| Customization: | Available |
|---|---|
| CAS No.: | 63-42-3 |
| Formula: | C12h22o11 |
|
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| Test items | Criterion | Results | |||
| Identification A | The infrared absorption spectrum of the sample is concordant with that of the standard. | Complies | |||
| Identification B | The principal spot obtained from the Test solution corresponds in appearance and RF value to that obtained from Standard solution A. | Complies | |||
| 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% | 0.03% | |||
| Heavy metals | Not more than 5µg per g. | Complies | |||
| Clarity and color of solution | The solution (1g in 10ml of boiling water) is clear 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. | Complies 0.01 | |||
| Optical rotation | +54.4°~+55.9°, calculate on the anhydrous basis, determined at 20° | +55.2° | |||
| 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. | Complies | |||
| Loss on drying | Dry a sample at 80° for 2 h. not more than 0.5% | 0.08% | |||
| Water | 4.5%~5.5% | 5.2% | |||
| Protein and light-absorbing impurities | 210-220 nm: Not more than 0.25 270-300 nm: Not more than 0.07 | 0.03 0.01 | |||
| TAMC (cfu/g) | <100 | <10 | |||
| Molds and Yeasts (cfu/g) | <50 | <10 | |||
| Escherichia coli (/10g) | absence | Not detected | |||
| Assaying | This product is 4-O-β-D- pyran galactosyl -D-glucose monohydrate. The content of C12H22O11 should be 98.0%~102.0%. | 99.6% | |||
| Acidity | Take 1.0g of this product, and the pH value should be 4.0~7.0. | 4.7 | |||
| Conclusion : | The Quality of lactose product has the achieved standard of USP30 after examination standard examination, and consequently meet the provision. | ||||
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