Description

Rac Cinacalcet-D3 Hydrochloride CAS NO 1185097-33-9 is a deuterated isotopologue of the calcimimetic agent cinacalcet, specifically designed for use as an internal standard in analytical chemistry. This high-purity reference material is critical for ensuring the accuracy and reliability of quantitative analyses in pharmaceutical research and development. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in method development, pharmacokinetic studies, and quality control for cinacalcet-based therapeutics.

Application

• Internal Standard for LC-MS/MS: Serves as a stable, non-interfering internal standard for the precise quantification of cinacalcet in biological matrices (plasma, serum, urine) during bioanalytical studies.
• Pharmaceutical R&D: Used in method development and validation for the analysis of cinacalcet hydrochloride in active pharmaceutical ingredients (APIs) and finished drug products.
• Metabolite Studies: Aids in the identification and quantification of cinacalcet metabolites in in vitro and in vivo metabolism studies.
• Quality Control & Assurance: Enables accurate assay and impurity profiling of cinacalcet APIs, ensuring batch-to-batch consistency and compliance with regulatory specifications.
• Clinical Trial Support: Essential for generating reliable pharmacokinetic (PK) and pharmacodynamic (PD) data in clinical trials for drugs targeting the calcium-sensing receptor.

Basic Information

Product Name	Rac Cinacalcet-D3 Hydrochloride
CAS No.	1185097-33-9
Molecular Formula	C22H19D3F3N • HCl
Molecular Weight	405.89 g/mol (for free base C22H19D3F3N)
Synonyms	N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-D3-propan-1-amine Hydrochloride; Cinacalcet-d3 Hydrochloride; (Rac)-Cinacalcet-d3 HCl; AMG 073-d3 Hydrochloride; Sensipar-d3 (deuterated); NPS R-568-d3 Hydrochloride; Calcimimetic-d3 Hydrochloride
EINECS	Contact for details

Quality Control

Our Rac Cinacalcet-D3 Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for chemical purity, NMR and MS for structural confirmation and isotopic enrichment, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, assay, and impurity profiles. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standard applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98 atom % D
Assay (on dried basis)	97.0% - 103.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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