Description

Cinacalcet Impurity 37 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 ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Cinacalcet HCl.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Cinacalcet HCl API.
• Analytical Method Development: Used to establish and optimize HPLC/UPLC methods for the accurate identification and quantification of related substances.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed as a marker to monitor impurity profiles in stability testing of Cinacalcet HCl drug substance and drug product under various ICH conditions.
• Pharmacopoeial Testing: Facilitates compliance with pharmacopoeial monographs (USP, EP, etc.) that specify limits for related compounds.
• Process Chemistry R&D: Aids in the identification and control of process-related impurities during the synthesis and purification of Cinacalcet HCl.

Basic Information

Product Name	Cinacalcet Impurity 37
CAS No.	64189-17-9
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine; (R)-N-[1-(Naphthalen-1-yl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine; Cinacalcet Related Compound 37; Cinacalcet EP Impurity G; Cinacalcet USP Impurity; AMG 073 Impurity 37
EINECS	Contact for details

Quality Control

Every batch of Cinacalcet Impurity 37 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A/B guidelines and pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.