Gonadorelin Acetate specifications
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| Molecular weight: | 1182.3 (free peptide) | |
|---|---|---|
| Gonadorelin Acetate Sequence: |
p-Glu-His-Trp-Ser-Tyr-Gly-Leu- Arg-Pro-Gly-NH2, 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 at a concentration of 10 mg/mL to give a clear solution not more intensely colored than reference solution Y5
|
Ph.Eur. |
| IDENTIFICATION | ||
| Identification, MS |
Monoisotopic mass
1181.6 ± 1 |
In-house |
| Amino acid analysis |
Ser: 0.7 to 1.05
Glx: 0.95 to 1.05 Pro: 0.95 to 1.05 Gly: 1.9 to 2.1 Leu: 0.9 to 1.1 Tyr: 0.7 to 1.05 His: 0.95 to 1.05 Trp: Present Arg: 0.95 to 1.05 Isoleucine and Lysine absent; not more than traces of other amino acids exept Tryptophan |
Ph.Eur. |
| Identification, HPLC |
Co-elutes with reference standard
System I System II |
In-house Ph.Eur. |
| Other specifications of Gonadorelin Acetate: PURITY |
||
| Peptide purity, HPLC: | ≥ 98% | |
| System I | In-house | |
| System II | Ph.Eur. | |
| Related substances, HPLC: | ||
| Total amount | ≤ 2% | |
| Any individual impurity | ≤ 1% | |
| System I | In-house | |
| System II | Ph.Eur. |
| ASSAY | ||
|---|---|---|
| Mass balance | 95.0 to 102.0% | Calculation |
| OTHER TESTS | ||
| Acetic acid | 8.0 to 12.5% | Ph.Eur. |
| Water | ≤ 7.0% | USP/Ph.Eur. |
| Specific optical rotation [α]20D (c = 1.0, 1% acetic acid) |
-54 to -66 (corrected for peptide content) |
Ph.Eur. |
| Light absorption (278 nm, 0.1 mg/mL in water) |
0.55 to 0.61 (corrected for peptide content) |
Ph.Eur. |
| Trifluoroacetic acid | ≤ 0.25% | In-house |
| Inorganic fluoride | ≤ 0.1% | In-house |
| RESIDUAL SOLVENTS | ||
| Any individual residual solvent | ≤ 0.1% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | ≤ 300 CFU/g | Ph.Eur. |
| Bacterial endotoxins | ≤ 70 IU/mg |
USP/Ph.Eur. |
