Description

Cinacalcet Impurity 53 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Cinacalcet HCl. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Cinacalcet HCl API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of the drug substance.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to support process optimization and impurity clearance studies.

Basic Information

Product Name	Cinacalcet Impurity 53
CAS No.	329-02-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine; Cinacalcet Related Compound; Cinacalcet EP Impurity; Cinacalcet USP Impurity; Sensipar Impurity; Mimpara Impurity; (R)-N-[1-(Naphthalen-1-yl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 53 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for use as a pharmaceutical reference material. Certificates of Analysis (COA) with detailed chromatographic data and traceable lot numbers are provided to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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