Description

Cinacalcet is a potent 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 development of treatments for secondary hyperparathyroidism and hypercalcemia. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the synthesis of active pharmaceutical ingredients (APIs) and the development of novel therapeutic agents targeting mineral metabolism disorders.

Application

• Pharmaceutical API Synthesis: Serves as the key active pharmaceutical ingredient (API) in medications for secondary hyperparathyroidism.
• Research & Development: Used as a reference standard and biochemical tool in pharmacological studies of calcium-sensing receptor (CaSR) signaling pathways.
• Formulation Development: Employed in pre-formulation and formulation studies for developing stable oral dosage forms, such as tablets.
• Metabolic Disorder Research: Investigated in preclinical research for potential applications in treating disorders related to calcium and parathyroid hormone (PTH) regulation.
• Generic Drug Manufacturing: Essential for companies producing generic versions of calcimimetic drugs following patent expiration.
• Quality Control Laboratories: Used as an analytical reference standard for HPLC and other chromatographic methods to ensure drug purity and potency.

Basic Information

Product Name	Cinacalcet
CAS No.	1034094-54-6
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	Cinacalcet Hydrochloride (API form); AMG 073; Sensipar (Brand Name); Mimpara (Brand Name); N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine; (R)-N-(1-Naphthalen-1-ylethyl)-3-[3-(trifluoromethyl)phenyl]propan-1-amine
EINECS	Contact for details

Quality Control

Our Cinacalcet is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical development. Each batch undergoes comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via advanced techniques like HPLC and chiral chromatography to ensure enantiomeric purity. A Certificate of Analysis (COA) detailing all test results is provided with every shipment, supporting compliance with cGMP and ICH guidelines for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Enantiomeric Purity (Chiral HPLC)	≥99.0% (R-isomer)
Related Substances (HPLC)	Total impurities ≤1.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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