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25 Kilogram |
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Sultamicillic tosylate Sultamicillin Tosilate Sultamicillin
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Product name |
Sultamicillin tosilate |
CAS No. |
83105-70-8 |
Molecular Formula |
C7H8O3S*C25H30N4O9S2 |
Molecular Weight |
766.871 |
Molecular Structure |
|
Quality Standard |
98% up by HPLC |
Appearance |
White or almost white crystalline powder |
|
ANALYSIS |
SPECIFICATION |
RESULTS |
Appearance |
White or almost white crystalline powder |
Complies |
Identification |
The infrared absorption spectrum: accordance with the reference standard. |
Complies |
Specific rotation (anhydrous substance) |
+178。 to +195。 |
+192.8。 |
Water |
4.0% to 6.0% |
5.3% |
Heavy metals |
≤0.002% |
< 0.002% |
Sulphated Ash |
≤0.2% |
0.05% |
Related substance |
Impurity A(Sulbactam) ≤ 0.50% |
0.02% |
Impurity B(Ampicillin) ≤ 2.0% |
0.46% |
|
Impurity C ≤ 0.5% |
0.10% |
|
Impurity D ≤ 0.5% |
0.08% |
|
Impurity E ≤ 0.5% |
0.19% |
|
Impurity F ≤ 0.5% |
ND |
|
Impurity G ≤ 0.5% |
0.16% |
|
Any other impurity ≤ 0.50% |
0.03% |
|
Total impurities ≤ 4.0% |
ND |
|
Assay (anhydrous substance) |
95% - 102% |
99.9% |
Ethyl acetate |
≤2000ppm |
415ppm |
Conclusion |
The product complies with specification. |
|
What is Sultamicillin tosilate
Sultamicillin tosilate is a diester formed by connecting equimolar amounts of ampicillin and sulbactam. After oral administration, it is hydrolyzed in the intestinal wall by intestinal lactonase into sulbactam and ampicillin to exert its effects. Sultacillin is most commonly used in the treatment of various diseases of respiratory tract infection, especially in the field of pediatrics, it has achieved good results in the treatment of suppurative otitis, pharyngitis, impetigo, bronchitis and scarlet fever in children.
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