Lactose Monohydrate CAS5989-81-1
Test items |
Standard Code |
Results |
Identification A |
The infrared absorption spctrum of the sample is concordan with that of the standard |
Complies |
Identification B |
The principal spot obtained from the test solution cooresponds 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,disrefarding any spots at the origin. |
Complies |
Residue on ignition |
NMT 0.1% |
0.03% |
Heavy metals |
NMT 5ug per g. |
Complies |
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 400nm.The absorbance divided by the path lengh,in cm,is NMT 0.04
|
Complies
0.01 |
Optical rotation |
+54.4°-55.9°,calculate on the anhydrous basis,determined at20 |
+55.1° |
Acidity or alkalinity |
Add 0.3ml of phenolphthalein TS:the solution is colorless,and not more than 0.4ml of 0.1N sodium hydroxide is required to produce a pink or red color |
Complies |
Loss on drying |
Dry a sample at 80°for 2 h.NMT 0.5% |
0.05% |
Water |
4.5%-5.5% |
5.0% |
Protein and light-absorbing impurities |
210-220nm: NMT 0.25 270-300nm:NMT 0.07 |
0.03 0.01 |
TAMC(cfu/g) |
<100 |
<10 |
Mold and Yeasts(cfu/g) |
<50 |
<10 |
Escherichia Coli.(/10g) |
absence |
Not detected |
Conclusion |
The quality of lactose product has the achieved standard of USP40 after examination standard examination,and consequently meet the provisio. |