Description

Eptifibatide Non Cyclic Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Eptifibatide. This impurity is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a benchmark in analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Eptifibatide API and its formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure API and drug product purity meets ICH, USP, or EP guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Critical for compiling impurity data in Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development (R&D): Utilized in synthetic chemistry research to understand and optimize the manufacturing process for Eptifibatide.

Basic Information

Product Name	Eptifibatide Non Cyclic Impurity
CAS No.	135900-78-6
Molecular Formula	C35H49N11O9S2
Molecular Weight	832.0 g/mol
Synonyms	Nα-(Mercaptoacetyl)-Nω-(carbamimidoyl)-D-homoarginyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, Disulfide with Nα-(Mercaptoacetyl)-Nω-(carbamimidoyl)-D-homoarginyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide; Eptifibatide Open Chain Impurity; Eptifibatide Linear Impurity; Eptifibatide Reduced Form Impurity; Integrilin Non-Cyclic Impurity; MK-0852 Non Cyclic Impurity; L-Cysteinamide, Nα-(mercaptoacetyl)-Nω-(carbamimidoyl)-D-homoarginyl-L-α-aspartyl-L-tryptophyl-L-prolyl-, (R∗,R∗)-disulfide
EINECS	Contact for details

Quality Control

Every batch of Eptifibatide Non Cyclic Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.