hPTH (1-34) specifications
PDF Version [44 KB PDF]
| Molecular weight: | 4117.8 (free peptide) | |
|---|---|---|
| hPTH (1-34) 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 |
|
| Last update: | 30 AUG 2007 | |
| Available registration documents (CTD format): Contact PolyPeptide Group 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 1% acetic acid at a concentration of 1 mg/mL to give a clear, colorless solution
|
Ph.Eur. |
| IDENTIFICATION | ||
| Identification, MS |
Monoisotopic mass
4115.1 ± 1 |
In-house |
| Amino acid analysis |
Asx: 3.6 to 4.4
Ser: 2.55 to 3.45 Glx: 4.5 to 5.5 Gly: 0.9 to 1.1 Val: 2.55 to 3.45 Met: 1.8 to 2.2 Ile: 0.85 to 1.15 Leu: 4.5 to 5.5 Phe: 0.9 to 1.1 His: 2.7 to 3.3 Lys: 2.7 to 3.3 Trp: 0.4 to 1.15 Arg: 1.8 to 2.2 |
In-house |
| Identification, HPLC |
Co-elutes with reference standard
System I and XI |
In-house |
Other specifications of hPTH (1-34)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. |
