Description

Etelcalcetide CAS NO 1262780-97-1 is a synthetic peptide calcimimetic agent designed to modulate calcium-sensing receptors. This compound is of significant commercial and therapeutic importance for the management of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. It is primarily required by pharmaceutical manufacturers engaged in the production of advanced injectable therapeutics. The product is supplied as a high-purity active pharmaceutical ingredient (API) for formulation development and commercial drug product manufacturing.

Application

• Primary Active Pharmaceutical Ingredient (API) for the injectable drug Parsabiv® (etelcalcetide).
• Formulation research and development of calcimimetic therapies.
• Manufacturing of lyophilized (freeze-dried) powder for injection.
• Clinical trial material supply for novel therapeutic studies.
• Reference standard for analytical method development and validation in quality control laboratories.
• Biochemical research focusing on calcium homeostasis and parathyroid hormone (PTH) regulation.

Basic Information

Product Name	Etelcalcetide
CAS No.	1262780-97-1
Molecular Formula	C73H122N22O22S2
Molecular Weight	1724.0 g/mol
Synonyms	AMG 416; Velcalcetide; Etelcalcetide Hydrochloride; (L-Cysteinamide, N-acetyl-L-methionyl-L-α-glutamyl-L-α-glutamyl-L-histidyl-L-leucyl-L-seryl-L-lysyl-N6-[N-(4-[[(2R)-2-amino-2-carboxyethyl]thio]-1-oxobutyl)-L-lysyl]-L-leucyl-L-α-glutamyl-L-α-glutamyl-L-seryl-L-leucyl-L-α-glutamyl-L-arginyl-L-phenylalanyl-L-phenylalanyl-, cyclic (7→12),(16→20)-bis(disulfide)); Parsabiv (Brand Name)
EINECS	Contact for details

Quality Control

Our Etelcalcetide is manufactured under strict quality systems compliant with cGMP guidelines for active pharmaceutical ingredients. Each batch undergoes comprehensive analytical testing including HPLC for purity and related substances, peptide mapping, and residual solvent analysis to ensure it meets stringent pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing identity, purity, potency, and microbiological data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Bacterial Endotoxins	< 1.0 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12/2.6.13

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