Lactose Anhydrous
Brief Introduction:
Anhydrous lactose is one of the types of sugar, mainly used as a pharmaceutical excipient.
Specifications of our Lactose Anhydrous USP40:
| Test Items | Specifications |
| Appearance | White or almost white crystalline powder |
| Solubility | Freely but lowly soluble in water, practically insoluble in ethanol(96%) |
| 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 5 μg per g |
| Clarity and Colour of Solution | The solution(1g in 10 ml of boiling water) is clear and nearly colourless. |
| Determine the absorbance of this solution at a wavelength of 400 nm. The absorbance divided by the path length, in cm, which is not more than 0.04. | |
| Optical Rotation | +54.4°~ +55.9°, calculated on the anhydrous basis, determined at 20℃ |
| Acidity or alkalinity | Adding 0.3 ml of phenolphthalein TS: the solution is colourless, and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a pink to red colour. |
| Loss on Drying | Not more than 0.5% after drying a sample at 80℃ for 2 hours |
| Water | Less than 1.0% |
| Protein and light-absorbing impurities | 210 nm ~ 220 nm: Not more than 0.25 |
| 270 nm ~ 300 nm: Not more than 0.07 | |
| Total Plate Count | Less than 100 CFU/g |
| Yeasts & Moulds | Less than 50 CFU/g |
| Escherichia coli | Negative/10g |
| Assay | The chemical name of this product is O-β-D-galactopyranosyl-(1→4))-α-D-glucopyranos anhydrate. The content of C12H22O11 should be between 98.0% and 102.0%. |
| Acidity | Taking 1.0 g of this product, and the pH value should be between 4.0 and 7.0. |
Applications:
Lactose is widely used as a filler or diluent for tablets and capsules, and sometimes in freeze-dried products and baby food formulas. Lactose is also used as a diluent in powder inhalers.
Other applications include: as a carrier/diluent in inhalants and lyophilized formulations. Lactose is added to the lyophilization solution to increase bulk and aid in the formation of lyophilized lumps. Lactose is also mixed with sucrose in a ratio of approximately 1:3 and used as a coating solution.
Generally speaking, which grade of lactose to choose depends on the pharmaceutical dosage form being developed. Lactose for direct compression is often used for tablets with a small drug content, which can save the granulation process.
Packaging:
25 kilograms per kraft paper bag or according to the specific requirements from customers.
Storage Conditions:
Preserved in unopened original containers in a cool dry place before using; kept away from direct sunlight, heat and moisture.
Shelf Life:
24 months if stored under above conditions.
