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D-(+)-Galactose anhydrous, Meets USP 41-NF 36 testing specifications
More Information
Product Name |
D-(+)-Galactose anhydrous, Meets USP 41-NF 36 testing specifications |
SKU |
TC127U |
CAS No |
59-23-4 |
Molecular formula |
C6H12O6 |
Molecular Weight |
180.16 |
Storage |
Below 30°C |
Shelf Life |
4 Years |
Customized Product Available |
No |
Appearance |
A white crystalline or finely granulated powder |
Solubility |
Soluble in water, very slightly soluble in alcohol |
Identification A : FTIR |
Matches with the standard pattern |
Identification B |
The retention time of the major peak of the Sample solution corresponds to the galactose peak of the Standard solution, as obtained in the Assay |
Identification C |
An orange or red precipitate is formed. |
Appearance of solution |
20% solution in water with heating at 50°C is not more intensely coloured than the control solution |
Acidity |
<= 1.5 mL of 0.01N sodium hydroxide is required |
Barium |
Any opalescence in the Sample solution is not more intense than that in the Standard solution |
Lead |
<= 0.00005% |
Water (K.F.) |
<= 1.00% |
Residue on ignition |
<= 0.10% |
Specific optical rotation |
+78.00° to +81.50° (c= 10% in water + 0.2 mL of ammonia solution, at 20°C) |
Microbial contamination, TAMC |
<= 1000 cfu/gm |
Microbial contamination, TYMC |
<= 100 cfu/gm |
Pathogens (Salmonella) |
Not detected |
Pathogens (E. coli) |
Not detected |
Pathogens (S. aureus) |
Not detected |
System suitability 1, related substances and assay, HPLC : Resolution |
>= 3.0 between the lactose and galacturonic acid peaks |
System suitability 2, related substances and assay, HPLC : Resolution |
>= 1.5 between the galacturonic acid and dextrose peaks |
System suitability 3, related substances and assay, HPLC : Resolution |
>= 2.00 between the dextrose and galactose peaks |
System suitability 4, related substances and assay, HPLC : Resolution |
>= 3.0 between the galactose and arabinose peaks |
System suitability 5, Assay, HPLC : RSD |
<= 1.00% |
Related substances, HPLC : Lactose and 1,6- galactosylgalactose |
<= 0.60% |
Related substances, HPLC : Galacturonic acid |
<= 0.60% |
Related substances, HPLC : Dextrose |
<= 0.60% |
Related substances, HPLC : Tagatose |
<= 0.60% |
Related substances, HPLC : Dulcitol |
<= 0.60% |
Related substances, HPLC : Arabinose |
<= 0.60% |
Related substances, HPLC : any unspecified impurity |
<= 0.20% |
Related substances, HPLC : total impurity |
<= 1.00% |
Assay (HPLC, anhydrous basis) |
98.00 -102.00 |