Description

Cinacalcet Impurity 74 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 enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and regulatory bodies engaged in method development, validation, and stability studies. The availability of a well-characterized impurity standard is fundamental to meeting stringent global regulatory requirements for drug substance and drug product purity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cinacalcet Impurity 74 in Cinacalcet HCl API and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating stability-indicating HPLC/UPLC methods for Cinacalcet and its related substances.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products in Cinacalcet formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to establish impurity acceptance criteria and control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis and purification processes.

Basic Information

Product Name	Cinacalcet Impurity 74
CAS No.	802918-49-6
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	(R)-N-((1-Naphthyl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine; (R)-1-(Naphthalen-1-yl)-N-(3-(3-(trifluoromethyl)phenyl)propyl)ethan-1-amine; Cinacalcet Related Compound 74; Cinacalcet EP Impurity H; Cinacalcet USP Impurity; Cinacalcet Process Impurity; Sensipar Impurity 74; Mimpara Impurity 74
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 74 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, GC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity, assay, and residual solvent analysis, ensuring compliance with ICH guidelines and relevant pharmacopeial standards. The material is suitable for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 2.0%
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.