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| Molecular weight: | 1638.1 (free peptide) | |
|---|---|---|
| Sequence: |
H-Ala-Gly- _____________________________________ | | Cys-Lys-Asn-Phe-Phe-Trp-Lys-Thr-Phe-Thr-Ser-Cys-OH |
|
| Last update: | 30 AUG 2007 | |
|
Available registration documents (CTD format): EU DMF 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 amorphous powder |
Visual inspection |
| Solubility | Soluble in water at a concentration of 6 mg/mL to give a clear colorless solution |
Ph.Eur. |
| IDENTIFICATION | ||
| Identification, MS |
Monoisotopic mass |
Ph.Eur. |
| Amino acid analysis |
Asx: 0.90 to 1.10 |
Ph.Eur. |
| Identification, TLC |
The Rf value of the sample corresponds to the reference standard |
Ph.Eur. |
| Identification, HPLC |
Co-elutes with reference standard |
In-house |
| PURITY | ||
| Peptide purity, HPLC: | ≥ 98% | In-house |
| Related substances, HPLC: | In-house | |
| Total amount | ≤ 2% | |
| Any individual impurity | ≤ 1% |
| ASSAY | ||
|---|---|---|
| Mass balance | 95.0 to 103.0% | Calculation |
| OTHER TESTS | ||
| Acetic acid | 3.0 to 10.0% | In-house |
| Water | ≤ 8% | USP/Ph.Eur. |
| Specific optical rotation [α]20D (c = 0.2, 1% acetic acid) |
-37 to -47 (with reference to the anhydrous and acetic acid-free substance) |
Ph.Eur. |
| Specific optical rotation [α]20D (c = 0.2, 1% acetic acid) |
-37 to -47 (with reference to the anhydrous and acetic acid-free substance) |
Ph.Eur. |
| UV absorbance (280 nm, 5 mg/100 mL, 0.9% NaCl) |
≤ 0.20 (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 | Report value (CFU/g) | In-house |
| Bacterial endotoxins |
< 10 IU/mg |
USP/Ph.Eur. |
