Salmon calcitonin is a peptide drug containing 32 amino acids synthesized by solid phase synthesis. It is used as the first choice of the treatment of osteoporosis,especially used for bone fracture treatment. Due to its complex amino acid composition and many synthetic steps, the drug has the characteristics of instability and easy degradation, and the impurity composition is relatively complex. It is necessary to analyze the product, deeply study its impurity mass spectrum, establish an analytical method for the correlation between impurities and biological activity, and comprehensively evaluate the effectiveness and stability of the marketed product, so as to ensure the safe, effective and controllable quality of the drug.
Related substances of salmon calcitonin raw materials were detected by LC-MS technology,determine whether it was a known impurity,determine the structure of them. There are two main process impurities,one is isomers,the other is lack of an asparagine. Omizzur use LC-MS technology,preparation,disulfide bond fracture analysis method to determine the structure of the two injection degradation impurities.The salmon calcitonin impurities may produce include the following categories:
1. Salmon calcitonin impurities with amino acid deficiency
Salmon calcitonin impurity that lacks one amino acid. There are 32 possible impurities, starting with the deletion of N-terminal cysteine and ending with C-terminal proline, such as EP 7.0
Des-22 tyrosine calcitonin . According to the analysis of amino acid properties, acidic amino acids such as aspartic acid and glutamic acid are not easy to condense. Salmon calcitonin is a peptide impurity that lacks two amino acids and may have more types, such as C-terminal glycine threonine deficient Salmon calcitonin
2. Chiral racemic isomers
Some amino acids are prone to racemization during condensation, such as cysteine, serine, lysine, histidine, proline, arginine, and other amino acids. For example, impurity B, 9-D leucine calcitonin salmon in European Pharmacopoeia 7.0
3. Degradable impurities, such as hydrolytic impurities
Some amino acids are relatively easy to hydrolyze, such as asparagine, glutamine, and the amide structure formed by terminal proline is also easy to hydrolyze; Oxidizing impurities, impurities that are oxidized by cysteine, such as impurity D in EP 7.0; Amino acid ring opening impurity, proline ring opening, two proline in salmon calcitonin, easy to open the ring to form 5-aminovaleric acid; N-terminal acetylated impurity, such as impurity A (N-Acetyl-cys1-calcium salt) in EP 7.0
4. Recombinant Salmon Calcitonin Impurities (EP7.0)
Impurity E: Calcitonin salmon-glycine
Impurity F: 1,7-bis (3-sulfo-l-alanine)] calcitonin salmon
Asp salmon calcitonin
Glu salmon calcitonin
High performance liquid chromatography (HPLC) can be used to detect impurities in salmon calcitonin and its injections, compare the impurities in products from different manufacturers, determine the source and structure of impurities using liquid chromatography mass spectrometry, and identify the structure of unknown impurities. An impurity spectrum of salmon calcitonin can be established.
Omizzur Biotech is a custom peptide synthesis company in China. Omizzur provides a series of customized synthesis services for salmon calcitonin impurities, as well as analysis reports ,certificates for HPLC, MS, COA, COO,BSE, etc. Omizzur sign a customer privacy agreement to 100% protect customer privacy . Please contact Omizzur customer services for help.