Description

Cinacalcet Hydrochloride CAS NO 364782-34-3 is a potent and selective calcimimetic agent that acts as an allosteric modulator of the calcium-sensing receptor (CaSR). This compound is of critical importance in the pharmaceutical industry for the regulation of parathyroid hormone (PTH) secretion. It is primarily required by manufacturers of active pharmaceutical ingredients (APIs) and finished dosage forms for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and for hypercalcemia in patients with parathyroid carcinoma.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the formulation of calcimimetic medications.
• Secondary Hyperparathyroidism Treatment: Key component in drugs for managing mineral and bone disorder in chronic kidney disease patients on dialysis.
• Parathyroid Carcinoma Therapy: Used in medications to lower serum calcium levels in patients with this condition.
• Pharmaceutical Research & Development: Serves as a reference standard and building block in metabolic bone disease research.
• Generic Drug Manufacturing: Essential for producing bioequivalent versions of branded calcimimetic drugs.
• Clinical Trial Materials: Supplied for use in studies exploring new indications or formulations.

Basic Information

Product Name	Cinacalcet Hydrochloride
CAS No.	364782-34-3
Molecular Formula	C22H22F3N•HCl
Molecular Weight	393.87 g/mol (as hydrochloride salt)
Synonyms	N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine hydrochloride; AMG 073 hydrochloride; Sensipar (Brand Name); Mimpara (Brand Name); Calcimimetic Cinacalcet HCl; (R)-N-[1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine hydrochloride
EINECS	Contact for details

Quality Control

Our Cinacalcet Hydrochloride is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with agreed-upon standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

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% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details

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