Description

Cinacalcet Impurity 38 Hcl is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Cinacalcet HCl. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Cinacalcet HCl active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine batch testing to ensure API and drug product purity meets pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Cinacalcet formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy for the drug substance.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Cinacalcet Impurity 38 Hcl
CAS No.	938177-81-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cinacalcet Related Compound 38; Cinacalcet Impurity 38 Hydrochloride; Cinacalcet EP Impurity H; Cinacalcet USP Impurity; (R)-N-((1-Naphthyl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Hydrochloride Impurity; Sensipar Impurity 38 HCl; Mimpara Impurity 38 HCl
EINECS	Contact for details

Quality Control

Every batch of Cinacalcet Impurity 38 Hcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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