Description

Etelcalcetide HCl is a second-generation calcimimetic peptide therapeutic agent used to manage secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. It functions as a positive allosteric modulator of the calcium-sensing receptor (CaSR), enabling precise control of parathyroid hormone (PTH) secretion. This compound is critical for pharmaceutical manufacturers developing parenteral formulations, contract development and manufacturing organizations (CDMOs), and regulatory-compliant API suppliers serving global biopharma markets. Etelcalcetide Hcl CAS NO 1334237-71-6 is supplied as a high-purity active pharmaceutical ingredient meeting stringent quality benchmarks for clinical and commercial-scale production.

Application

• Active Pharmaceutical Ingredient (API) for intravenous SHPT therapeutics (e.g., Parsabiv®-equivalent formulations)
• Reference standard in pharmacopeial testing (USP, EP, JP) for assay, impurity profiling, and stability studies
• Raw material for GMP-compliant lyophilized drug product development and process validation
• Research-grade compound for CaSR mechanism-of-action studies and PK/PD modeling in preclinical nephrology models
• Calibration standard in LC-MS/MS and HPLC-UV bioanalytical method development for plasma and dialysate PTH suppression monitoring
• Stability-indicating reference material for forced degradation studies (hydrolysis, oxidation, photolysis)

Basic Information

Product Name	Etelcalcetide HCl
CAS No.	1334237-71-6
Molecular Formula	C₇₆H₁₂₀ClN₂₀O₂₄S₄
Molecular Weight	1835.56 g/mol
Synonyms	Etelcalcetide hydrochloride; AMG 416 hydrochloride; (2S,4R)-1-[(2R)-2-({[(2R)-2-({[(2R)-2-({[(2R)-2-({[(2R)-2-({[(2R)-2-amino-3-methylbutanoyl]amino}acetyl)amino]acetyl)amino}acetyl)amino]acetyl)amino}acetyl)amino]acetyl)amino]-4-methylpentanoic acid hydrochloride; AMG-416•HCl; Etelcalcetide chloride; N-(L-Valyl)-N-((2S,4R)-4-methyl-2-((2R)-2-((2R)-2-((2R)-2-((2R)-2-((2R)-2-((2R)-2-aminopropanoylamino)propanoylamino)propanoylamino)propanoylamino)propanoylamino)propanoylamino)pentanoyl)glycine hydrochloride; UNII-983KX8QZ5B
EINECS	Not listed (not required for pharmaceutical substances under EINECS scope)

Quality Control

Our Etelcalcetide HCl is manufactured under strict cGMP conditions and undergoes comprehensive quality testing to ensure compliance with USP-NF, EP 10.0, and ICH Q5–Q7 guidelines. Each batch is verified for identity, assay, chiral purity, residual solvents, heavy metals, endotoxins, and related substances using validated HPLC, LC-MS, chiral CE, and KF titration methods. Certificates of Analysis (COA), Certificates of Compliance (CoC), and full regulatory support dossiers (DMF-ready) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (nitrogen or argon) to prevent oxidation and moisture uptake. Due to its hygroscopic nature, maintain relative humidity below 30% during storage and handling. Avoid repeated exposure to ambient air and temperature fluctuations.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0–102.0%
Related Substances (HPLC)	Any single impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C limits (Acetonitrile ≤ 410 ppm; Water ≤ 5.0%)
Water (KF)	≤ 5.0%
Heavy Metals	≤ 10 ppm
Bacterial Endotoxins	≤ 5.0 EU/mg
Bioburden	<10 CFU/g

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