Description

Cinacalcet Impurity D 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 for method development, validation, and quality assurance processes in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Cinacalcet Impurity D in Cinacalcet API and finished drug products.
• Analytical Method Development: Used in research and development (R&D) laboratories to develop and validate sensitive HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical QC labs to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed as a benchmark to track the formation of degradation products in Cinacalcet formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global regulatory requirements.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Cinacalcet to minimize the formation of this specific impurity.

Basic Information

Product Name	Cinacalcet Impurity D
CAS No.	1271930-15-4
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	(R)-N-((1-Naphthyl)ethyl)-3-(trifluoromethyl)benzylamine; (R)-1-(Naphthalen-1-yl)-N-(3-(trifluoromethyl)benzyl)ethan-1-amine; Cinacalcet Related Compound D; Cinacalcet EP Impurity D; Cinacalcet USP Impurity D; Cinacalcet RRT 0.9 Impurity; (R)-1-(1-Naphthyl)-N-[3-(trifluoromethyl)benzyl]ethylamine
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), 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 and confirming compliance with relevant specifications.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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