| CAS No.: | 63-42-3 |
|---|---|
| Type: | Pharmaceutical Excipients |
| Appearance: | Powder |
| Quality: | Technical |
| Colour: | White |
| MOQ: | 1 Kilograms |
| Samples: |
|---|
| Customization: |
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Lactose is widely used as excipients in many countries.
General Information:
Type: Food Additives/API's
Origin: China
CAS No.: 63-42-3
AUCO No.: 919
Packing: 25kg bag
Specification:
| 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 hydro 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 |
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