D-(+)-Galactose ≥99% (by HPLC), Multi-Compendial low in endotoxins, J.T.Baker®

Supplier: Avantor

Synonyms: D-Galactose, (2R,3S,4S,5R)-2,3,4,5,6-Pentahydroxyhexanal, (2R,3S,4S,5R)-Pentahydroxyhexanal

6322-05EA 979 GBP
6322-05 6322-06 6322-07
D-(+)-Galactose ≥99% (by HPLC), Multi-Compendial low in endotoxins, J.T.Baker®
D(+)-Galactose
Formula: C₆H₁₂O₆
MW: 180,16 g/mol
Density: 1,72 g/cm³
MDL Number: MFCD00151230
CAS Number: 59-23-4
https://digitalassets.avantorsciences.com/adaptivemedia/rendition?id=508b1d21a6801ddfb1a5f13a64cb06e6f95e8922&vid=db568466a51c978371ba4ad5db8379cbdfb05680&prid=web&clid=SAPDAM

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Specification Test Results

Meets B.P. Chemical Specifications
GMP Manufactured Product
Meets E.P. Chemical Specifications
Preserve in well-closed containers.
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
Trace Impurities - Osmium (Os), For Information Only
Trace Impurities - Palladium (Pd), For Information Only
Trace Impurities - Platinum (Pt), For Information Only
Trace Impurities - Rhodium (Rh), For Information Only
Trace Impurities - Ruthenium (Ru), For Information Only
Trace Impurities - Vanadium (V), For Information Only
Trace Impurities - Zinc (Zn), For Information Only
Residual Methanol ≤ 3000 ppm
Residual Ethanol ≤ 5000 ppm
Residual Isopropanol ≤ 5000 ppm
Residual Solvents: Only the Class 2 solvent Methanol and the Class 3
Solvent Ethanol are likely to be present. Each is tested and the
concentration reported for each batch.
Metallic Residues: No metal catalysts or metal reagents, as defined by
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of
this material.
Plant Derived

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