); L-Tyrosine, N-[(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-, N2-[(butylsulfonyl)-L-tyrosyl]-, hydrochloride, monohydrate (isomeric)
EINECS	Contact for details

Quality Control

Our Tirofiban Hydrochloride Monohydrate Impurity 7 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 pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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) and must be kept under dry conditions to maintain stability and purity.

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)	Contact for details
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.