Products

Lactose Monohydrate

Product Overview

  • Product Name:Lactose Monohydrate
  • Product Specifications:80mesh;100mesh;120mesh;200mesh
  • Active ingredient content:Lactose
  • CAS:10039-26-6
  • Packing:25kg/karft bag
  • Use:used for biological preparation
  • Safety measures:store in cool place
  • For crops:…
  • Quality warranty:CP\USP\BP

Product Description


Common Name: Lactose Monohydrate (Pharmaceutical and food grade)

Professional supplier in China

Usage: Mainly used for direct compression, granulation, capsule filling, granules filled, pill production, powder mixing, production of dry powder inhaler medical supplements.

Store: It should be store in room temperature, and sealed in a dry ventilated place.

Specification:

Test Method

1. Identification A

The analyse was performed according to USP30 ﹤197K﹥.

2. Identification B

The analyse was performed according to USP30 ﹤621﹥.

3. Identification C

The analyse was performed according to USP30.

4. Specific rotation

The analyse was performed according to USP30 ﹤781﹥.

5. Acidity or alkalinity

The analyse was performed according to USP30.

6. Loss on drying

The analyse was performed according to USP30 ﹤731﹥.

7. Water

The analyse was performed according to USP30 ﹤921﹥.

8. Residue on ignition

The analyse was performed according to USP30 ﹤281﹥.

9. Heavy metals

The analyse was performed according to USP30 ﹤231﹥.

10. Protein and light-absorbing impurities

The analyse was performed according to USP30 ﹤851﹥.

11. TPC, Escherichia coli, Mould and Yeast

Microbial Limit Tests were conducted with reference to the United States Pharmacopoeia, The National Formulary, USP30, 2007, General Chapter 61.

Test Results

Test Item Criterion Test Results
Identification A The infrared absorption spectrum of the sample is concordant with that of the standard. The infrared absorption spectrum of the sample was 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. The principal spot obtained from the Test solution corresponds in appearance and RF value to that obtained from Standard solution A. Standard solution B shows four clearly discernible spots.
Identification C A red color develops. It appeared red color.
Specific rotation +54.4°~+55.9°, calculate on the anhydrous basis. +55.4°
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. Add 0.3ml of phenolphthalein TS: the solution was colorless, and not more than 0.4 ml of 0.1 N sodium hydroxide was required to produce a red color.
Loss on drying The monohydrate form loses not more than 0.5% of its weight, and the modified monohydrate form loses not more than 1.0% of its weight. 0.03%
Water 4.5%~5.5% 4.9%
Residue on ignition Not more than 0.1% 0.05%
Heavy metals The limit is 5µg per g. Less than 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. The absorbance divided by the path length in centimeters was not more than 0.25 in the range of 210 to 220nm and was not more than 0.07 in the range of 270 to 300nm.

TPC, Escherichia coli, Mould and Yeast

Test items Criterion Test results
TPC (cfu/g) <100 <10
Yeast & Mould (cfu/g) <50 <10
Escherichia coli (/10g) absence Not detected

We also can offer you colorful label and carton with shipping mark according to your requirements.

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