Salmon Calcitonin Impurities, Peptide Impurities

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.

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

5.Others

β- Asp salmon calcitonin

γ- Glu salmon calcitonin

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.