Eptifibatide Powder Cas No.188627-80-7

Eptifibatide Powder Cas No.188627-80-7

Product Name: Eptifibatide Powder
Specification: ≥99%
CAS No.: 188627-80-7
Molecular Formula: C₃₅H₄₉N₁₁O₉S₂
Molecular Weight: 831.96 g/mol
Test Method: HPLC
Active Ingredient: Eptifibatide (a cyclic heptapeptide)
Characteristics: White or off-white solid powder
Packaging: 1-100g; 1kg/foil bag; 25kg/drum
Storage Condition: Store in a cool, dry place sealed container protected from light and moisture
Shelf Life: 24 months

Declaration of Use: This product is intended for industrial use or scientific research only.
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Eptifibatide API Powder CAS 188627-80-2

Why Is Eptifibatide The Gold Standard GP IIb/IIIa Receptor Antagonist?

CAS Number: 188627-80-2
Molecular Formula: C35H49N11O9S2
Molecular Weight: 831.96 g/mol
Assay Standard: ≥ 99.0% (HPLC)

1. Product Characterization & Formulation Value

Xi'an Tihealth manufactures high-purity Eptifibatide API, a synthetic, disulfide-linked cyclic heptapeptide designed specifically for intravenous antithrombotic formulations. Functioning as a highly competitive and reversible antagonist of the platelet glycoprotein (GP) IIb/IIIa receptor, it represents a critical active pharmaceutical ingredient for mitigating acute ischemic events during percutaneous coronary interventions (PCI).

Peptide synthesis at a commercial scale requires uncompromising control over related impurities. Our solid-phase peptide synthesis (SPPS) and subsequent advanced reverse-phase HPLC purification protocols ensure that our Eptifibatide API consistently exceeds 99.0% purity. We rigorously control trifluoroacetic acid (TFA) residues, moisture content, and bacterial endotoxins, delivering a sterile-grade precursor ideal for the compounding of generic acute coronary syndrome (ACS) injectables.

2. Technical Data Sheet (TDS) & Specifications

Quality Parameter Pharmaceutical Specification Standard (EP / USP)
Sequence Mpa-Har-Gly-Asp-Trp-Pro-Cys-NH2 (Disulfide bridge: 1-7)
Assay / Purity (HPLC) ≥ 99.0%
Peptide-Related Impurities Individual Impurity ≤ 0.50%; Total Impurities ≤ 1.0%
Physical Appearance White to off-white lyophilized powder
Water Content (Karl Fischer) ≤ 8.0%
Acetate Content (HPLC) 5.0% - 15.0% (Supplied as Eptifibatide Acetate salt)
TFA (Trifluoroacetic Acid) Residue ≤ 0.25% (Strictly controlled via ion exchange)
Bacterial Endotoxins ≤ 5.0 EU/mg (Suitable for parenteral formulation)

3. Pharmacological & Receptor Binding Mechanisms

High-Affinity KGD Motif Recognition

Unlike non-specific inhibitors, Eptifibatide is modeled after barbourin, a protein found in rattlesnake venom. It utilizes a highly specific Lys-Gly-Asp (KGD) amino acid sequence motif to selectively bind the GP IIb/IIIa receptor on activated platelets, preventing fibrinogen cross-linking and subsequent thrombus aggregation.

Rapid Reversibility Profile

In acute cardiac care, managing bleeding risks is paramount. Eptifibatide exhibits a highly favorable pharmacokinetic profile: it is a reversible antagonist. Following the cessation of intravenous infusion, platelet function and normal hemostasis recover rapidly (typically within 4 hours), offering precise clinical control.

4. Core Pharmaceutical Applications

  • Acute Coronary Syndrome (ACS) Injectables: Serves as the primary active pharmaceutical ingredient for intravenous solutions used in the medical management of unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI).
  • Percutaneous Coronary Intervention (PCI): Formulated into sterile IV drips to prevent ischemic complications and stent thrombosis during balloon angioplasty and stent placement procedures.
  • Cardiovascular Formulation R&D: Utilized in laboratory environments for generic bioequivalence studies and the development of novel peptide-based antithrombotic delivery systems.

5. Frequently Asked Sourcing Questions

What are the cold chain storage and shipping requirements for Eptifibatide API?
As a lyophilized cyclic peptide, Eptifibatide requires strict temperature control to prevent degradation. We package the API in fluorinated pharmaceutical-grade bottles or double-layer sterile PE bags, shipped globally via verified cold-chain logistics (maintained at 2°C to 8°C). Long-term storage in manufacturing facilities should be kept refrigerated or at -20°C, protected from light and moisture.
How does Xi'an Tihealth control TFA (Trifluoroacetic Acid) residues?
TFA is commonly used in peptide cleavage but poses toxicity risks in final injectables. Through advanced salt-exchange chromatography, we successfully convert the crude peptide into Eptifibatide Acetate, strictly limiting residual TFA to ≤ 0.25%, ensuring complete compliance for parenteral drug formulation.
Is full peptide impurity profiling provided with the COA?
Yes. Each batch comes with a comprehensive Certificate of Analysis (COA) and HPLC chromatograms detailing single maximum unspecified impurities and total peptide-related impurities. Mass spectrometry (MS) reports confirming the precise molecular weight (831.96) and disulfide bond integrity are also included in the technical dossier for generic filing support.
Regulatory and Safety Disclaimer: This product is supplied exclusively as a bulk Active Pharmaceutical Ingredient (API) for authorized commercial compounding, industrial pharmaceutical manufacturing, and laboratory R&D use. It is not a finished intravenous drug product and must not be administered directly to patients. Formulators are responsible for all downstream sterile processing, pyrogen testing, and regional regulatory compliance.

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