Description

Cinacalcet Impurity 5 is a designated impurity of the active pharmaceutical ingredient Cinacalcet HCl, a calcimimetic agent used to treat secondary hyperparathyroidism. This impurity is a critical reference standard for pharmaceutical research and development, ensuring the safety, efficacy, and regulatory compliance of Cinacalcet-based drug products. It is essential for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and regulatory testing laboratories.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cinacalcet Impurity 5 in drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Critical for routine quality control testing to ensure drug substance and product purity meets ICH and pharmacopeial guidelines (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate comprehensive impurity control.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve synthetic processes to minimize impurity formation.

Basic Information

Product Name	Cinacalcet Impurity 5
CAS No.	1431699-53-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cinacalcet Related Compound 5; Cinacalcet Impurity C; Cinacalcet EP Impurity C; (R)-N-((1-Naphthyl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Impurity; AMG 073 Impurity 5; Sensipar Impurity 5; Mimpara Impurity 5
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 5 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and controlled using validated methods, including HPLC, GC, MS, and NMR, to confirm identity, purity, and strength. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

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