Description

Cinacalcet Impurity 4 is a designated impurity of the active pharmaceutical ingredient Cinacalcet HCl, a calcimimetic agent used to treat secondary hyperparathyroidism. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for laboratories and manufacturers in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Cinacalcet HCl API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, LC-MS) to meet ICH Q3A/B guidelines.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Cinacalcet.
• Essential for quality control (QC) and quality assurance (QA) laboratories to establish specification limits and ensure batch-to-batch consistency.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profile data.
• Valuable for research and development of generic formulations and process optimization.

Basic Information

Product Name	Cinacalcet Impurity 4
CAS No.	955373-56-5
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; Cinacalcet EP Impurity; Cinacalcet USP Impurity; Sensipar Impurity; Mimpara Impurity
EINECS	Contact for details

Quality Control

Our Cinacalcet Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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