iron sucrose

TEST ITEM SPECIFICATION OBSERVATION Appearance Brown to dark brown powder Conforms Identification A (Iron) Conform to USP Iron test Conforms 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 Conforms Limit of Iron(II) NMT 0.4% 0.23% pH 10.5～11.1 10.90 Content of Chloride NMT 0.075% 0.058% Turbidity (pH) 4.4～5.3 4.86 Specefic gravity 1.135～1.165(20℃) 1.153 Osmolarity 1150～1350mOsmol/L 1220 mOsmol/L Alkalinity 0.5～0.8ml/ml 0.63 ml/ml Mw 34000～60000 Da 46000 Mn NLT 24,000 Da 32800 Mw/Mn NMT 1.7 1.40 Loss on Drying NMT 5% 2.0% Heavy Metal NMT 25 ppm Conforms Arsenic NMT 4 ppm Conforms Assay-Sucrose NLT 80% (on as is basis) 86.5% Assay-Iron 5.0%～6.0% (on as is basis) 5.56%