Cyclobenzaprine
General Information
Cyclobenzaprine Impurities and Cyclobenzaprine
Daicel Pharma is a reliable source in synthesizing the best-quality Cyclobenzaprine impurities, such as Cyclobenzaprine 10,11-Epoxide and N-nitroso Cyclobenzaprine. They are vital for evaluating the quality, stability, and biological safety of Cyclobenzaprine. Furthermore, Daicel Pharma specializes in the custom synthesis of Cyclobenzaprine impurities and ensures their global delivery.
Cyclobenzaprine [CAS: 303-53-7] is a tricyclic amine compound acting as an antidepressant. It reduces skeletal muscle hyperactivity. It is usually used for short periods to relieve muscle spasms caused by acute, painful musculoskeletal conditions.
Cyclobenzaprine: Use and Commercial Availability
Cyclobenzaprine treats painful muscle spasms in patients. It is a skeletal muscle relaxant. It improves the range of motion in patients by decreasing localized pain and tenderness. In addition, it acts as a centrally-acting depressant. Various manufacturers prepare Cyclobenzaprine. However, Cyclobenzaprine is available under Amrix and Flexeril as an oral formulation.
Cyclobenzaprine Structure and Mechanism of Action
The chemical name of Cyclobenzaprine is 3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine. The chemical formula for Cyclobenzaprine is C20H21N, and its molecular weight is approximately 275.39 g/mol.
As a skeletal muscle relaxant, Cyclobenzaprine does not interfere with muscle functions. It acts within the central nervous system.
Cyclobenzaprine Impurities and Synthesis
While synthesizing Cyclobenzaprine1, impurities may form that will affect the safety and efficacy of the drug. They form during the synthetic process, purification, or storage of Cyclobenzaprine. Controlling and monitoring Cyclobenzaprine impurities is essential during the drug development process.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Cyclobenzaprine impurities, which includes Cyclobenzaprine 10,11-Epoxide and N-nitroso Cyclobenzaprine. Daicel Pharma offers CoA from a cGMP-compliant analytical facility. It provides complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional analytical data on request. Daicel Pharma can prepare any unidentified Cyclobenzaprine impurity or degradation product. Further, Daicel Pharma offers a highly purified, stable isotope-labeled standard of Cyclobenzaprine. The clients of Daicel Pharma can expect a complete characterization report on delivery.
References
FAQ's
References
- Wendler, Norman L., 5 -(ω-Aminoalkylidene)-5H-dibenzo[a,d]cycloheptenes, BE633316A, June 6, 1963, Merck & Co., Inc. (https://worldwide.espacenet.com/patent/search/family/000200918/publication/BE633316A?q=BE633316)
- Heinitz, Maxine L., Determination of cyclobenzaprine in tablets by high-performance liquid chromatography, Journal of Pharmaceutical Sciences, Volume: 71, Issue: 6, Pages: 656-8, 1982. DOI: (10.1002/jps.2600710612)
Frequently Asked Questions
2. How do we detect the Cyclobenzaprine impurities in the drug product?
RP-HPLC method can detect the Cyclobenzaprine impurities in the drug product.
3. What causes the degradation of Cyclobenzaprine?
Oxidation of the double bonds and tertiary amine group causes the degradation of Cyclobenzaprine.
4. Which analytical method determines the presence of Cyclobenzaprine degradation products in the drug product?
LC-MS is the analytical method that determines the presence of Cyclobenzaprine impurities in the drug product.
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