Description

Cinacalcet Impurity C is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Cinacalcet HCl, a calcimimetic agent. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and regulatory compliance. The use of this well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements for drug substance and finished product quality.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Cinacalcet-related impurities.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish and validate chromatographic methods for impurity profiling of Cinacalcet API.
• Quality Control & Batch Release Testing: Employed in routine QC labs to monitor impurity levels against established specifications in drug substance and drug product manufacturing.
• Stability Studies: Used to track the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) to determine drug shelf-life.
• Regulatory Compliance & Submission: Critical for preparing documentation required by regulatory bodies (FDA, EMA, etc.) to demonstrate control of the impurity profile.
• Research & Development: Utilized in R&D to understand the degradation pathways and chemistry of Cinacalcet during synthesis and formulation.

Basic Information

Product Name	Cinacalcet Impurity C
CAS No.	1207533-91-2
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	(R)-N-((1-Naphthyl)ethyl)-3-(trifluoromethyl)benzylamine; (R)-1-(1-Naphthyl)-N-((3-(trifluoromethyl)phenyl)methyl)ethanamine; Cinacalcet Related Compound C; Cinacalcet EP Impurity C; Cinacalcet USP Impurity C; Sensipar Impurity C; Mimpara Impurity C
EINECS	Contact for details

Quality Control

Every batch of Cinacalcet Impurity C is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the needs of cGMP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider conditions that minimize exposure to temperature fluctuations and humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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