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| Molecular weight: | 1019.3 (free peptide) | |
|---|---|---|
| Sequence: |
___________________ | | H-D-Phe-Cys-Phe-D-Trp-Lys-Thr-Cys-Thr(ol), supplied as acetate salt |
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| Last update: | 30 AUG 2007 | |
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Available registration documents (CTD format): EU and US DMF 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 to off-white amorphous powder |
Visual inspection |
| Solubility | Soluble in water and 1% acetic acid at a concentration of ≥ 1 mg/mL to give a clear, colorless solution |
Ph.Eur. |
| IDENTIFICATION | ||
| Identification, MS |
Monoisotopic mass |
Ph.Eur. |
| Amino acid analysis |
Thr: 0.9 to 1.1 |
Ph.Eur. |
| Identification, HPLC |
Co-elutes with reference standard |
In-house |
| PURITY | ||
| Peptide purity, HPLC: | ≥ 98% | In-house |
| Related substances, HPLC: | In-house | |
| Total amount | ≤ 2% | |
| Any individual impurity | ≤ 0.5% |
| ASSAY | ||
|---|---|---|
| Mass balance | 95 to 105% | Calculation |
| OTHER TESTS | ||
| Acetic acid | 7.6 to 12.8% (corrected for water content) |
In-house |
| Water | ≤ 10% | USP/Ph.Eur. |
| Specific optical rotation [α]20D (c = 0.5, 1% acetic acid) |
-17 to -21 (corrected for peptide content) |
Ph.Eur. |
| Trifluoroacetic acid | ≤ 0.25% | In-house |
| Inorganic fluoride | ≤ 0.1% | In-house |
| pH of solution (10 mg/mL in water) | 5 to 7 | USP |
| RESIDUAL SOLVENTS | ||
| Any individual residual solvent | ≤ 0.1% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | ≤ 300 CFU/g | In-house |
| Bacterial endotoxins |
< 1 IU/mg |
USP/Ph.Eur. |
