Description

Tirofiban Impurity 9 is a specified impurity of the antiplatelet drug Tirofiban Hydrochloride, identified by CAS No. 2250244-30-3. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance and drug product manufacturing. It is an essential material for analytical method development, validation, and stability studies, primarily serving pharmaceutical companies, contract research organizations (CROs), and quality control laboratories focused on cardiovascular drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Tirofiban Hydrochloride and related drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Employed as a system suitability and identification standard in the routine QC testing of active pharmaceutical ingredients (APIs) and finished dosage forms to ensure compliance with ICH guidelines.
• Stability Studies: Aids in monitoring the formation and levels of this specific impurity under various stress conditions (e.g., heat, humidity, light) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for impurity identification and qualification reports required for regulatory filings (e.g., FDA, EMA).
• Research & Process Chemistry: Used to study the formation pathway of this impurity, aiding in the optimization of synthesis and purification processes to minimize its presence.

Basic Information

Item	Details
Product Name	Tirofiban Impurity 9
CAS No.	2250244-30-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Related Compound 9; Tirofiban EP Impurity J; Tirofiban USP Impurity; N-[4-(4-Piperidinyl)butyl]-3-[[4-(4-pyridinyl)butyl]sulfonyl]propanamide Impurity; AGGR-STAT Impurity; MK-383 Impurity; L-700,462 Impurity; (S)-N-(Butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine Impurity
EINECS	Contact for details

Quality Control

Our Tirofiban Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by techniques such as IR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and relevant ICH guidelines (Q3A, Q6A) for impurities in new drug substances.

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 inert conditions or in a desiccator to prevent degradation. The container should be kept tightly sealed when not in use.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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