Description

Ecallantide CAS NO 460738-38-9 is a potent and selective recombinant plasma kallikrein inhibitor, a critical therapeutic agent derived from biotechnology. Its primary value lies in its targeted mechanism of action for treating acute attacks of hereditary angioedema (HAE) by inhibiting the kallikrein-kinin pathway. This makes it an essential pharmaceutical active ingredient for manufacturers developing life-saving injectable treatments. It is primarily utilized by pharmaceutical companies and research institutions focused on hematology, immunology, and rare disease therapeutics.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key therapeutic component in injectable formulations for the treatment of hereditary angioedema (HAE).
• Clinical Research & Development: Utilized in preclinical and clinical studies for investigating new therapeutic applications related to kallikrein inhibition.
• Biopharmaceutical Manufacturing: Serves as a critical raw material in the GMP-compliant production of finished drug products (e.g., Kalbitor®).
• Reference Standard: Used in analytical laboratories as a high-purity standard for quality control testing, method development, and validation.
• Mechanistic Studies: Employed in biochemical research to study the role of plasma kallikrein in inflammatory and bradykinin-mediated pathways.

Basic Information

Product Name	Ecallantide
CAS No.	460738-38-9
Molecular Formula	C174H271N55O53
Molecular Weight	4054.3 g/mol
Synonyms	DX-88; Kalbitor; Recombinant Plasma Kallikrein Inhibitor; rHAI; Ecallantide recombinant; Ecallantidum; UNII-82X1X82P8T; (L-3-carboxy-2-hydroxypropyl)-L-methionyl-L-α-glutamylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinyl-L-arginyl-L-α-aspartyl-L-alanylglycyl-L-cysteinyl-L-methionyl-L-α-aspartyl-L-phenylalanyl-L-prolyl-L-lysyl-L-prolyl-L-prolyl-L-prolylglycyl-L-prolyl-L-prolyl-L-prolyl-L-lysyl-L-arginyl-L-arginyl-L-prolyl-L-histidyl-L-prolyl-L-glutaminyl-L-seryl-lysyl-L-valyl-L-α-aspartylglycyl-L-tryptophyl-L-cysteinyl-L-phenylalanyl-L-valyl-L-prolyl-L-cysteinyl-L-threonyl-L-lysyl-L-serine cyclic (1-60),(7-35)-bis(disulfide)
EINECS	Contact for details

Quality Control

Our Ecallantide is manufactured under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including HPLC for purity and potency, peptide mapping, and tests for related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided, confirming compliance with in-house specifications aligned with ICH guidelines. We support regulatory filings with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated. Allow the vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to theoretical mass
Purity (HPLC)	≥ 98.0%
Assay (Potency)	95.0% - 105.0% of labeled
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 5.0%
Acetate Content (HPLC)	Report result
Bacterial Endotoxins	< 10 EU/mg
Sterility (Membrane Filtration)	Sterile

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