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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: 57773-63-4
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/TP/01-1 |
|
Solubility (EP.curr.ed) |
Very soluble in water, 1% acetic acid . |
Very soluble in water, 1% acetic acid |
PT/QC/TP/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/TP/01-3 |
|
Amino acid analysis (EP.curr.ed) |
Amino acid limits Asp (0.90-1.10) Glu (0.90-1.10) Pro (0.90-1.10) Gly (3.60-4.40) Phe (0.90-1.10) Lys (0.90-1.10) Tyr (0.90-1.10) Half-Cys (1.0-2.0) No more than the traces of the other amino acids are present. |
1.01 0.99 1.00 1.01 1.02 0.97 0.96 1.50 Complies |
PT/QC/TP/01-4 |
|
pH (EP.curr.ed) |
5.0-7.0 | 6.35 | PT/QC/TP/01-5 |
|
Related Substances (EP.curr.ed) |
unspecified impurity for each impurity: NMT 0.5% Total impurity: NMT 2% |
0.23%(single largest impurity) 0.23% |
PT/QC/TP/01-6 |
|
Acetic acid (EP.curr.ed) |
6%-10% | 7.2% | PT/QC/TP/01-7 |
|
water (EP.curr.ed) |
NMT 8% | 4.5% | PT/QC/TP/01-8 |
|
Bacterial Endotoxins (EP.curr.ed) |
Less than 300IU/mg | complies | PT/QC/TP/01-9 |
|
Assay (EP.curr.ed) |
95%-103% | 98.60% | PT/QC/TP/01-10 |
| Specific Optical Rotation | -93 to -103 | -95.6 | PT/QC/TP/01-12 |
|
Residual solvent Methanol Acetonitrile Triethylamine |
NMT 3000ppm NMT 410 ppm NMT 320 ppm |
Less than LOD 32ppm Less than LOD 90ppm Less than LOD 14ppm |
PT/QC/TP/01-13 |
