Product name | Teduglutide |
Product No. | 600865 |
Sequence | His-Gly-Asp-Gly-Ser-Phe-Ser-Asp-Glu-Met-Asn-Thr-Ile-Leu-Asp-Asn-Leu-Ala-Ala-Arg-Asp-Phe-Ile-Asn-Trp-Leu-Ile-Gln-Thr-Lys-Ile-Thr-Asp |
Appearance | White or off-white powder |
Solubility | Sparingly soluble in water |
Identify[HPLC] | The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution |
Water | ≤8.0% |
HPLC | The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution. |
Amino acid analysis | Asp 7.2-8.8 Thr 2.7-3.3 |
Ser 1.6-2.0 Glu 1.8-2.2 | |
Gly 1.8-2.2 Ala 1.8-2.2 | |
Met 0.9-1.1 Ile 3.6-4.4 | |
Leu 2.7-3.3 Phe 1.8-2.2 | |
Lys 0.9-1.1 His 0.9-1.1 | |
Arg 0.9-1.1 | |
Related substances | Any impurity: NMT 1.0% Total impurity: NMT 2.0% |
Assay | 95.0%-105.0%(anhydrous and acetic acid free substance) |
Acetate acid | ≤5.0% |
MS | 3752.1±1.0 |
Storage Condition | In an air tight container, protected from light at temperature 2-8℃. |
Application field: Teduglutide is a glucagon-like peptide-2 (GLP-2); regeneration, maintenance, and repair of the intestine