Description

Cinacalcet Impurity 13 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, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical laboratories and pharmaceutical manufacturers engaged in method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods.
• Method Development and Validation: Critical for developing and validating analytical procedures to monitor Cinacalcet API purity.
• Quality Control & Batch Release: Used in routine QC testing to ensure Cinacalcet drug substance and product meet ICH impurity guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity profiles.
• Research and Development: Aids in synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Cinacalcet Impurity 13
CAS No.	2074615-22-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cinacalcet Related Compound 13; Cinacalcet Impurity; (R)-N-((1-Naphthyl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Impurity; Sensipar Impurity 13; Mimpara Impurity 13; (R)-1-(Naphthalen-1-yl)-N-(3-(3-(trifluoromethyl)phenyl)propyl)ethan-1-amine Impurity
EINECS	Contact for details

Quality Control

Every batch of Cinacalcet Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards for 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) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
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.