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itwreagents
itwreagents
Minimum assay (G.C.): 99.5%
Identity according to Pharmacopoeias:: passes test
Density 25/25: 1.035-1.037
Density 20/20: 1.035-1.040
Range of Distillation (min. 95%): 184-189°C
Refractive Index n 20/D: 1.431-1.433
Maximum limit of impurities
Appearance: passes test
Acidity (Ph. Eur.): passes test
Acidity (USP, JP): passes test
Reducing substances: passes test
Residue on ignition (as SO4): 0.005 %
Chloride (Cl): 0.007%
Sulfate (SO4): 0.002%
Oxidizing substances: passes test
Residual solvents (Ph.Eur/USP): passes test
Glycerol: passes test
Ethylenglycol: 0.10%
Diethyleneglycol: 0.10%
Water (H2O): 0.1 %
itwreagents
Assay (G.C.): 98.0 - 102.0 %
Identity according to Pharmacopoeias:: passes test
Density 25/25: 0.917-0.923
Refractive Index n 25/D: 1.424-1.430
Maximum limit of impurities
Acidity (as CH3COOH): 0.013%
Residual solvents (Ph.Eur/USP): passes test
Organic impurities (G.C.):
Acetone: 0.1 %
2-Propanol: 0.1 %
Diacetone Alcohol: 0.1 %
4-Methyl-2-Pentanone: 0.1 %
4-Methyl-2-Pentanol: 0.1 %
Any other unspecified impurity: 0.1 %
Total: 1.0 %
Water (H2O): 0.5 %
itwreagents
Panreac 141008
Assay (Acidim.): 99.5-100.5%
Identity according to Pharmacopoeias:: passes test
Freezing point: ≥ 15.6°C
Maximum limit of impurities
Appearance of the substance: passes test
Insoluble matter in H2O: passes test
Non-volatile matter: 0.005 %
Reducing substances: passes test
Easily oxidable substances: passes test
Chloride (Cl): 0.001%
Sulfate (SO4): 0.001%
Residual solvents (Ph.Eur/USP): passes test
Aldehydes (as CH3CHO): 0.05%
Heavy metals (as Pb): 0.001 %
Fe: 0,0005 %
itwreagents
Panreac
Main substance (G.C.): 99.5%
Identity according to the Pharmacopoeia:: passes test
Density 25/25: ≤ 0.789
Density 20/20: 0.790-0.793
Maximum impurity limit
Appearance of the solution: Passed test
Acidity: passed test
Alkalinity: passed test
Substances insoluble in H2O: test passed
Non-volatile substances: 0.004 %
Reducing substance to KMnO4: test passed
Related Substances (G.C.)
Residual solvents (Ph.Eur/USP): test passed
Methanol: 0.05 %
2-propanol: 0.05 %
Benzene: 0.0002 %
Other impurities: 0.05 %
Ethanol (G.C.): 500 ppm
Water (H2O): 0.3%
itwreagents
Specifications:
Assay (Compl.): 95.0-101.0%
Identity according to Pharmacopoeias:: passes test
Appearance of solution: passes test
Insoluble matter in H2O: 0.02 %
Ammonium (NH4): 0.05%
Sulfate (SO4): 0.01%
Residual solvents (Ph.Eur/USP): passes test
Alkali and alkaline-earth metals: 0.5%
Water (H2O): 42.0-48.0 %
Fe: 0.001 %
Europe
Main substance: > 98.0%
Al content: > 9.0%
pH: 3.4
Loss on drying: < 2.0%
Phosphates (PO4): < 0.01%
Iron (Fe): < 0.008%
Heavy metals (such as Pb): < 0.001%
Europe
Main substance: 99.0-100.5%
Sulphated ash: 0.1%
Oxalic acid: 0.2%
Iron: 2ppm
Lead: 10ppm
itwreagents
Panreac 141679
Assay (Acidim.) calc. a.d.s.: 98.0-100.5%
Identity according to Pharmacopoeias:: passes test
pH of 5% solution: 8.7-9.4
Maximum limit of impurities
Appearance of solution: passes test
Insoluble matter in H2O: 0.025 %
Reducing substance to KMnO4: passes test
Loss on drying at 105°C: 1.0 %
Loss on drying at 130°C (USP): 5.0 %
Chloride (Cl): 0.005%
Nitrogen compounds (as N): 0.003%
Sulfate (SO4): 0.03%
Residual solvents (Ph.Eur/USP): passes test
Sodium di-Hydrogen Phosphate: passes test
As: 0.0001 %
Fe: 0.002 %
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