Grade Standard: | Medicine Grade |
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Type: | Chemical Reagent |
State: | Solid |
Volatile: | Not Volatile |
Standard: | Ep |
Shelf Life: | 24 Months |
Samples: |
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Items | Standard |
Appearance | White or almost white, crystalline powder. |
Solubility | Freely but lowly soluble in water, practically insoluble in ethanol (96 per cent). |
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 | NMT 0.1% |
Heavy metals | NMT 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 NMT 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 ro red color. |
Loss on drying | Dry a sample at 80°for 2 h. NMT 0.5% |
Water | 4.5%~5.5% |
Protein and light-absorbing impurities |
210-220 nm: NMT 0.25 270-300 nm: NMT 0.07 |
TAMC(cfu/g) | <100 |
Molds and Yeasts(cfu/g) | <50 |
Escherichia coli. (/10g) | absence |
Assaying | This product is 4-O-β-D- pyran galactosyl -D- glucose monohydrate.The content of C12 H22 O11 should be 98.0% ~ 102.0%. |
Acidity | Take 1.0g of this product, and the pH value should be 4.0-7.0 |
Boundary particle size Over 60 mesh > 80% , Over 120 mesh < 40%.(Single sieve method) |
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