Lactose monohydrate USP, NF, BP, Ph. Eur., pure

Supplier: PanReac AppliChem

Synonyms: Milk sugar, Lactobiose

141375.0914 141375.1211
APPC141375.0914EA 552 SGD
APPC141375.0914 APPC141375.1211
Lactose monohydrate USP, NF, BP, Ph. Eur., pure
Lactose monohydrate

Synonyms: 4-O-b-D-Galactopyranosyl-D-Glucose, milk sugar.

Formula: C₁₂H₂₂O₁₁·1H₂O
MW: 360,32 g/mol
CAS Number: 10039-26-6

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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

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