 |
| Menge: | |
|---|---|
DY2156
1405-10-3
215-773-1
H2O4S.xW99
Neomycin, sulfate (salt)
| Index Name | Specifications: EP6.0 |
| Appearance | White to yellowish-white powder |
| Odor | Odorless, or almost |
| Identification | A; B; C The positive reaction |
| PH | 5.0 to 7.5 |
| Specific optical rotation | +53.5 to +59.0 degree |
| Neomycin A | Method liquid chromatography: 2%max |
| Neomycin C | 3% to 15% |
| Any other impurity | Not more than the area of the principal peak in the chromatogram obtained with RS (B) (5%) |
| Total of other impurity | Not more than 3 times the area of the principal peak in the chromatogram obtained with RS (B) (15%) |
| Disregard limit | Area of the principal peak in the chromatogram obtained with RS (C) (1%) |
| Sulphate | 27.0% to 31.0% |
| Loss on drying | 8.0%max |
| Sulphated ash | 1.0%max |
| Microcount-Yeasts and molds | NMT 10col/g |
| Microcount-Escherichia coli | Absent/g |
| Microcount-staphy lococcus aureus | Absent/g |
| Microcount-Pseudo monas | Absent/g |
| Assay | 680I.U./mg min |
| Index Name | Specifications: EP6.0 |
| Appearance | White to yellowish-white powder |
| Odor | Odorless, or almost |
| Identification | A; B; C The positive reaction |
| PH | 5.0 to 7.5 |
| Specific optical rotation | +53.5 to +59.0 degree |
| Neomycin A | Method liquid chromatography: 2%max |
| Neomycin C | 3% to 15% |
| Any other impurity | Not more than the area of the principal peak in the chromatogram obtained with RS (B) (5%) |
| Total of other impurity | Not more than 3 times the area of the principal peak in the chromatogram obtained with RS (B) (15%) |
| Disregard limit | Area of the principal peak in the chromatogram obtained with RS (C) (1%) |
| Sulphate | 27.0% to 31.0% |
| Loss on drying | 8.0%max |
| Sulphated ash | 1.0%max |
| Microcount-Yeasts and molds | NMT 10col/g |
| Microcount-Escherichia coli | Absent/g |
| Microcount-staphy lococcus aureus | Absent/g |
| Microcount-Pseudo monas | Absent/g |
| Assay | 680I.U./mg min |