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| Molecular weight: | 1282.5 (free peptide) | |
|---|---|---|
| Sequence: |
p-Glu-His-Trp-Ser-Tyr-D-Trp- Leu-Arg-Pro-NHEt, supplied as acetate salt |
|
| Last update: | 30 AUG 2007 | |
|
Available registration documents (CTD format): EU and US DMF Please note that regional minor differences in analytical procedures and acceptance criteria might occur. |
||
| TEST | ACCEPTANCE CRITERIA | ANALYTICAL PROCEDURE |
|---|---|---|
| CHARACTERS | ||
| Appearance | White to off-white 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 |
Ser: 0.8 to 1.1 |
Ph.Eur. |
| Identification, HPLC |
Co-elutes with reference standard |
In-house |
| PURITY | ||
| Peptide purity, HPLC: | ≥ 98.5% | In-house |
| Related substances, HPLC: | In-house | |
| [D-pGlu1]Deslorelin | ≤ 0.5% | |
| [D-His2]Deslorelin | ≤ 0.5% | |
| Ser(Ac)4-Deslorelin | ≤ 0.5% | |
| Any other individual impurity | ≤ 0.3% | |
| Total amount | ≤ 1.5% |
| ASSAY | ||
|---|---|---|
| Mass balance | 95 to 105% | Calculation |
| OTHER TESTS | ||
| Acetic acid | ≤ 12% | In-house |
| Water | ≤ 4% | USP/Ph.Eur. |
| Specific optical rotation [α]20D (c = 0.1, 1% acetic acid) |
-70 to -82 (corrected for peptide content) |
Ph.Eur. |
| Trifluoroacetic acid | ≤ 0.3% | In-house |
| Inorganic fluoride | ≤ 0.1% | In-house |
| pH (1% w/V in water) | 4.0 to 6.0 | USP |
| RESIDUAL SOLVENTS | ||
| Any individual residual solvent | ≤ 0.1% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | ≤ 100 CFU/g | Ph.Eur. |
| Bacterial endotoxins |
< 2 IU/mg |
USP/Ph.Eur. |
