| 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
