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: 53714-56-0
Purity: ≥ 95.0%
Appearance: White powder
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Test |
Specification |
Result |
Test method Reference No. |
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Appearance (EP.curr.ed) |
Hygroscopic, White or off-white powder |
Hygroscopic, White or off-white powder |
PT/QC/LP/01-1 |
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Solubility
|
Very soluble in water, 1% acetic acid . |
Very soluble in water, 1% acetic acid
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PT/QC/LP/01-2 |
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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/LP/01-3 |
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IR spectrophotometry (EP.curr.ed) |
The spectrum obtained is similat to the reference spectrum. |
Complies |
PT/QC/LP/01-4 |
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Amino acid analysis (EP.curr.ed) |
Amino acid limits
No more than the traces of the other amino acids are present. |
1.02 1.01 1.96 1.03 0.95 1.05 present
Complies
|
PT/QC/LP/01-5 |
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Sulphated Ash (EP.curr.ed) |
NMT 0.3% |
0.16% |
PT/QC/LP/01-6 |
|
Test |
Specification |
Result |
Test method Reference No. |
|
Related Substances (EP.curr.ed) |
Impurity A: NMT 0.5% Impurity B: NMT 0.5% Impurity C: NMT 0.5% Impurity D: NMT 1.0%
Unspecified impurity for each impurity: NMT 0.5% Total impurity: NMT 2.5% |
None none 0.33% none
0.25%(single largest impurity) 0.58% |
PT/QC/LP/01-7 |
|
Acetic acid (EP.curr.ed) |
4.9%-9% |
7.0% |
PT/QC/LP/01-8 |
|
water (EP.curr.ed) |
NMT 5% |
3.5% |
PT/QC/LP/01-9 |
|
Bacterial Endotoxins (EP.curr.ed) |
Less than 4IU/mg |
complies |
PT/QC/LP/01-10 |
|
Assay (EP.curr.ed) |
97%-103%(anhydrous and acetic acid free substance) |
98.60% |
PT/QC/LP/01-11 |
|
Specific Optical Rotation(EP.curr.ed) |
-38 to -42(anhydrous and acetic acid free substance) |
-40.02 |
PT/QC/LP/01-12 |
|
Residual solvent Ethenol Methanol Acetonitrile Triethylamine |
NMT 5000ppm NMT 3000ppm NMT 410 ppm NMT 320 ppm |
Less than LOD 132ppm Less than LOD 32ppm Less than LOD 20ppm Less than LOD 14ppm |
PT/QC/LP/01-13 |
