Iron Sucrose Saccharated iron oxide Ferric hydroxide sucrose complex
Items | Standard |
---|---|
Appearance |
Brown to dark brown powder |
Identification A(Iron) |
Conform to USP Iron test |
Identification B(Sucrose) |
The retention time of the major peak in HPLC of the assay determination corresponds to that in the chromatogram of the standard determination under assay for sucrose. |
Limit of Iron(II) |
NMT 0.4% |
PH |
10.5~11.1 |
Content of Chloride |
NMT 0.075% |
Turbidity (PH) |
4.4~5.3 |
Specific gravity |
1.135~1.165(20℃) |
Osmolarity |
1150~1350mOsmol/L |
Alkalinity
|
0.5~0.8ml/ml |
Mw |
34000~60000 Da |
Mn |
NLT 24,000 Da |
Mw/Mn |
NMT 1.7 |
Loss on Drying |
NMT 5% |
Heavy Metal |
NMT 25 ppm |
Arsenic |
NMT 4 ppm |
Assay-Sucrose |
NLT 80% (on as is basis) |
Assay-Iron |
5.0%~6.0% (on as is basis) |
Items | Standard |
---|---|
Appearance |
Brown to dark brown powder |
Identification A(Iron) |
Conform to USP Iron test |
Identification B(Sucrose) |
The retention time of the major peak in HPLC of the assay determination corresponds to that in the chromatogram of the standard determination under assay for sucrose. |
Limit of Iron(II) |
NMT 0.4% |
PH |
10.5~11.1 |
Content of Chloride |
NMT 0.075% |
Turbidity (PH) |
4.4~5.3 |
Specific gravity |
1.135~1.165(20℃) |
Osmolarity |
1150~1350mOsmol/L |
Alkalinity
|
0.5~0.8ml/ml |
Mw |
34000~60000 Da |
Mn |
NLT 24,000 Da |
Mw/Mn |
NMT 1.7 |
Loss on Drying |
NMT 5% |
Heavy Metal |
NMT 25 ppm |
Arsenic |
NMT 4 ppm |
Assay-Sucrose |
NLT 80% (on as is basis) |
Assay-Iron |
5.0%~6.0% (on as is basis) |
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