Product Name | Ceftiofur Hydrochloride, Ceftiofur HCL | ||
Items | Standard | Results | |
Appearance | White or off-white crystalline powder | Comply | |
Assay | 98.0~103.0% (% w/w by HPLC as C19H17N3O7S3.HCl on anhydrous basis) | 99.68% | |
Solubility | Soluble in N,N-Dimethylacetamide, slightly soluble in 5% aqueous sodium bicarbonate solution and in methanol | Comply | |
Identification | IR: IR spectrum of sample as KBr pellet is concordant with similar recorded spectrum of working standard | Comply | |
HPLC: The retention time of the major peak in the chromatogram of the sample preparation corresponds to that in the chromatogram of the standard preparation as obtained in the assay | Comply | ||
Related Substance | Single largest impurity | ≤1.0% | 0.48% |
Total impurities | ≤2.0% | 1.26% | |
Moisture | ≤4.0% | 3.22% | |
PH | 2.0~3.0 | 2.51 | |
Absorbance | ≤0.500A | 0.345A | |
Specific rotation | -115° ~ -125° | -122.52° | |
Residue on ignition | ≤0.5% | 0.05% | |
Particle size | 90%<10um | Comply | |
Sterility | Comply | Comply | |
Storage | Keep tightly closed. If long time no use, Please keep below 5 °C. | ||
Determination | Complies with enterprise standard |
Function:
1. protects epithelial cell membranes in the stomach and restores them to their normal metabolism;
2. acts as an antioxidant and protects the stomach from alcohol and smoking-induced damage;
3 has anti-inflammatory properties and moderates production of interleukin-8;
4. adheres to ulcerations, acts as a barrier between them and stomach acids and helps to heal them;
5. inhibits activity of Helicobacter pylori bacteria;
6. does not interfere with the production of prostaglandins essential to the mucosal lining of the stomach;
7.strengthens these mucosal linings and stimulates production of protective mucous.
Product Name | Ceftiofur Hydrochloride, Ceftiofur HCL | ||
Items | Standard | Results | |
Appearance | White or off-white crystalline powder | Comply | |
Assay | 98.0~103.0% (% w/w by HPLC as C19H17N3O7S3.HCl on anhydrous basis) | 99.68% | |
Solubility | Soluble in N,N-Dimethylacetamide, slightly soluble in 5% aqueous sodium bicarbonate solution and in methanol | Comply | |
Identification | IR: IR spectrum of sample as KBr pellet is concordant with similar recorded spectrum of working standard | Comply | |
HPLC: The retention time of the major peak in the chromatogram of the sample preparation corresponds to that in the chromatogram of the standard preparation as obtained in the assay | Comply | ||
Related Substance | Single largest impurity | ≤1.0% | 0.48% |
Total impurities | ≤2.0% | 1.26% | |
Moisture | ≤4.0% | 3.22% | |
PH | 2.0~3.0 | 2.51 | |
Absorbance | ≤0.500A | 0.345A | |
Specific rotation | -115° ~ -125° | -122.52° | |
Residue on ignition | ≤0.5% | 0.05% | |
Particle size | 90%<10um | Comply | |
Sterility | Comply | Comply | |
Storage | Keep tightly closed. If long time no use, Please keep below 5 °C. | ||
Determination | Complies with enterprise standard |
Function:
1. protects epithelial cell membranes in the stomach and restores them to their normal metabolism;
2. acts as an antioxidant and protects the stomach from alcohol and smoking-induced damage;
3 has anti-inflammatory properties and moderates production of interleukin-8;
4. adheres to ulcerations, acts as a barrier between them and stomach acids and helps to heal them;
5. inhibits activity of Helicobacter pylori bacteria;
6. does not interfere with the production of prostaglandins essential to the mucosal lining of the stomach;
7.strengthens these mucosal linings and stimulates production of protective mucous.