Description

Tirofiban Impurity 61 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and analytical validation of Tirofiban, an antiplatelet medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity and safety. The availability of this well-characterized impurity is essential for method development, stability studies, and meeting stringent regulatory compliance standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tirofiban Impurity 61 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Tirofiban drug substance and drug products.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Quality Control & Assurance: A critical tool for in-house QC laboratories to establish specification limits and ensure batch-to-batch consistency of Tirofiban.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry R&D to understand and mitigate the formation pathways of this impurity during the manufacturing process.

Basic Information

Item	Detail
Product Name	Tirofiban Impurity 61
CAS No.	1838627-40-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Related Compound 61; Tirofiban EP Impurity G; Tirofiban USP Impurity; AGGR-61; N-[Butylsulfonyl]-O-[4-(4-piperidinyl)butyl]-L-tyrosine; (2S)-3-(4-Butylsulfonylamino-2-hydroxyphenyl)-2-[[(4-piperidin-4-ylbutyl)amino]carbonylamino]propanoic acid; Tirofiban Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Tirofiban Impurity 61 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) detailing all test results and methods is provided with each shipment to support your regulatory and quality requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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