Description

Cinacalcet Impurity 45 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Cinacalcet HCl by serving as a key marker for impurity profiling and control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Cinacalcet-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Cinacalcet Impurity 45 in drug substances and products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly HPLC and LC-MS, for impurity detection.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control the level of this specific impurity during Cinacalcet API manufacturing.
• Stability Studies: Employed to track the formation of this impurity in drug products under various stress and long-term storage conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and justify specifications.
• Research and Development: Supports R&D investigations into the degradation pathways and chemical behavior of the Cinacalcet molecule.

Basic Information

Product Name	Cinacalcet Impurity 45
CAS No.	136908-26-4
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)benzyl)ethanamine; Cinacalcet Related Compound; Cinacalcet EP Impurity; Sensipar Impurity; Mimpara Impurity; (R)-N-[1-(Naphthalen-1-yl)ethyl]-1-[3-(trifluoromethyl)phenyl]methanamine
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 45 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B and USP/EP guidelines. COAs are available upon request.

Storage

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

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 individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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