Loratadine Impurities
General Information
Loratadine Impurities and Loratadine
Daicel Pharma offers high-quality Loratadine impurities, such as Methanone.HCl Regio isomer. They are vital for evaluating Loratadine quality, stability, and biological safety. Furthermore, Daicel Pharma specializes in the custom synthesis of Loratadine impurities and ensures their worldwide delivery.
Loratadine [CAS: 79794-75-5], an azatadine derivative, is an antihistamine. It treats and manages allergic rhinitis and urticaria. Loratadine is a non-sedating, long-acting tricyclic histamine H1-receptor antagonist. It is a second-generation antihistamine with anti-allergic properties.
Loratadine: Use and Commercial Availability
Loratadine is a piperidine derivative and a US FDA-approved drug. It treats allergic rhinitis and allergic skin rashes. It provides relief to patients suffering from seasonal allergies. At present, Loratadine is an OTC (over-the-counter) drug. It is administered orally to patients. There are many generic manufacturers of Loratadine. Loratadine is available as Alavert, Claritin, Claritin Reditabs, Claritin Redidose, Claritin Hives Relief, and more.
Loratadine Structure and Mechanism of Action
The chemical name of Loratadine is Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate. The chemical formula for Loratadine is C22H23ClN2O2 and its molecular weight is approximately 382.88 g/mol.
Loratadine blocks histamine H1-receptors present in respiratory smooth muscle cells. It causes a reduction in vascular permeability in various cells.
Loratadine Impurities and Synthesis
During the synthesis of Loratadine1, impurities may form that may affect the safety and efficacy of the drug. These impurities form during the synthesis, storage, or degradation of Loratadine. As a result, impurities must be controlled and monitored throughout the drug’s lifecycle.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Loratadine impurities, which includes Methanone.HCl Regio isomer. The CoA is from a cGMP-compliant analytical facility and encompasses complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional data like 13C-DEPT and CHN on request. Daicel Pharma can prepare any unidentified Loratadine impurity or degradation product. In addition, Daicel Pharma offers highly purified isotope-labeled standards of Loratadine for bioanalytical research and BA/BE studies. We also provide a complete characterization report on delivery.
References
FAQ's
References
- Vilani, Frank J., Antihistaminic 11-(4-piperidylidene)-5H-benzo-[5,6]-cyclohepta-[1,2-b]-pyridines, US4282233A, Aug 4, 1981, Schering Corp
- Johnson, Richard; Christensen, Jeffrey; Lin, Chin-Chung, Sensitive gas-liquid chromatographic method for the determination of loratadine and its major active metabolite, descarboethoxyloratadine, in human plasma using a nitrogen-phosphorus detector, Journal of Chromatography B: Biomedical Sciences and Applications, Volume: 657, Issue: 1, Pages: 125-31, 1994 DOI: (10.1016/0378-4347(94)80078-2)
Frequently Asked Questions
What is the analytic method to detect and isolate unknown impurities of Loratadine?
Reversed-phase high-performance liquid chromatography (HPLC) is the analytical method to detect and isolate unknown impurities of Loratadine.
How do Loratadine impurities form in pharmaceutical processes?
By-products during the synthetic process, unreacted starting materials, and residual solvents form Loratadine impurities.
How can the formation of Loratadine impurities be minimized during synthesis?
The formation of Loratadine impurities can be minimized by optimizing the synthetic process, using high-quality raw materials, and maintaining strict quality control measures.
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.