Description

Tirofiban Hydrochloride Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Tirofiban Hydrochloride. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Tirofiban Hydrochloride API batches.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure API specifications are met according to ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Tirofiban Hydrochloride.
• Research & Development: Facilitates chemical research into the synthesis, metabolism, and properties of Tirofiban and related compounds.

Basic Information

Product Name	Tirofiban Hydrochloride Impurity 11
CAS No.	2250244-25-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tirofiban Related Compound 11; Tirofiban Impurity 11; Tirofiban HCl Impurity 11; AGGR-STAT Impurity 11; L-700,462 Impurity; N-(Butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine Hydrochloride Impurity; (2S)-3-(4-Butylsulfonylamino-2-hydroxyphenyl)-2-[[(4-piperidin-4-ylbutoxy)carbonyl]amino]propanoic Acid Hydrochloride Impurity
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Tirofiban Hydrochloride Impurity 11 is characterized using advanced analytical techniques, including HPLC, MS, and NMR, to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are available upon request. Our quality management system supports the needs of cGMP-compliant pharmaceutical manufacturing and research.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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