瑞康國際開發有限公司 Reacom International Co.,Ltd

葡萄糖注射級

Dextrose Monohydrate Pharma_Injection Grade 一水葡萄糖(藥品_注射級)


■ High Quality Products:高品質產品
GMP Certificate TDMF:DMF(64)2467
ISO 9001:2008 Quality Management System
ISO 22000 Food Safety Management
KOSHER Certification
 
■ Product characteristics:化學特性
Character:White Crystalline or Crystal Powder,
Odour Free, Sweet
Chemical formula:C6H12O6 . H2O
Molar mass:198.160
Standard:Compliance with CP2015,USP39,BP2017









Packing (包裝)


Application(應用)




25kg paper plastic bags; 25kg plastic woven bag; 1000kg big bags


Injection Grade for pharmaceutical industry. For Haemodialysis raw material.










Transport regulations(運送)


Storage and handling(儲存)




Non dangerous good in the sense of transport regulations.


Storage cool and dry condition Non expose under the sunshine. Please see MSDS






 
Specification of Dextrose Monohydrate TDMF(64)2467一水葡萄糖規格(藥品_注射級)




Items


Specification


 Results




1.


Description


White Crystal, Odourless


Conforms 




2.


Identification


A, B, C


Conforms 




3.


Assay


≧99.5%


> 99.5% 




4.


Solubility


Freely soluble in water; Sparingly soluble in alcohol


Conforms




5.


Specific Optical Rotation


+52.5 ° ~ +53.3 °


+53.0 °




6.


Acidity or Alkalinity


6.0g, 0.1M NaOH  0.15ml


0.12ml




7.


Appearance of Solution


Clear, Odourless


Conforms




8.


Foreign Sugars, Soluble Starch, Dextrins


Conforms


Conforms




9.


Chlorides


≦125ppm


10ppm




10.


Water


7.0% ~9.5%


8.0%




11.


Sulphites(SO2)


≦15ppm


Conforms




12.


Sulphated Ash


≦0.1%


0.03%




13.


Calcium


≦200ppm


< 150ppm




14.


Barium


Conforms


Conforms




15.


Sulphates


≦200ppm


Conforms




16.


Lead in Sugars


≦0.5ppm


< 0,5ppm




17.


Arsenic


≦1.0ppm


< 1.0ppm




18.


Total Bacteria Count


≦1000pcs/g


< 10pcs/g




19.


Molds and Yeasts


≦100pcs/g


< 10pcs/g  




20.


Escherichia Coli


Negative


Negative




21.


Pyrogens


≦0.25Eu/ml


< 0.06Eu/ml




 

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