| Customization: | Available |
|---|---|
| CAS No.: | 63-42-3 |
| Formula: | C12h22o11 |
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Description: Anhydrous Lactose is a white, crystalline powder derived from milk. It is used extensively in the pharmaceutical industry as an excipient due to its excellent binding properties and stability. It is also used in food products as a sweetener and filler.
Chemical Formula: C12h22o11
CAS Number: 63-42-3
Molecular Weight: 342.30 g/mol
| 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. | ||||
TIANJIN WANHUI BIOTECHNOLOGY CO .,LTD is located in Tianjin China. We mainly Medical Intermediate,
Cosmetics raw materials, Food Additive. Products are exported to North America, Europe, Australia, Middle
East and other regions. At the same time, we can also provide customers with product customization
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Our factory covers an area of approximately 3,800 square meters. The first-class R&D team,
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Our factory has been developing vigorously, and the production capacity has been rising constantly,
which can meet the demands of customers more and faster. Even for large orders, we can complete
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Choosing us, you will have a reliable partner, high-quality products, fast and safe transportation,
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