Description

Bivalirudin Impurity CAS NO 72378-50-8 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Bivalirudin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in API synthesis, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Bivalirudin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and compliance check to meet pharmacopeial standards (e.g., USP, EP, ICH Q3A/B) for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions to establish drug shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA/ANDA).
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Bivalirudin Impurity
CAS No.	72378-50-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bivalirudin Related Compound; Bivalirudin Degradant; Bivalirudin Process Impurity; Bivalirudin Analog; (D-Phe)-Pro-Arg-Pro-Gly-Gly-Gly-Gly-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu; Hirulog Impurity; Synthetic Thrombin Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Bivalirudin Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to ensure long-term stability. Avoid repeated opening of the primary container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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