Description

Tirofiban Impurity 15 is a designated impurity standard of the antiplatelet drug Tirofiban, identified by CAS No. 1253789-33-1. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory compliance. It is essential for research and quality assurance laboratories in the pharmaceutical industry to ensure the purity, safety, and efficacy of Tirofiban API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tirofiban Impurity 15 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Serves as a critical component in developing and optimizing HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Release Testing: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions and during shelf-life studies.
• Pharmacopoeial Testing: Supports testing to meet the specifications of pharmacopoeias such as USP, EP, or BP where applicable.

Basic Information

Item	Detail
Product Name	Tirofiban Impurity 15
CAS No.	1253789-33-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Related Compound 15; Tirofiban EP Impurity G; Tirofiban USP Impurity; (3S)-3-[[[4-(4-Cyanophenyl)-4-piperidinyl]oxy]acetyl]amino]-5-[[(3S)-1-oxo-3-(phenylsulfonylamino)propyl]amino]-4-oxopentanoic Acid (Potential IUPAC); AGGR-STAT Impurity; MK-383 Impurity; L-700,462 Impurity
EINECS	Contact for details

Quality Control

Every batch of Tirofiban Impurity 15 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assay by HPLC, and control of related substances and residual solvents. A Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment, ensuring traceability and compliance with cGMP standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the material from moisture absorption.

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)	Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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