Lactose monohydrate USP, NF, Ph. Eur., BP, pure
Supplier: PanReac AppliChem
Certificates
About this item
Synonyms: Milk sugar, Lactobiose
CAS Number:10039-26-6
:
Formula:C₁₂H₂₂O₁₁·1H₂O
Molecular Weight:360.32 g/mol
Melting Pt:223
Specifications
- Environmentally Preferable:
Specifications
Specification Test Results
- Identity according to Pharmacopoeias:Passes test
- Specific rotation [a] 20/D c= 10 (in H₂O) :+54,4 to +55,9°
- ABS at λ 270 - 300 nm 1% sol. in H₂O:0,07
- ABS at λ 400 nm 10% sol. in H₂O:0,04
- ABS at λ 210 - 220 nm 1% sol. in H₂O:0,25
- Appearance of solution:Passes test
- Acidity or alkalinity:Passes test
- Insoluble matter in H₂O:Passes test
- Loss on drying at 80 °C:0,5%
- Residue on ignition (as SO₄):0,1%
- Chloride (Cl) :0,01%
- Sulphate (SO₄) :0,02%
- Residual solvents (Ph. Eur/USP):Passes test
- Water (H₂O):4,5 - 5,5%
- Total aerobic microbial count (TAMC):100 cfu /g
- Yeasts and molds:50 cfu/g
- Escherichia coli:Negative
- Salmonella:Negative
- Heavy metals (as Pb):0,0005%
- Cadmium (Cd):0,5 ppm
- Lead (Pb):5 ppm
- Arsenic (As):1 ppm
- Mercury (Hg):1,5 ppm
- Cobalt (Co):5 ppm
- Vanadium (V):10 ppm
- Nickle (Ni):20 ppm
- Thallium (Tl):5 ppm
- Gold (Au):10 ppm
- Palladium (Pd):10 ppm
- Iridium (Ir):10 ppm
- Osmium (Os):10 ppm
- Rhodium (Rh):10 ppm
- Ruthenium (Ru):10 ppm
- Selenium (Se):15 ppm
- Silver (Ag):15 ppm
- Platinum (Pt):10 ppm
- Lithium (Li):55 ppm
- Antimony (Sb):120 ppm
- Barium (Ba):140 ppm
- Molybdenum (Mo):25 ppm
- Copper (Cu):250 ppm
- Tin (Sn):600 ppm
- Chromium (Cr):25 ppm
- pH (50 g/l):4 - 6
- Appearance:Small white crystals
- Solubility:Soluble in water 216 g/l at 20 °C
Specification Test Results
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