Description

Cinacalcet Impurity 9 is a designated pharmaceutical reference standard used for quality control and analytical research. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Cinacalcet HCl during development and manufacturing. It serves as a key marker for identifying and quantifying process-related impurities. This high-purity standard is essential for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory compliance teams.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for Cinacalcet HCl method development and validation.
• Quality Control & Assurance: Critical for monitoring and controlling impurity profiles in Cinacalcet API batches to meet pharmacopeial (USP, EP) and ICH guidelines.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic studies for impurity identification, characterization, and quantification.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity data.
• Stability Studies: Employed as a marker to track impurity formation in Cinacalcet drug products under various storage conditions.
• Process Chemistry Optimization: Helps chemists identify and minimize the formation of this specific impurity during API synthesis and scale-up.

Basic Information

Product Name	Cinacalcet Impurity 9
CAS No.	802918-36-1
Molecular Formula	C22H22F3N
Molecular Weight	357.42 g/mol
Synonyms	N-[1-(R)-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; Cinacalcet Process Impurity; Cinacalcet Degradant; Sensipar Impurity; Mimpara Impurity
EINECS	Contact for details

Quality Control

Every batch of Cinacalcet Impurity 9 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, aligning with ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurity profile.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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