D-(+)-Galactose ≥99% (by HPLC), Multi-Compendial low in endotoxins, J.T.Baker®
: Avantor
:59-23-4
:
:C₆H₁₂O₆
:MFCD00151230
:180.16 g/mol
:1.72 g/cm³
- Residual Methanol:≤ 3000 ppm
- Residual Ethanol:≤ 5000 ppm
- Residual Isopropanol:≤ 5000 ppm
- CAUTION: For Manufacturing, processing or repackaging:Passes Test
- Bulk Pharmaceutical Chemical:Passes Test
- NF - Assay (C6H12O6 ) (anhydrous basis):98.0 - 102.0 %
- NF - Appearance of Solution:Passes Test
- NF - Acidity:Passes Test
- NF - Identification A (IR):Passes Test
- NF - Identification B (HPLC):Passes Test
- NF - Identification C:Passes Test
- NF - Optical Rotation [Å]²ºD (+):78.0 - 81.5 Degree
- NF - Related Substances: Lactose and 1,6-galactosylgalactose:≤ 0.6 %
- NF - Related Substances: Galacturonic acid:≤ 0.6 %
- NF - Related Substances: Dextrose:≤ 0.6 %
- NF - Related Substances: Tagatose:≤ 0.6 %
- NF - Related Substances: Dulcitol:≤ 0.6 %
- NF - Related Substances: Arabinose:≤ 0.6 %
- NF - Related Substances: Any unspecified impurity, each:≤ 0.2 %
- NF - Related Substances: Total impurities:≤ 1.0 %
- NF - Barium (Ba):Passes Test
- NF - Lead (Pb):≤ 0.5 ppm
- NF - Water (H₂O):≤ 1.0 %
- NF - Residue on Ignition:≤ 0.1 %
- EP/BP - Assay (C₆H₁₂O₆)(anhydrous basis):97.0 - 102.0 %
- EP/BP - Appearance of Solution:Passes Test
- EP/BP - Acidity or Alkalinity:Passes Test
- EP/BP - Identification A (IR):Passes Test
- EP/BP - Proteins:≤ 0.1 %
- EP/BP - Related Substances: Sum of Impurities A and B:≤ 1.0 %
- EP/BP - Related Substances:Unspecified impurities, each:≤ 0.3 %
- EP/BP - Related Substances:Total impurities:≤ 2.0 %
- EP/BP - Specific Optical Rotation [Å]²ºD (+):78.0 - 81.5 Degree
- EP/BP - Water (H₂O):≤ 1.0 %
- EP/BP - Sulfated Ash:≤ 0.1 %
- EP/BP - TAMC (cfu/g):≤ 100 cfu/g
- Appearance:Passes Test
- Endotoxin Concentration (EU/g):≤ 2.5
- Glucose:≤ 0.1 %
- Purity (HPLC):≥ 99 %
- Residue on Ignition:≤ 0.05 %
- Microbial Testing - Salmonella (USP):None Detected
- Microbial Testing - E. coli (USP):None Detected
- Microbial Testing - Staphylococcus aureus (USP):None Detected
- Microbial Testing - Pseudomonas aeruginosa (USP):None Detected
- Microbial Testing - Total Yeast and Mold (USP):≤ 100 cfu/g
- Microbial Testing - Total Aerobic Microbial Count (USP):≤ 100 cfu/g
- Solution Clarity (300 mg/mL):Passes Test
- Solution Color, APHA - For Information Only:For Information Only
- Trace Impurities - Aluminum (Al), For Information Only:For Information Only
- Trace Impurities - Arsenic (As), For Information Only:For Information Only
- Trace Impurities - Cadmium (Cd), For Information Only:For Information Only
- Trace Impurities - Chromium (Cr), For Information Only:For Information Only
- Trace Impurities - Copper (Cu), For Information Only:For Information Only
- Trace Impurities - Iridium (Ir), For Information Only:For Information Only
- Trace Impurities - Iron (Fe), For Information Only:For Information Only
- Trace Impurities - Lead (Pb), For Information Only:For Information Only
- Trace Impurities - Manganese (Mn), For Information Only:For Information Only
- Trace Impurities - Mercury (Hg), For Information Only:= 3000 ppm
- Trace Impurities - Molybdenum (Mo), For Information Only:= 5000 ppm
- Trace Impurities - Nickel (Ni), For Information Only:= 5000 ppm
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