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)
