Description

Cinacalcet Impurity 2 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Cinacalcet HCl. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Cinacalcet-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Cinacalcet API and finished dosage forms.
• Analytical Research & Development: Used in HPLC, UPLC, and LC-MS studies to establish impurity profiles, degradation pathways, and stability-indicating methods.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies (ICH Q3A/B).
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (USP, EP, BP) that specify limits for related substances.
• Stability Studies: Employed as a marker to monitor impurity formation during forced degradation and long-term stability studies of the drug substance.
• Contract Research & Manufacturing (CRO/CMO): A vital material for third-party laboratories providing analytical and quality control services to the pharmaceutical industry.

Basic Information

Product Name	Cinacalcet Impurity 2
CAS No.	1638501-43-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cinacalcet Related Compound 2; Cinacalcet Impurity B; Cinacalcet EP Impurity B; Cinacalcet USP Impurity; (R)-N-((1-Naphthyl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine Impurity; Sensipar Impurity 2; Mimpara Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Cinacalcet Impurity 2 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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