Salmon calcitonin is a peptide medicinal hormone composed of 32 amino acids, and is one of the first choice drugs for the treatment of osteoporosis in clinical practice. It has multiple effects such as reducing blood calcium, expanding blood vessels, and neurotransmitters in the central system. It is mainly used in clinical practice for the treatment of elderly osteoporosis, postmenopausal osteoporosis, migraine, and hypercalcemia, especially in the treatment of combined fractures. It also has a good analgesic effect.

Salmon calcitonin was first approved by the US FDA in March 1991 by Novartis AG in Switzerland under the trade name Miacalcin.The drug is still widely used today. However, due to the early use of salmon calcitonin, the research on its impurities was not carried out in the early stage, and there were few reports on its related substances. The impurity spectra of different manufacturers are even different. Whether these impurities have activity, and whether their activities in vitro and in vivo are related are issues that need to be explored

The production process of salmon calcitonin mainly adopts a solid-state synthesis method, which fixes the C-terminal of amino acids on an insoluble resin, and then condenses amino acids on this resin in turn. After repeated operations of condensation, washing, deprotection, neutralization, washing, and the next round of condensation, the desired length of the peptide chain is reached. Finally, the peptide chain is split off the resin, and preliminary purification treatment is conducted to obtain a crude salmon calcitonin product, which is then purified and refined, Obtain salmon calcitonin raw material. Salmon calcitonin can be made into injection or powder injection by adding appropriate auxiliary materials. Clinically used calcitonin injections include injection, powder injection, and nasal spray. Due to its complex amino acid composition and many synthesis steps, the drug has the characteristics of instability and easy degradation, and the composition of impurities is relatively complex.

Salmon Calcitonin Sequence

Cys-Ser-Asn-Leu-Ser-Thr-Cys-Val-Leu-Gly-Lys-Leu-Ser-Gln-Glu-Leu-His-Lys-Leu-Gln-Thr-Tyr-Pro-Arg-Thr-Asn-Thr-Gly-Ser-Gly-Thr-Pro-NH2

Click to learn Salmon Calcitonin impurities lists:

Due to their unique advantages in activity, polypeptide drugs have received widespread attention in recent years. The European Pharmacopoeia 7.0 has stipulated reporting limits, identification limits, and quality control limits for impurities in synthetic polypeptide drugs to be 0.1%, 0.5%, and 1.0%, respectively. According to the literature research on salmon calcitonin, there are more literature reports on pharmacology, clinical effects, safety, toxicity, and other aspects, while there are fewer reports on its quality control and impurity mass spectrometry. Studies on known impurities in salmon calcitonin have been reported in the literature. In the European Pharmacopoeia 7.0, four impurities are listed as A, B, C, and D, respectively: N-acetylcysteine salmon calcitonin, 9-D leucine salmon calcitonin, des-22-tyrosine salmon calcitonin, and O-acetyl salmon calcitonin

Due to the same drug produced by different production processes, its impurity mass spectra and impurity levels are different. Salmon calcitonin, as a synthetic polypeptide drug, has the characteristics of instability and easy degradation. The commonly used dosage forms are injection, sterile powder for injection, nasal spray, etc. Due to its early use, research on its impurities has not been carried out in the early stage, and there are few reports on its related substances. Domestic and foreign literature has reported on the degradation products in its aqueous solution, The degradation products of salmon calcitonin in aqueous solution at different pH (3-6) are different.

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Artcle from Custom Peptide Impurity Synthesis India | Omizzur