Lactose anhydrous
Lactose anhydrous is a crystalline form of lactose consisting of two monosaccharide molecules. Its CAS NO. is 63-42-3. Anhydrous lactose can be used as a pharmaceutical excipient. The purity of anhydrous lactose can be improved by recrystallization.
Applications:
Pharmaceutical grade: In pharmaceuticals, lactose anhydrous is often used as an excipient in tablets, capsules, etc. It has good fluidity and compressibility which can improve the stability and taste of preparations.
Food grade: In the food field, lactose anhydrous is often used as a raw material in baking, sugar making and other processes. It can increase the sweetness and taste of food.
Other industry: In the field of cosmetics, lactose anhydrous is used in the formulation of facial creams, lotions and other products to have moisturizing and softening functions.
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. | |
| Identification C | A red color develops. |
| Specific optical rotation | +54.4°~+55.9°, calculate on the anhydrous basis |
| 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 red color. |
| Water | Not more than 1.0% |
| Residue on ignition | Not more than 0.1% |
| Heavy metals | The limit is 5µg per g. |
| Protein and light-absorbing impurities | The absorbance divided by the path length in centimeters is not more than 0.25 in the range of 210 to 220nm and is not more than 0.07 in the range of 270 to 300nm. |
| TPC | <100cfu/g |
| Yeast & Mould | <50cfu/g |
| Escherichia coli (/10g) | absence |
| Conclusion : | The Quality of lactose product has the achieved scandard of USP40 after examination standard examination, and consequently meet the provision. |
Lactose anhydrous
Lactose anhydrous is a crystalline form of lactose consisting of two monosaccharide molecules. Its CAS NO. is 63-42-3. Anhydrous lactose can be used as a pharmaceutical excipient. The purity of anhydrous lactose can be improved by recrystallization.
Applications:
Pharmaceutical grade: In pharmaceuticals, lactose anhydrous is often used as an excipient in tablets, capsules, etc. It has good fluidity and compressibility which can improve the stability and taste of preparations.
Food grade: In the food field, lactose anhydrous is often used as a raw material in baking, sugar making and other processes. It can increase the sweetness and taste of food.
Other industry: In the field of cosmetics, lactose anhydrous is used in the formulation of facial creams, lotions and other products to have moisturizing and softening functions.
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. | |
| Identification C | A red color develops. |
| Specific optical rotation | +54.4°~+55.9°, calculate on the anhydrous basis |
| 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 red color. |
| Water | Not more than 1.0% |
| Residue on ignition | Not more than 0.1% |
| Heavy metals | The limit is 5µg per g. |
| Protein and light-absorbing impurities | The absorbance divided by the path length in centimeters is not more than 0.25 in the range of 210 to 220nm and is not more than 0.07 in the range of 270 to 300nm. |
| TPC | <100cfu/g |
| Yeast & Mould | <50cfu/g |
| Escherichia coli (/10g) | absence |
| Conclusion : | The Quality of lactose product has the achieved scandard of USP40 after examination standard examination, and consequently meet the provision. |
