Description

Ent-Cinacalcet Hydrochloride is the enantiomer of the active pharmaceutical ingredient Cinacalcet, serving as a critical reference standard and intermediate in pharmaceutical research and development. This compound is essential for analytical method development, impurity profiling, and stereochemical studies related to calcimimetic drugs. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the synthesis and quality control of therapeutics for secondary hyperparathyroidism and related disorders.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification, assay, and impurity testing of Cinacalcet HCl in active pharmaceutical ingredient (API) and finished dosage forms.
• Process Research & Development (R&D): Acts as a key chiral intermediate or starting material in the stereoselective synthesis and route scouting for calcimimetic agents.
• Analytical Method Development: Employed in validating chromatographic methods (HPLC, UPLC, Chiral HPLC) to separate and quantify enantiomeric impurities.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on stereoisomers for impurity identification and qualification.
• Academic & Clinical Research: Facilitates pharmacological studies to understand the structure-activity relationship (SAR) and metabolic pathways of cinacalcet enantiomers.
• Quality Control (QC) Laboratories: Serves as a system suitability test compound and for routine batch release testing in API manufacturing facilities.

Basic Information

Product Name	Ent-Cinacalcet Hydrochloride
CAS No.	694495-47-1
Molecular Formula	C22H23ClF3N • HCl
Molecular Weight	394.79 g/mol (Free base: 393.87)
Synonyms	(R)-N-[1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine Hydrochloride; (R)-Cinacalcet Hydrochloride; Cinacalcet Impurity F (Enantiomer); (R)-Cinacalcet; AMG 073 Enantiomer; Sensipar Enantiomer; Mimpara Enantiomer; UNII-1K860WSG25
EINECS	Contact for details

Quality Control

Our Ent-Cinacalcet Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity determination, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity (typically ≥98.0% by HPLC), enantiomeric excess, and related substances. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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