| ATTRIBUTE |
SPECIFICATION |
RESULTS |
| 1. Appearance |
White powder |
White Powder |
2. Purity (%): HPLC; TEAP
Purity (%): HPLC; TFA
Purity (%): HPLC; Isocratic |
> 98 %
> 98 %
> 98 % |
100 %
100 %
99.6 % |
3. AAA Composition
(Beckman Model 6300) |
+ 10 % of theoretical calc
except Ile, Thr, Ser & Val. |
Acceptable
|
4. Water content
(Karl Fischer)
|
< 10 % |
6.2 % |
|
5. Solubility
|
1 mg/mL (1.0 % Acetic Acid)
yields a clear, colorless solution |
Acceptable
Conforms |
6. Counter ion (Acetate)
(Ion Chromatography)
|
To be reported |
3.67 % |
7. Peptide Content (PC)
(Calc from % N, or by AAA)
|
To be reported |
91.1 % ; (calc from 16.1 %
N results) |
8. Fluoride Content
(Specific Ion Electrode)
|
< 0.1 % |
122 ppm ( < 0.1 %) |
9. Mass Balance
(PC+Water+Acetate)
|
95 - 105 % (items 4+6+7) |
101 % |
10. Molecular Weight
(MS-Fab)
|
4757.5 + 1 |
4758.3 |
11. Residual Solvents
(TD-GC-MS)
|
< 0.25 % Total Residuals
( < 0.1 % of any individual solvent) |
< 0.1 % (Total) |
|
12. Micro Bioburden
|
To be reported |
0.4 CFU/mg |
|
13. Endotoxin (USP LAL)
|
To be reported |
< 0.06 EU/mL (1 mg/mL) |
