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D-(+)-Galactose anhydrous, Meets USP 41-NF 36 testing specifications
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| 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 |