Description

Tirofiban Impurity 30 is a specified impurity and reference standard used in the analytical profiling and quality control of the antiplatelet drug Tirofiban. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and routine batch testing within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tirofiban Impurity 30 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Assurance: Employed in routine quality control laboratories to monitor and control impurity levels during Tirofiban API synthesis and manufacturing processes.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Tirofiban.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and qualification data.
• Process Chemistry Research: Aids chemists in optimizing synthesis routes to minimize the formation of this specific impurity.

Basic Information

Product Name	Tirofiban Impurity 30
CAS No.	88940-35-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[4-(4-Piperidinyl)butyl]-N-(phenylsulfonyl)-L-tyrosinamide; Tirofiban Related Compound 30; Tirofiban EP Impurity G; AGGR-30; Tirofiban Sulfonamide Impurity; (2S)-2-[[(4-Pentylphenyl)sulfonyl]amino]-3-(4-hydroxyphenyl)-N-(4-piperidin-1-ylbutyl)propanamide
EINECS	Contact for details

Quality Control

Our Tirofiban Impurity 30 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC purity, NMR, and MS for full characterization. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

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