Goserelin specifications
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| Molecular weight: | 1269.4 (free peptide) | |
|---|---|---|
| Goserelin Sequence: |
p-Glu-His-Trp-Ser-Tyr-D-Ser(tBu)- Leu-Arg-Pro-AzaGly-NH2, supplied as acetate salt |
|
| Last update: | 30 AUG 2007 | |
| Available registration documents (CTD format): Contact PolyPeptide Group 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 powder of low density
|
Visual inspection |
| Solubility |
Soluble in water at a concentration of 30% (w/w) to give a clear, colorless solution. Time to gelling is > 15 minutes.
|
In-house |
| IDENTIFICATION | ||
| Identification, MS |
Monoisotopic mass
1268.6 ± 1 |
In-house |
| Amino acid analysis |
Ser: 1.7 to 2.3
Glx: 0.85 to 1.15 Pro: 0.85 to 1.15 AzaGly: Not detected Leu: 0.85 to 1.15 Tyr: 0.85 to 1.15 His: 0.85 to 1.15 Trp: Present Arg: 0.85 to 1.15 |
In-house |
| Identification, HPLC |
Co-elutes with reference standard
System I and II |
In-house |
Other specifications of Goserelin:PURITY |
||
| Peptide purity, HPLC: | ≥ 97% System I and II |
In-house |
| Related substances, HPLC: | ||
| Total amount | ≤ 3% | |
| Any individual impurity | ≤ 1% | |
| System I and II | In-house |
| ASSAY | ||
|---|---|---|
| Mass balance | 95 to 105% | Calculation |
| OTHER TESTS | ||
| Acetic acid | ≤ 12% | In-house |
| Water | ≤ 10% | USP/Ph.Eur. |
| Specific optical rotation [α]20D (c = 1.0, 1% acetic acid) |
Report value (corrected for peptide content) | In-house |
| Trifluoroacetic acid | ≤ 0.25% | In-house |
| RESIDUAL SOLVENTS | ||
| Any individual residual solvent | ≤ 0.1% | In-house |
