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 R_F 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.