Description

Cinacalcet Impurity 7 is a designated impurity of the active pharmaceutical ingredient Cinacalcet Hydrochloride, a calcimimetic agent. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Cinacalcet drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cinacalcet Impurity 7 in drug substances and finished dosage forms.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control impurity levels to meet ICH Q3A/B guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Process Chemistry Research: Aids in optimizing synthetic routes and purification processes to minimize the formation of this impurity during Cinacalcet manufacturing.

Basic Information

Item	Detail
Product Name	Cinacalcet Impurity 7
CAS No.	802918-47-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[1-(R)-(-)-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propylamine; (R)-N-[1-(Naphthalen-1-yl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine; Cinacalcet Related Compound; Cinacalcet EP Impurity; Cinacalcet USP Impurity; AMG 073 Impurity
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 7 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation by spectroscopic methods, and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.