Description

Tirofiban Impurity 19 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Tirofiban. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the development and validation of chromatographic methods for impurity identification and quantification. Professionals in pharmaceutical R&D and quality assurance rely on this high-purity standard to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration and validation of analytical methods (e.g., HPLC, LC-MS) in Tirofiban API and drug product testing.
• Quality Control & Assurance: Used in-house by API manufacturers to monitor and control impurity levels during production, ensuring batch-to-batch consistency.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Method Development & Validation: A key component in developing, optimizing, and validating stability-indicating assay methods for Tirofiban.
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability studies of Tirofiban formulations.
• Research & Development: Used in academic and industrial research to study the degradation pathways and metabolism of Tirofiban.

Basic Information

Item	Detail
Product Name	Tirofiban Impurity 19
CAS No.	158808-75-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Related Compound 19; Tirofiban EP Impurity H; Tirofiban USP Impurity; N-[4-(4-Piperidinyl)butyl]-3-pyridinecarboxamide; L-Tyrosine, N-[4-(4-piperidinyl)butyl]-, (αS)-; (S)-N-(4-(Piperidin-4-yl)butyl)tyrosinamide; A degradation product of Tirofiban
EINECS	Contact for details

Quality Control

Every batch of Tirofiban Impurity 19 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.