Cyclosporine
General Information
Cyclosporine Impurities and Cyclosporine
Daicel Pharma is a reliable source in synthesizing excellent-quality Cyclosporine impurities and labeled standards. They are vital for evaluating the quality, stability, and biological safety of Cyclosporine. Furthermore, Daicel Pharma specializes in the custom synthesis of Cyclosporine impurities and ensures their global delivery.
Cyclosporine [CAS: 59865-13-3] is a cyclic decapeptide. It is an immunosuppressant agent with anti-inflammatory properties. It is a cytochrome P450 2A4 inhibitor and blocks P-glycoproteins. It helps in the treatment of organ rejection after transplant. It also treats patients with graft vs. host disease (GVHD).
Cyclosporine: Use and Commercial Availability
As an immunosuppressive agent, Cyclosporine has many uses. It treats organ rejection in liver, kidney, and heart transplants. Further, it treats patients with amyotrophic lateral sclerosis (ALS). It is a part of the treatment therapy for psoriasis, rheumatoid arthritis, and nephrotic syndrome when patients are not responding to the drugs. It also acts in autoimmune diseases. Its administration is through oral or intravenous methods. Cyclosporine is available under Cequa, Restasis, Sandimmune, Verkazia, Vevye, etc.
Cyclosporine Structure and Mechanism of Action
The chemical formula for Cyclosporine is C62H111N11O12, and its molecular weight is approximately 1202.61 g/mol.
Cyclosporine blocks interleukin synthesis, specifically IL-2. Interleukins are responsible for the self-activation and differentiation of T lymphocytes. It suppresses cell-mediated immune reactions.
Cyclosporine Impurities and Synthesis
During Cyclosporine synthesis1, impurities form that may affect the safety and efficacy of the drug. The impurities form during the synthetic process, purification, or storage of Cyclosporine. They must be controlled and monitored throughout the drug development process.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Cyclosporine impurities and labeled standards. 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 Cyclosporine impurity or degradation product. In addition, Daicel Pharma offers a highly purified, stable deuterium-labeled standard Cyclosporine Labelled Standard. The clients of Daicel Pharma can expect a complete characterization report on delivery.
References
- Haerri, Eugen; Rueegger, Artur, Organic compounds, US4117118A, Mar 29, 1977, Sandoz A.-G., Switzerland (https://www.lens.org/lens/search/patent/list?q=US4117118)
- Niederberger, W.; Schaub, P.; Beveridge, T., High-performance liquid chromatographic determination of cyclosporin A in human plasma and urine, Journal of Chromatography, Biomedical Applications, Volume: 182, Issue: 3-4, Pages: 454-8, 1980 DOI: (10.1016/s0378-4347(00)81500-5)
Frequently Asked Questions
2. Which analytical method separates the major degradation products of Cyclosporine from the drug product?
Cyclodextrin-modified micellar electrokinetic chromatography (CD-MEKC). is the analytical method that separates the major degradation products of Cyclosporine from the drug product.
3. How do we detect the degradation products and impurities of Cyclosporine in the drug product?
HPLC method can detect the degradation products and impurities of Cyclosporine in the drug product.
4. Why is it necessary to eliminate the Cyclosporine degradation products and impurities from the drug?
Cyclosporine degradation products and impurities affect drug safety and human health. And so, it is necessary to eliminate them from the drug.
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