Description

Eptifibatide impurity 3/Deamidated Eptifibatide Impurity/(3R,11S,17S,20S,25aS)-20-((1H-indol-3-yl)Methyl)-17-(carboxymethyl)-11-(4-guanidinobutyl)-1,9,12,15,18,21-hexaoxodocosahydro-1H-pyrrolo[2,1-g][1,2,5,8,11,14,17,20]dithiahexaazacyclotricosine-3-carbo is a critical process-related impurity of the antiplatelet drug Eptifibatide, a cyclic heptapeptide. This compound is essential for pharmaceutical quality control and regulatory compliance, serving as a reference standard for method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments involved in the synthesis, purification, and quality assurance of Eptifibatide API and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of deamidated Eptifibatide in Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during drug development and manufacturing.
• Process Chemistry Research: Employed in studying degradation pathways and optimizing synthesis conditions to minimize the formation of this specific impurity.
• Regulatory Documentation: Supports the filing of regulatory dossiers (e.g., for FDA, EMA) by providing impurity characterization data required for drug approval.
• Quality Control (QC) Testing: Serves as a system suitability and calibration standard in routine QC release testing of Eptifibatide batches.
• Stability Studies: Used to assess the degradation kinetics of Eptifibatide under various stress conditions (e.g., heat, humidity, pH).

Basic Information

Product Name	Eptifibatide impurity 3/Deamidated Eptifibatide Impurity/(3R,11S,17S,20S,25aS)-20-((1H-indol-3-yl)Methyl)-17-(carboxymethyl)-11-(4-guanidinobutyl)-1,9,12,15,18,21-hexaoxodocosahydro-1H-pyrrolo[2,1-g][1,2,5,8,11,14,17,20]dithiahexaazacyclotricosine-3-carbo
CAS No.	618118-95-9
Molecular Formula	C35H49N11O9S2
Molecular Weight	831.96 g/mol
Synonyms	Deamidated Eptifibatide; Eptifibatide Related Compound C; Integrilin Impurity 3; (3R,11S,17S,20S,25aS)-20-((1H-Indol-3-yl)methyl)-17-(carboxymethyl)-11-(4-guanidinobutyl)-1,9,12,15,18,21-hexaoxodocosahydro-1H-pyrrolo[2,1-g][1,2,5,8,11,14,17,20]dithiahexaazacyclotricosine-3-carboxylic Acid; Nα-(3-Mercaptopropionyl)-N6-(carbamimidoyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6),(2→7)-disulfide (Deamidated Form); Cyclo(S,S)-[Mpr-Har-Gly-Asp-Trp-Pro-Cys]-OH (Deamidated); Eptifibatide Deamidation Product.
EINECS	Contact for details

Quality Control

Our Eptifibatide impurity 3 is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure structural identity and high purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for purity, impurities, and chromatographic profile. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards used in GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation and moisture uptake. For short-term storage (up to one month), store at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with molecular structure
Purity (HPLC, Area%)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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