Description

Cinacalcet Impurity 11 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Cinacalcet HCl. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and regulatory compliance testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cinacalcet Impurity 11 in Cinacalcet HCl API and related drug formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure API and drug products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress and long-term storage conditions.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Cinacalcet, helping to improve formulation stability.

Basic Information

Product Name	Cinacalcet Impurity 11
CAS No.	78573-44-1
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	(R)-N-((1-Naphthyl)ethyl)-3-(trifluoromethyl)benzylamine; (R)-1-(1-Naphthyl)-N-[3-(trifluoromethyl)benzyl]ethanamine; (R)-1-(Naphthalen-1-yl)-N-[3-(trifluoromethyl)benzyl]ethanamine; Cinacalcet Related Compound; Cinacalcet EP Impurity; Cinacalcet USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Cinacalcet Impurity 11 is produced and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material 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 structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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