PharmaceuticalsMineral FortifiersSpeciality ChemicalsDextrose-Anhydrous Glucose BP

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Dextrose-Anhydrous Glucose BP

 Specifications: 

Test Specification……BP
Appearance It appears as a white or almost white, crystalline powder.
Identification

Test A

Test B

 

Test C

 

a)      Specific optical rotation: + 52.5 to + 53.3 (anhydrous substance)

b)      Specified test

c)       Test for Water- Not more than 1.0%

Solubility Freely soluble in water, very slightly soluble in ethanol (96%).
Clarity and Color of Solution The solution is clear and not more intensely colored than reference solution BY7
Conductivity Not more than 20 µS⋅cm-1
Related substances-

a)      Sum of impurities A and B

b)      Impurity C

c)       Impurity D

d)      Unspecified impurities

e)      Total

 

a)      Not more than 0.4%

b)      Not more than 0.2%

c)       Not more than 0.15%

d)      Not more than 0.10%

e)      Not more than 0.5 %

Dextrin Specified test
Acidity Specified test
Soluble starch, sulfite Not more than 15 ppm
Water by KF Not more than 1.0 %
Sulfate Not more than 0.024%
Chloride Not more than 0.018%
Arsenic Not more than 1.3%
Residue on Ignition Not more than 0.10 %
Heavy metals Not more than 4ppm
Bacterial Endotoxin Not more than 2.5EU/gm
Loss on drying Not more than 1.0%
Bioburden Testing Not less than 50 CFU/gm
Assay Not less than 97.5 % and not more than 102.0% (anhydrous substance)

It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.Shelf life, Storage and Packing

 

Other
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.

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