ZIBO ZHANGDIAN HAIDING CHEMICAL PLANT

Liangxiang Industry park,Zhangdian,Zibo,Shandong,China

Tel:0086-533-2091136 FAX:0086-533-2091136

CERTIFICATE OF ANALYSIS
Product:Iron sucrose CAS NO.:8047-67-4
Batch No.:1706030 Date of Report.17/07/04
Date of Mfg.:17/07/02 Quantity: 200kg
Expiry date19/07/02

TEST ITEM SPECIFICATION OBSERVATION

Appearance Brown to dark brown powder Conforms
Identification A (Iron) Conform to USP Iron test Conforms
The retention time of the major peak in HPLC of the
assay determination corresponds to that in the
Identification B (Sucrose) Conforms
chromatogram of the standard determination under
assay for sucrose
Limit of Iron(II) NMT 0.4% 0.24%
pH 10.511.1 10.80
Content of Chloride NMT 0.075% 0.048%
Turbidity (pH) 4.45.3 4.9
Specefic gravity 1.1351.165(20) 1.147
Osmolarity 11501350mOsmol/L 1220 mOsmol/L
Alkalinity 0.50.8ml/ml 0.69 ml/ml
Low molecular weight compounds
Non-detective complies
of iron()and Iron ()
Mw 3400060000 Da 44900
Mn NLT 24,000 Da 32400
Mw/Mn NMT 1.7 1.40
Loss on Drying NMT 5% 1.90%
Heavy Metal NMT 25 ppm Conforms
Arsenic NMT 4 ppm Conforms
Assay-Sucrose NLT 80% (on as is basis) 86.8%
Assay-Iron 5.0%6.0% (on as is basis) 5.53%
Bacterial endtoxin test Not more than 3.7EU/mg of iron complies
Total mould&yeast count Max 10cfu/g complies
Total aerobic microbial count Max 100cfu/g complies
E.coli Non-detective complies

REMARKS:THE PRODUCT COMPLIES AS PER THE LAID DOWN SPECIFICATION.

QA/QC MANAGER CHECKED BY ANALYSED BY