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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: 3KG
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: 50-56-6
Appearance: White hygroscopic powder
(EP. Curr. Ed)
Purity (by HPLC): More than 98.50%
Single impurity: Less than 0.50%
| Test | Specification | Result |
Test method Reference No. |
|
Appearance (EP.curr.ed) |
White or almost white , hygroscopic powder | White hygroscopic powder | PT/QC/OT/01-1 |
|
Solubility (EP.curr.ed) |
Very soluble in water, it dissolves in dilute solutions of acetic acid and ethanol(1:20). |
Very soluble in water, it dissolves in dilute solutions of acetic acid and ethanol (1:20). | PT/QC/OT/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/OT/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 (0.90-1.10) Leu (0.90-1.10) Ile (0.90-1.10) Tyr (0.7-1.05) Half-Cys (1.40-2.10) 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/OT/01-4 |
|
pH (EP.curr.ed) |
3.0-6.0 (200mg OT in 10ml Of CO2 free water) |
4.35 | PT/QC/OT/01-5 |
|
OXYTOCIN EP Powder(Synthetic) |
Cas No.: 50-56-6 |
| Test | Specification | Result |
Test method Reference No. |
|
Related Substances (EP.curr.ed) |
Specified impurities Impurity A : NMT 1.0% Impurity B : NMT 1.5% Impurity C : NMT1.0% Any unspecified impurity: NMT 5% Total impurity: NMT 5% |
0.20% 0.25% 0.45% |
PT/QC/OT/01-6 |
|
Acetic acid (EP.curr.ed) |
6%-10% | 7.2% | PT/QC/OT/01-7 |
|
water (EP.curr.ed) |
NMT 5% | 4.5% | PT/QC/OT/01-8 |
|
Bacterial Endotoxins (EP.curr.ed) |
Less than 300IU/mg | complies | PT/QC/OT/01-9 |
|
Assay (EP.curr.ed) |
93%-102% | 95.60% | PT/QC/OT/01-10 |
| Biological activity | Not less than 480IU/mg | 574IU/mg | PT/QC/OT/01-11 |
| Specific Optical Rotation | -19.5 to -23.5 | -21.5 | PT/QC/OT/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/OT/01-13 |
