Description

Cinacalcet Impurity B is a designated pharmaceutical reference standard used for quality control and analytical research. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Cinacalcet HCl during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cinacalcet Impurity B in Cinacalcet HCl API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component for developing, optimizing, and validating chromatographic methods to monitor impurities.
• Quality Control & Batch Release Testing: Essential for routine quality control testing of Cinacalcet API to ensure compliance with pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies & Forced Degradation Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Documentation & Submission: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of the Cinacalcet molecule.

Basic Information

Product Name	Cinacalcet Impurity B
CAS No.	66469-40-7
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine; (R)-N-[1-(Naphthalen-1-yl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine; Cinacalcet Related Compound B; Cinacalcet EP Impurity B; Cinacalcet USP Impurity B; (R)-1-(1-Naphthyl)-N-(3-(3-(trifluoromethyl)phenyl)propyl)ethanamine
EINECS	Contact for details

Quality Control

Every batch of Cinacalcet Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B guidelines, and major pharmacopeial standards.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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