Arginine
General Information
Arginine Impurities and Arginine
Daicel Pharma offers superior-quality Arginine impurities, such as N2-(Aminocarbonyl)-L-arginine. It is vital for evaluating Arginine quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Arginine impurities and ensures their worldwide delivery.
Arginine [CAS: 7200-25-1] is an essential amino acid. It has extensive applications in the pharmaceutical and biotechnology industries. It is a part of human ribosomal protein synthesis. Its physiologically active form is L-arginine. L-arginine is a micronutrient and a nutraceutical. Further, it is a metabolite of the Escherichia coli strain.
Arginine: Use and Commercial Availability
Arginine acts as a dietary supplement. It has many uses. It regulates blood pressure and immune functions. L-arginine improves endothelium-dependent vasodilation in patients having atherosclerosis. It improves symptoms of cardiovascular diseases in patients. Arginine is essential for collagen synthesis and is critical for wound healing. Further, it is helpful in the production of growth hormone, prolactin, insulin, glucagon, and more. It aids in treating hyperammonemia and is a diagnostic agent of acromegaly and gigantism. Arginine is available as R-Gene 10, an intravenous injection.
Arginine Structure and Mechanism of Action
The chemical name of Arginine is 2-Amino-5-(carbamimidamido)pentanoic acid. The chemical formula for Arginine is C6H14N4O2, and its molecular weight is approximately 174.20 g/mol.
L-arginine converts to nitric oxide and lowers serum cholesterol. It controls vasoconstriction and regulates blood pressure.
Arginine Impurities and Synthesis
While synthesizing Arginine1,2, impurities may form that will affect the safety and efficacy of the drug. These impurities form during Arginine synthesis, purification, storage, or degradation. Arginine impurities need control and monitoring to improve the drug’s safety, efficacy, and storage.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Arginine impurities, which includes N2-(Aminocarbonyl)-L-arginine. A CoA is from a cGMP-compliant analytical facility. It contains the complete characterization data3 such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Arginine impurity or degradation product. In addition, Daicel Pharma offers highly purified stable isotope-labeled standards of Arginine for bioanalytical research and BA/BE studies. A complete characterization report is available on delivery.
References
- Howe, Eugene E.; Tishler, Max, Recovery of arginine, histidine, and lysine from protein hydrolysates, US2480654A, Aug 30, 1949, Merck & Co., Inc.( https://www.lens.org/lens/search/patent/list?q=US2480654A)
- Scopes, P. M.; Walshaw, K. B.; Welford, M.; Young, G. T., Amino acids and peptides. XXI. Removal of the nitro group from nitroarginine and peptides of nitroarginine by electrolytic reduction, Journal of the Chemical Society, Issue: Jan., Pages: 782-6, 1965 DOI: (1039/jr9650000782)
- Hutzler, Joel; Odievre, Michel; Dancis, Joseph, Analysis for lysine, arginine, histidine, and tyrosine in biological fluids, Analytical Biochemistry, Volume: 19, Issue: 3, Pages: 529-41, 1967 DOI: (10.1016/0003-2697(67)90243-6)
Frequently Asked Questions
2.Why is it necessary to identify Arginine impurities in drug substances?
For drug safety, quality, and efficacy, it is necessary to identify Arginine impurities in drug substances.
3.How do we identify unknown Arginine impurities?
LC-MS/MS and HPLC methods help identify unknown Arginine impurities in drugs.
4.What is the source of Arginine impurities?
The sources of Arginine impurities include reagents, ligands, heavy metals, starting materials, by-products, inorganic salts, and degradation products.
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