Description

Cinacalcet Impurity 10 is a designated impurity of the active pharmaceutical ingredient Cinacalcet HCl, used in the treatment of secondary hyperparathyroidism. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Cinacalcet-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic analyses.
• Method Development and Validation: Critical for developing and validating stability-indicating methods for Cinacalcet API and finished dosage forms.
• Quality Control & Assurance: Used in routine QC testing to monitor and control impurity levels during API synthesis and drug manufacturing.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization and qualification data.
• Stability Studies: Employed to identify and quantify degradation products in forced degradation and long-term stability studies of Cinacalcet.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Cinacalcet to minimize impurity formation.

Basic Information

Product Name	Cinacalcet Impurity 10
CAS No.	1809324-40-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cinacalcet Related Compound 10; Cinacalcet EP Impurity J; Cinacalcet USP Impurity; N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine Impurity; Sensipar Impurity 10; Mimpara Impurity 10; (R)-N-(1-Naphthalen-1-yl-ethyl)-3-(3-trifluoromethyl-phenyl)-propylamine Impurity 10
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic characterization (NMR, MS), to ensure identity, strength, and composition. Certificates of Analysis (COA) with detailed chromatographic data are provided to support its use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%

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