Gonadorelin, HCI specifications
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| Molecular weight: | 1182.3 (free peptide) | |
|---|---|---|
| Gonadorelin, HCI Sequence: |
p-Glu-His-Trp-Ser-Tyr-Gly-Leu- Arg-Pro-Gly-NH2, supplied as hydrochloride salt |
|
| Last update: | 31 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 free from visible evidence of contamination
|
Visual inspection |
| Solubility |
Soluble in water and 1% acetic acid at a concentration of 10 mg/mL to give a clear, essentially colorless solution
|
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: 0.3 to 1.1 Arg: 0.95 to 1.05 |
In-house |
| Identification, HPLC |
Co-elutes with reference standard
|
USP |
Other specifications of Gonadorelin, HCIPURITY |
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| Peptide purity, HPLC: | ≥ 97.0% | USP |
| Related substances, HPLC: | USP | |
| Total amount | ≤ 3.0% | |
| Any individual impurity | ≤ 2.0% |
| ASSAY | ||
|---|---|---|
| Mass balance | 94.0 to 104.0% | Calculation |
| OTHER TESTS | ||
| Chloride | 4.0 to 6.0% | USP |
| Water | ≤ 7.0% | USP/Ph.Eur. |
| Specific optical rotation [α]20D (c = 1.0, water) |
-57 to -63 (calculated on the anhydrous, chloride-free basis) |
USP |
| Acetic acid | ≤ 1.0% | In-house |
| 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 | In-house |
| Bacterial endotoxins | ≤ 70 IU/mg |
USP/Ph.Eur. |
