Products – Anmol Chemicals Private Limited

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
We Manufacture Bulk Dugs/API, Excipients, pharmaceuticals (IP/BP/USP/NF/PH. EUR./JP), Speciality Chemicals (Pure/AR/ACS), mineral fortifiers (FCC). our manufacturing facility is GLP, GMP (FDA) approved, ISO 9001, ISO 14001, ISO 22000, FSSC 22000, FSSAI, kosher, halal, COPP and WHO-GMP certified.

Good Manufacturing Practice Certified by World Health Organization (WHO-GMP)
Written Confirmation Certification (WC)
Good Manufacturing Practice (EXCiPACT cGMP)
Good Manufacturing Practice (cGMP)
Good Laboratory Practice (GLP)