Items |
Standard |
Identification A |
The infrared absorption spectrum of the sample is concordant with that of the standard. |
Identification B |
The principal spot obtained from the Test solution corresponds in appearance and RF value to that obtained from Standard solution A. |
The test is not valid unless the chromatogram obtained with Standard solution B shows four clearly discernible spots, disregarding any spots at the origin. |
Residue on ignition |
Not more than 0.1% |
Heavy metals |
Not more than 5µg per g. |
Clarity and color of solution |
The solution(1g in 10ml of boiling water) isclear and nearly colorless.Determine the absorbance of this solution at a wavelength of 400 nm.The absorbance divided by the path length,in cm,is not more than 0.04. |
Optical rotation |
+54.4°~+55.9°, calculate on the anhydrous basis,determined at 20° |
Acidity or alkalinity |
Add 0.3ml of phenolphthalein TS: the solution is colorless, and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a pink to red color. |
Loss on drying |
Dry a sample at 80° for 2 h. not more than 0.5% |
Water |
4.5%~5.5% |
Protein and light-absorbing impurities |
210-220 nm:Not more than 0.25 270-300 nm:Not more than 0.07 |
TAMC(cfu/g) |
<100 |
Molds and Yeasts(cfu/g) |
<50 |
Escherichia coli (/10g) |
absence |