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| Molecular weight: | 1209.4 (free peptide) | |
|---|---|---|
| Sequence: |
p-Glu-His-Trp-Ser-Tyr-D-Leu- Leu-Arg-Pro-NHEt |
|
| Last update: | 30 AUG 2007 | |
|
Available registration documents (CTD format): CEP/COS certificate 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 | A hygroscopic, white or almost white powder |
Visual inspection |
| Solubility | Soluble in water and 1% (V/V) aqueous acetic acid at a concentration of ≥ 10 mg/mL to give a clear, colorless solution |
Ph.Eur. |
| IDENTIFICATION | ||
| Identification, MS |
Monoisotopic mass |
Ph.Eur. |
| Amino acid analysis |
Ser: Present |
Ph.Eur. |
| Identification, HPLC |
Co-elutes with reference standard |
Ph.Eur. |
| PURITY | ||
| Peptide purity, HPLC: | ≥ 97.5% | Ph.Eur. |
| Related substances, HPLC: | Ph.Eur. | |
| O-acetyl-Ser-Leuprolide | ≤ 1% | |
| Any individual impurity | ≤ 0.5% | |
| Total amount | ≤ 2.5% |
| ASSAY | ||
|---|---|---|
| Mass balance | 97.0 to 103.0% | Calculation |
| OTHER TESTS | ||
| Acetic acid | 4.7 to 9.0% | In-house |
| Water | ≤ 5.0% | USP/Ph.Eur. |
| Specific optical rotation [α]20D (c = 1, 1% acetic acid) |
-38 to -42 | Ph.Eur. |
| Trifluoroacetic acid | ≤ 0.1% | In-house |
| Inorganic fluoride | ≤ 0.05% | In-house |
| Residue on ignition | ≤ 0.3% | USP |
| RESIDUAL SOLVENTS | ||
| Any individual residual solvent | ≤ 0.1% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | Report value (CFU/g) | In-house |
| Bacterial endotoxins |
< 16.7 IU/mg |
USP/Ph.Eur. |
