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| Molecular weight: | 4567.6 (free peptide) | |
|---|---|---|
| Sequence: |
H-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-Lys- Pro-Val-Gly-Lys-Lys-Arg-Arg-Pro-Val-Lys-Val- Tyr-Pro-Asn-Gly-Ala-Glu-Asp-Glu-Leu-Ala-Glu- Ala-Phe-Pro-Leu-Glu-Phe-OH |
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| Last update: | 30 AUG 2007 | |
|
Available registration documents (CTD format): None, the substance is sold based on its CoA 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 or almost white amorphous powder of low density |
Visual inspection |
| IDENTIFICATION | ||
| Amino acid analysis |
Asp: 1.8 to 2.2 |
In-house |
| Identification, HPLC |
Conforms to reference standard |
In-house |
| PURITY | ||
| Peptide purity, HPLC: | ≥ 95% | In-house |
| ASSAY | ||
| Potency, HPLC | ≥ 70 IU/mg | In-house |
| OTHER TESTS | ||
| Acetic acid | < 15% | In-house |
| Water | ≤ 7% | USP/Ph.Eur. |
| Trifluoroacetic acid | ≤ 0.3% | In-house |
| RESIDUAL SOLVENTS | ||
| N,N-Dimethyl- formamide |
≤ 880 ppm | In-house |
| Methanol | ≤ 0.3% | In-house |
| Diethyl ether | ≤ 0.5% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | < 102 CFU/g | Ph.Eur. |
| Bacterial endotoxins |
≤ 318 IU/mg |
USP/Ph.Eur. |
