Language
Factory Location: Hangzhou,Zhejiang,China
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Monthly Production Capacity: 2KG
Contract Manufacturing: CRO,CMO
Packaging Information: as per customer requests
Delivery Lead Time: 15 working days after getting confirmation of orde
Sample Provided: yes
Payment Terms: L/C T/T
Cas: 83150-76-9
Purity: ≥ 95.0%
Appearance: White powder
Single Impurity(HPLC) 1.0%max
| Test | Specification | Result |
Test method Reference No. |
|
Appearance (EP.curr.ed) |
White or off-white powder | White or off-white powder | PT/QC/OCTTP/01-1 |
|
Solubility (EP.curr.ed) |
Very soluble in water, 1% acetic acid . |
Very soluble in water, 1% acetic acid |
PT/QC/OCT/01-2 |
|
HPLC (EP.curr.ed) |
The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution. | Complies | PT/QC/ OCT /01-3 |
|
Amino acid analysis (EP.curr.ed) |
Amino acid limits Trp (0.90-1.10) Phe (1.80-2.20) Lys (0.90-1.10) Thr (1.80-2.20) Cys (1.70-2.30) No more than the traces of the other amino acids are present. |
1.01 1.95 0.97 1.96 1.85 Complies |
PT/QC/ OCT /01-4 |
|
pH (EP.curr.ed) |
5.0-7.0 | 6.12 | PT/QC/OCT/01-5 |
| Test | Specification | Result |
Test method Reference No. |
|
Related Substances (EP.curr.ed) |
unspecified impurity for each impurity: NMT 1.0% Total impurity: NMT 2% |
0.22%(single largest impurity) 0.23% |
PT/QC/OCT/01-6 |
|
Acetic acid (EP.curr.ed) |
5%-12% | 7.6% | PT/QC/OCT/01-7 |
|
water (EP.curr.ed) |
NMT 5% | 4.05% | PT/QC/OCT/01-8 |
|
Bacterial Endotoxins (EP.curr.ed) |
Less than 5EU/mg | complies | PT/QC/OCT/01-9 |
|
Assay (EP.curr.ed) |
95%-103% | 98.60% | PT/QC/OCT/01-10 |
| Specific Optical Rotation | -66 to -76(C=0.5, 1% acetic acid) | -72.5 | PT/QC/OCT/01-12 |
|
Residual solvent Methanol Acetonitrile Triethylamine |
NMT 3000ppm NMT 410 ppm NMT 320 ppm |
Less than LOD 32ppm Less than LOD 90ppm 210ppm |
PT/QC/OCT/01-13 |
