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 |
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