Beschreibung
D(+)-Lactose 1-hydrate (USP-NF, BP, Ph. Eur.) pure, pharma grade
Content: 5 KGM
Physical Description:
solid
Quality Name: pure, pharma grade
Specification: Identity according to Pharmacopoeias: passes test
Specific rotation a 20/D c= 10 (in H2O): +54.4 - +55.9°
?maximum limit of impurities:
ABS ? 270-300 nm 1% sol. in H2O: 0.07
ABS ? 400 nm 10% sol. in H2O: 0.04
ABS ? 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%
Sulfate (SO4): 0.02%
Residual solvents (Ph.Eur/USP): passes test
Water (H2O): 4.5-5.5 %
Total aerobic microbial count (TAMC): 100 cfu/ml
Yeasts and molds: 50 cfu/g
Escherichia coli: negative
Salmonella: negative
Microbial limits: negative
Heavy metals (as Pb): 0.0005%
Product obtained from animal milk with collection in the same conditions that the milk obtained for human consumption.:
Content: 5 KGM
Physical Description:
solid
Quality Name: pure, pharma grade
Specification: Identity according to Pharmacopoeias: passes test
Specific rotation a 20/D c= 10 (in H2O): +54.4 - +55.9°
?maximum limit of impurities:
ABS ? 270-300 nm 1% sol. in H2O: 0.07
ABS ? 400 nm 10% sol. in H2O: 0.04
ABS ? 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%
Sulfate (SO4): 0.02%
Residual solvents (Ph.Eur/USP): passes test
Water (H2O): 4.5-5.5 %
Total aerobic microbial count (TAMC): 100 cfu/ml
Yeasts and molds: 50 cfu/g
Escherichia coli: negative
Salmonella: negative
Microbial limits: negative
Heavy metals (as Pb): 0.0005%
Product obtained from animal milk with collection in the same conditions that the milk obtained for human consumption.: