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 |
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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