Carbetocin specifications
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| Molecular weight: | 988 | |
|---|---|---|
| Carbetocin Sequence: |
CH2 -------- CH2 --------- S --------- CH2 | | CH2-CO-Tyr(Me)-Ile-Gln-Asn-HN-CH- CO-Pro-Leu-Gly-NH2 |
|
| Last update: | 25 OCT 2010 | |
| Available registration documents (CTD format): Contact the PolyPeptide Group Please note that regional minor differences in analytical procedures and acceptance criteria might occur. |
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| TEST | ACCEPTANCE CRITERIA | ANALYTICAL PROCEDURE |
|---|---|---|
| CHARACTERS | ||
| Appearance |
White fluffy powder
|
Visual inspection |
| IDENTIFICATION | ||
| Identification, HPLC |
Retention time and peak shape
of main peak corresponds to that of reference |
Internal |
| Amino acid analysis |
Asp: 0.95 - 1.05
Glu: 0.95 - 1.05 Pro: 0.95 - 1.05 Gly: 0.95 - 1.05 Ile: 0.95 - 1.05 Leu: 0.95 - 1.05 Tyr: 0.95 - 1.05 Cys C3 present |
Ph.Eur., USP |
Other specifications of Carbetocin:ASSAY |
||
| Peptide content, HPLC | ≥ 85% | Internal |
| Peptide content, mass balance (HPLC) |
95 - 105% of free base in % of the anhydrous and acetic acid free substance |
Internal |
| PURITY | ||
|---|---|---|
| Any unspecified impurities | ≤ 0.3% | Internal |
| Sum of all impurities | ≤ 3.5% | |
| Sum of unspecified impurities | ≤ 1.0% | |
| Specified impurities: | ||
| [D-Cys6]carbetocin | ≤ 1.0% | |
| [D-Asn5]carbetocin | ≤ 1.0% | |
| Carbetocin sulfoxide I | ≤ 0.3% | |
| Carbetocin sulfoxide II | ≤ 0.4% | |
| OTHER TESTS | ||
|---|---|---|
| Specific optical rotation [α]25D | -81 to -71 | Ph. Eur., USP |
| Acetic acid content | ≤ 5% | Internal |
| Water content | ≤ 6.0% | Ph.Eur., USP |
| RESIDUAL SOLVENTS | ||
| Dimetylformamide | ≤ 880 ppm | Internal |
| Acetonitrile | ≤ 410 ppm | Internal |
| MICROBIOLOGICAL TESTS | ||
| TAMC | ≤ 100 CFU/g | Ph.Eur., USP |
| TYMC | ≤ 100 CFU/g | Ph.Eur., USP |
| Bacterial Endotoxins | ≤ 2000 EU/mg |
Ph.Eur., USP |
