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| Molecular weight: | 1039 | |
|---|---|---|
| Sequence: |
___________________ | | H-Cys-Phe-Phe-Gln-Asn-Cys-Pro-Lys-Gly-NH2 Acetate salt |
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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 or almost white powder or flakes |
Visual inspection |
| IDENTIFICATION | ||
| Identification, HPLC |
Retention time conforms to that of reference |
Ph.Eur. |
| Amino acid analysis |
Asp: 0.9 to 1.1 |
Ph.Eur. |
| PURITY | ||
| Peptide purity | ≤ 97.0% | Ph.Eur. |
| Related substances, HPLC: | Ph.Eur. | |
| [Cys1(Acm),Cys6(Acm)]- | ≤ 0.5% | |
| Felypressin | ||
| [Asp5]Felypressin | ≤ 0.3% | |
| Dimer(1,6';6,1') | ≤ 0.5% | |
| Dimer(1,1';6,6') | ≤ 0.5% | |
| [Ac-Cys1]Felypressin | ≤ 0.5% | |
| Any other individual impurity | ≤ 0.1% | |
| Total amount | ≤ 3.0% |
| ASSAY | ||
|---|---|---|
| Mass balance | 95.0 to 102.0% | Calculation |
| OTHER TESTS | ||
| Water | ≤ 7.0% | USP |
| Specific optical rotation | -35 to -29 | USP/Ph.Eur. |
| Acetic acid | ≤ 9.0 to 13.0% | Ph.Eur. |
| Trifluoroacetic acid | < Trifluoroacetic acid | In-house |
| RESIDUAL SOLVENTS | ||
| Ethanol | ≤ 5000 ppm | In-house |
| Ethanol | ≤ 3000 ppm | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | < 100 CFU/g | Ph.Eur. |
| Bacterial endotoxins |
< 100 IU/mg |
Ph.Eur. |
