Description

Tirofiban Impurity 14 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Tirofiban HCl. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Tirofiban Hydrochloride API.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately quantify related substances in drug substances and products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity identification and characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Tirofiban formulations.
• Research & Development: Used in process chemistry R&D to understand and control the formation of this impurity during the synthesis of Tirofiban.

Basic Information

Product Name	Tirofiban Impurity 14
CAS No.	1103300-75-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[4-(4-Piperidinyl)butyl]-N-(phenylsulfonyl)-L-tyrosinamide; Tirofiban Related Compound; Tirofiban EP Impurity; Tirofiban USP Impurity; AGGR-14; Tirofiban Sulfonamide Impurity
EINECS	Contact for details

Quality Control

Our Tirofiban Impurity 14 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data 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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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