Description

Cinacalcet Hydrochloride Impuritiii is a designated impurity standard used in the pharmaceutical development and quality control of Cinacalcet Hydrochloride, a calcimimetic agent. This reference material is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by enabling accurate identification and quantification of process-related impurities. It is an essential tool for analytical laboratories, quality assurance departments, and research scientists within the pharmaceutical industry who are involved in method development, stability studies, and regulatory compliance for Cinacalcet Hydrochloride formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method validation and routine quality control testing of Cinacalcet Hydrochloride API.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and quantify this specific impurity.
• Stability Indicating Studies: Used to monitor the formation of this impurity during forced degradation and long-term stability studies of Cinacalcet Hydrochloride drug substance and products.
• Regulatory Submission Support: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits in accordance with ICH Q3A and Q3B guidelines.
• Process Chemistry Research: Aids in understanding the synthesis pathway of Cinacalcet Hydrochloride, helping to identify and mitigate the source of this impurity during manufacturing.
• Quality Assurance & Batch Release: Serves as a system suitability and identification standard in the quality control release testing of commercial API batches.

Basic Information

Product Name	Cinacalcet Hydrochloride Impuritiii
CAS No.	2436762-80-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cinacalcet HCl Impurity iii; Cinacalcet Related Compound iii; Cinacalcet Hydrochloride Related Substance iii; Cinacalcet Process Impurity; NPS R-568 Impurity; Sensipar Impurity; Mimpara Impurity; Calcimimetic Impurity Standard
EINECS	Contact for details

Quality Control

Our impurity standards are produced and characterized under strict quality systems to ensure high purity, accurate identification, and reliable quantification. Each batch is thoroughly analyzed using advanced techniques including HPLC, GC-MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the requirements for pharmaceutical reference materials as guided by ICH and pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent absorption of moisture, which could affect stability and analytical performance.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C limits

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