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| Molecular weight: | 988 | |
|---|---|---|
| Sequence: |
CH2 -------- CH2 --------- S --------- CH2 | | CH2-CO-Tyr(Me)-Ile-Gln-Asn-HN-CH- CO-Pro-Leu-Gly-NH2 |
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| Last update: | 12 SEP 2007 | |
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Available registration documents (CTD format): Contact PolyPeptide Laboratories 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 |
Complies with reference |
In-house |
| Amino acid analysis |
Asp: 0.95 to 1.05 |
Ph.Eur. |
| PURITY | ||
| Related substances, HPLC: | In-house | |
| [D-Cy6]carbetocin | ≤ 1.0% | |
| [D-Asn5]carbetocin | ≤ 1.0% | |
| Carbetocin sulfoxide I | ≤ 0.3% | |
| Carbetocin sulfoxide II | ≤ 0.4% | |
| [isoAsn5]carbetocin | ≤ 0.5% | |
| Any other individual impurity | ≤ 0.3% | |
| Sum of other impurities | ≤ 1.0% | |
| Total amount | ≤ 3.5% |
| ASSAY | ||
|---|---|---|
| Peptide content | ≥ 85% | In-house |
| Mass balance | 95 to 105% | In-house |
| OTHER TESTS | ||
| Specific optical rotation [α]25D | -81 to -71 | In-house |
| Acetic acid | ≤ 5% | In-house |
| Water | ≤ 6.0% | Ph.Eur. |
| RESIDUAL SOLVENTS | ||
| Methanol | ≤ 0.3% | Ph.Eur. |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | ≤ 100 CFU/g | USP/Ph.Eur. |
| Bacterial endotoxins |
< 2000 IU/mg |
USP/Ph.Eur. |
