Description

Tirofiban Impurity (4,4'-Dipyridyl-1,5-Pentane) CAS NO 25382-33-6 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity and intermediate in the synthesis and quality control of Tirofiban Hydrochloride, a potent antiplatelet drug. It is essential for analytical chemists and pharmaceutical manufacturers engaged in method validation, stability studies, and ensuring regulatory compliance for drug substances. The availability of this well-characterized impurity is fundamental for maintaining the safety, efficacy, and quality of the final pharmaceutical product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Tirofiban Hydrochloride active pharmaceutical ingredient (API).
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing and validating chromatographic methods to quantify related substances in drug substances and products.
• Stability Indicating Method: Used in forced degradation studies to monitor the formation of this specific impurity under various stress conditions.
• Process Chemistry & Impurity Profiling: Employed to identify, track, and control this impurity during the synthetic process development and scale-up of Tirofiban.
• Regulatory Compliance & Filing: Necessary for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and qualification data.
• Quality Control (QC) Testing: Serves as a system suitability and identification standard in routine QC release testing of Tirofiban batches.
• Academic & Contract Research: Used in pharmacological and chemical research studying glycoprotein IIb/IIIa receptor antagonists.

Basic Information

Product Name	Tirofiban Impurity (4,4'-Dipyridyl-1,5-Pentane)
CAS No.	25382-33-6
Molecular Formula	C15H18N2
Molecular Weight	226.32 g/mol
Synonyms	1,5-Bis(4-pyridyl)pentane; 4,4'-Dipentylenedipyridine; 4,4'-Trimethylenedipyridine (common misnomer); N,N'-(1,5-Pentanediyl)bis[4-pyridinamine]; Tirofiban Related Compound; Tirofiban Impurity A (in some contexts); AGGR-053; UNII-8V71L5A2D8
EINECS	Contact for details

Quality Control

Every batch of Tirofiban Impurity (4,4'-Dipyridyl-1,5-Pentane) is manufactured and tested under strict quality systems. We provide comprehensive analytical data to support its use as a reference standard, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by advanced chromatographic techniques (HPLC, GC). Certificates of Analysis (COA) detailing batch-specific results are supplied and traceable to primary standards. Our quality commitment ensures compliance with the rigorous standards expected in pharmaceutical impurity sourcing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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