Description

Cinacalcet Impurity 49 is a designated impurity reference standard used in the pharmaceutical development and quality control of Cinacalcet HCl, a calcimimetic agent. This high-purity compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Cinacalcet HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor impurity profiles.
• Quality Control and Batch Release: Used in routine QC testing to ensure drug substance and product batches meet stringent purity specifications per ICH guidelines.
• Stability Studies: Employed to identify and track degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Research and Development: Aids in process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Cinacalcet Impurity 49
CAS No.	1622173-75-4
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine; Cinacalcet Related Compound 49; Cinacalcet EP Impurity I; Cinacalcet USP Impurity; (R)-N-(1-Naphthalen-1-ylethyl)-3-[3-(trifluoromethyl)phenyl]propan-1-amine; Cinacalcet Degradation Product; Cinacalcet Process Impurity
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 49 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 characterized and qualified using advanced techniques including HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This product is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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