Cinacalcet
General Information
Cinacalcet Impurities and Cinacalcet
Daicel Pharma synthesizes Cinacalcet impurities of exceptional quality, such as Cinacalcet Diastereomer-1 (Hydrochloride Salt) and Cinacalcet Diastereomer-2 (Hydrochloride Salt). These impurities are crucial to assess the purity, reliability, and safety of an active pharmaceutical ingredient, Cinacalcet. Besides, Daicel Pharma provides custom synthesis of Cinacalcet impurities to meet clients’ demands for delivery worldwide.
Cinacalcet [CAS: 226256-56-0] is an agonist of the Calcium-sensing Receptor and functions as a calcimimetic and a P450 inhibitor. It treats hyperparathyroidism resulting from parathyroid tumors or renal failure.
Cinacalcet: Use and Commercial Availability
Cinacalcet is a medication for the management and treatment of various conditions, including secondary hyperparathyroidism in patients undergoing dialysis, primary hyperparathyroidism for individuals who are not suitable candidates for surgery, and calciphylaxis in patients with advanced kidney disease or receiving dialysis. Cinacalcet can be utilized in cases of primary hyperparathyroidism when surgical intervention poses a high risk or is not feasible. Cinacalcet Hydrochloride and Sensipar are among the brand names under which Cinacalcet is available in drug formulations.
Cinacalcet Structure and Mechanism of Action 
The chemical name of Cinacalcet is N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine. Its chemical formula is C22H22F3N, and its molecular weight is approximately 357.4 g/mol.
Cinacalcet lowers parathyroid hormone (PTH) levels by increasing the sensitivity of the calcium-sensing receptor to extracellular calcium.
Cinacalcet Impurities and Synthesis
During the synthesis1, storage, or degradation of Cinacalcet, an agonist of the Calcium-sensing Receptor, impurities may develop. They result from various factors, including starting materials, reagents, intermediates, or undesired side reactions. The analysis and control of Cinacalcet impurities are essential to ensure the drug’s quality, safety, and efficacy. Impurity analysis allows for identifying and quantifying substances, enabling manufacturers to establish acceptable limits and implement measures to control impurity levels. By maintaining strict control over impurities, the purity and effectiveness of Cinacalcet can be ensured, minimizing potential risks and maintaining patient safety.
Daicel Pharma offers a Certificate of Analysis (CoA) for Cinacalcet impurity standards, such as Cinacalcet Diastereomer-1 (Hydrochloride Salt) and Cinacalcet Diastereomer-2 (Hydrochloride Salt), generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Furthermore, on request, we give additional data like 13C-DEPT and CHN. Daicel Pharma can create unknown Cinacalcet impurities or degradation products. A complete characterization report accompanies every delivery.
References
FAQ's
References
- Van Wagenen, Bradford C.; Moe, Scott T.; Balandrin, Manuel F.; Delmar, Eric G.; Nemeth, Edward F., Calcium receptor-active compounds, NPS Pharmaceuticals, Inc., United States, US6211244B1, April 3, 2001
- Ravinder, Vadde; Ashok, Sigala; Varma, M. Satish; Babu, C. V. Raghunath; Shanker, Kanne; Balaswamy, Gubba, A validated chiral LC method for the enantiomeric separation of cinacalcet hydrochloride, Chromatographia, Volume: 70, Issue: ½, Pages: 229-232, 2009
Frequently Asked Questions
How does impurity analysis contribute to the quality assurance of Cinacalcet?
Impurity analysis ensures that Cinacalcet meets quality standards, regulatory requirements, and patient safety expectations, enhancing its quality assurance.
Are impurity profiles different among different brands of Cinacalcet?
The impurity profiles may vary among different brands of Cinacalcet due to variations in manufacturing processes, starting materials, or formulation techniques.
Which solvent helps in the analysis of Cinacalcet impurities?
Methanol is a solvent used in analyzing many impurities in Cinacalcet.
What are the temperature conditions required to store Cinacalcet impurities?
Cinacalcet impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.