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| Molecular weight: | 1084.2 (free peptide) | |
|---|---|---|
| Sequence: |
__________________________ | | H-Cys-Tyr-Phe-Glu(NH2)-Asp(NH2)-Cys-Pro-Arg-Gly-NH2 |
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| Last update: | 30 AUG 2007 | |
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Available registration documents (CTD format): None, the substance is sold based on its CoA 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 amorphous powder. A solution of the material in water must be clear and colourless. |
Visual inspection |
| IDENTIFICATION | ||
| Identification, HPLC |
Retention time of the sample must be approximately the same as the retention time of the reference |
USP |
| Amino acid analysis |
Asp: 0.9 to 1.1 |
In-house |
| PURITY | ||
| Peptide purity, HPLC: | < 95% | USP |
| ASSAY | ||
| Potency, HPLC | ≥ 300 IU/mg | USP |
| OTHER TESTS | ||
| Acetic acid | ≤ 15% | In-house |
| Water | ≤ 8% | USP/Ph.Eur. |
| Trifluoroacetic acid | < 0.3% | In-house |
| RESIDUAL SOLVENTS | ||
| Ethanol | ≤ 0.5% | In-house |
| Methanol | ≤ 0.3% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | < 200 CFU/g | Ph.Eur. |
| Bacterial endotoxins |
≤ 17.0 IU endotoxin/IU vasopressin |
USP/Ph.Eur. |
