Description

Tirofiban Impurity 12 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

• Primary use as a pharmaceutical reference standard for Tirofiban Hydrochloride.
• Critical component in analytical method development and validation (HPLC, LC-MS).
• Used for impurity identification and quantification to comply with ICH guidelines.
• Essential for quality control and batch release in API manufacturing.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity characterization data.
• Utilized in stability studies to monitor impurity profiles over time.
• Serves as a system suitability component in pharmacopeial testing.

Basic Information

Product Name	Tirofiban Impurity 12
CAS No.	721444-72-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Related Compound 12; Tirofiban EP Impurity J; Tirofiban USP Impurity; N-[4-(4-Piperidinyl)butyl]-N-(phenylsulfonyl)-L-tyrosyl-L-proline; (2S)-2-[[(2S)-1-[[4-(4-Piperidin-1-ylbutyl)phenyl]sulfonyl]pyrrolidine-2-carbonyl]amino]-3-(4-hydroxyphenyl)propanoic acid; AGGR-12; Tirofiban Sulfone Impurity
EINECS	Contact for details

Quality Control

Our Tirofiban Impurity 12 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized and tested using validated analytical methods, including HPLC, NMR, and MS, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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