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| Molecular weight: | 4117.8 (free peptide) | |
|---|---|---|
| Sequence: |
H-Ser-Val-Ser-Glu-Ile-Gln-Leu- Met-His-Asn-Leu-Gly-Lys-His-Leu- Asn-Ser-Met-Glu-Arg-Val-Glu-Trp- Leu-Arg-Lys-Lys-Leu-Gln-Asp-Val- His-Asn-Phe-OH, supplied as acetate salt |
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| Last update: | 30 AUG 2007 | |
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Available registration documents (CTD format): Contact PolyPeptide Laboratories 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 |
Visual inspection |
| Solubility | Soluble in 1% acetic acid at a concentration of 1 mg/mL to give a clear, colorless solution |
Ph.Eur. |
| IDENTIFICATION | ||
| Identification, MS |
Monoisotopic mass |
In-house |
| Amino acid analysis |
Asx: 3.6 to 4.4 |
In-house |
| Identification, HPLC |
Co-elutes with reference standard |
In-house |
| PURITY | ||
| Peptide purity, HPLC: | ≥ 98.5% System I and XI |
In-house |
| Related substances, HPLC: | ||
| Total amount | ≤ 1.5% | |
| Any individual impurity | ≤ 0.5% | |
| System I and XI | In-house |
| ASSAY | ||
|---|---|---|
| Mass balance | 95 to 105% | Calculation |
| OTHER TESTS | ||
| Acetic acid | ≤ 10% | In-house |
| Water | ≤ 10% | USP/Ph.Eur. |
| Specific optical rotation [α]20D (c = 0.1, 1% acetic acid) |
Report result (corrected for water and acetate) | In-house |
| Trifluoroacetic acid | ≤ 0.25% | In-house |
| Perchlorate | ≤ 0.1% | In-house |
| RESIDUAL SOLVENTS | ||
| Any individual residual solvent | ≤ 0.1% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | Report result (CFU/g) | In-house |
| Bacterial endotoxins |
Report result (IU/mg) |
USP/Ph.Eur. |
