Description

Cinacalcet Impurity 3 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Cinacalcet Hydrochloride. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and routine batch release testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Cinacalcet Impurity 3 in Cinacalcet HCl API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that impurity levels in commercial API batches comply with strict pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the API's impurity profile.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during API synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Cinacalcet Impurity 3
CAS No.	2514625-50-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cinacalcet Related Compound 3; Cinacalcet Hydrochloride Impurity 3; (R)-N-((1-Naphthyl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Impurity; (R)-1-(Naphthalen-1-yl)-N-(3-(3-(trifluoromethyl)phenyl)propyl)ethan-1-amine Impurity; Sensipar Impurity 3; Mimpara Impurity 3
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 3 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, GC, NMR, and MS. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines, and our quality commitment ensures this reference material meets the exacting standards required for pharmaceutical development and regulatory applications.

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 must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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