White or almost white crystalline or finely granulated powder
Appearance (USP)
A white crystalline or finely granulated powder
Solubility (EP, BP)
Freely soluble or soluble in water, very slightly soluble in 96% ethanol
Solubility: (USP)
Soluble in water, very slightly soluble in alcohol
Identification A : FTIR (USP, EP, BP)
Matches with the standard pattern
Identification B : TLC (EP, BP)
The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a)
Identification B : (USP)
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: (USP, EP, BP)
An orange or red precipitate is formed.
Appearance of solution : (USP)
The sample solution is not more intensely coloured than the control solution
Appearance of solution : (EP, BP)
20% solution at 50°C is not more intensely coloured than the reference solution B8
Acidity and alkalinity : (USP, EP, BP)
<= 1.5 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to pink.
Barium: (BP)
Any opalescence in the solution is not more intense than that in a mixture of 5 mL of solution S and 6 mL of distilled water R.
Barium: (USP)
Any opalescence in the Sample solution is not more intense than that in the Standard solution
Lead: (USP, BP)
<= 0.00005%
Water (K.F.) : (USP, EP, BP)
<= 1.00%
Sulphated ash : (EP, BP)
<= 0.10%
Residue on ignition : (USP)
<= 0.10%
Specific optical rotation : (USP)
+78.00° to +81.50° (c= 10% in water + 0.2 mL of ammonia solution, at 20°C)
Proteins: (EP, BP)
<= 0.1mg/mL
Microbial contamination, TAMC : (EP, BP)
<= 100.00 cfu/gm
Microbial contamination, TAMC: (USP)
<= 1000 cfu/gm
Microbial contamination, TYMC: (USP)
<= 100 cfu/gm
Pathogens (Salmonella)
Not detected
Pathogens (E. coli)
Not detected
Pathogens (S. aureus)
Not detected
Pathogens (P. aeruginosa)
Not detected
System suitability 1, related substances and assay, HPLC: Resolution (EP, BP)
min. 2.0 between the peak due to impurity C and galactose
System suitability 2, related substances and assay, HPLC : Resolution (USP)
>= 3.0 between the lactose and galacturonic acid peaks
System suitability 3, related substances and assay, HPLC : Resolution (USP)
>= 1.5 between the galacturonic acid and dextrose peaks
System suitability 4, related substances and assay, HPLC : Resolution (USP)
>= 2.00 between the dextrose and galactose peaks
System suitability 5, related substances and assay, HPLC : Resolution (USP)
>= 3.0 between the galactose and arabinose peaks
System suitability 6, related substances, HPLC : RSD (USP)
<= 1.00%
Related substances, HPLC : Sum of impurities A & B (EP, BP)
<= 1.0%
Related substances, HPLC : Unspecified impurities, for each impurity (EP, BP)
<= 0.3%
Related substances, HPLC : Total impurities (EP, BP)
<= 2.0%
Related substances, HPLC : Lactose and 1,6-galactosylgalactose (USP)
<= 0.60%
Related substances, HPLC : Galacturonic acid (USP)
<= 0.60%
Related substances, HPLC: Dextrose (USP)
<= 0.60%
Related substances, HPLC : Tagatose (USP)
<= 0.60%
Related substances, HPLC : Dulcitol (USP)
<= 0.60%
Related substances, HPLC : Arabinose (USP)
<= 0.60%
Related substances, HPLC : any unspecified impurity (USP)
<= 0.20%
Related substances, HPLC : total impurity (USP)
<= 1.00%
Assay (HPLC, anhydrous basis) : (EP, BP)
97.0 - 102.0%
Assay (HPLC, anhydrous basis) : (USP)
98.00 - 102.00
Storage and Shelf Life
Storage Conditions
Store below 30°C away from bright light.
Shelf life
48 months.
Use By
Use before expiry date given on the product label.