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D(+)-Galattosio ≥99%, Multi-Compendial basso valore di endotossine, J.T. Baker®

Fornitore: Avantor

6322-07EA 8950 CHF
6322-07 6322-05 6322-QM 6322-06
D(+)-Galattosio ≥99%, Multi-Compendial basso valore di endotossine, J.T. Baker®
D(+)-Galattosio
Formula: C₆H₁₂O₆
Peso molecolare: 180,16 g/mol
Densità: 1,72 g/cm³
MDL Number: MFCD00151230
CAS Number: 59-23-4
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Risultati del test di specificazione

GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Preserve in well-closed containers.
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
NF - Appearance of Solution Passes Test
NF - Acidity Passes Test
NF - Identification A (IR) Passes Test
NF - Identification B (TLC) Passes Test
NF - Optical Rotation [Å]²º^D (+) 78.0 - 81.5 Degree
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]²º^D (+) 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
Trace Impurities - Aluminum (Al), For Information Only
Trace Impurities - Arsenic (As), For Information Only
Trace Impurities - Cadmium (Cd), For Information Only
Trace Impurities - Chromium (Cr), For Information Only
Trace Impurities - Copper (Cu), For Information Only
Trace Impurities - Iridium (Ir), For Information Only
Trace Impurities - Iron (Fe), For Information Only
Trace Impurities - Lead (Pb), For Information Only
Trace Impurities - Manganese (Mn), For Information Only
Trace Impurities - Mercury (Hg), For Information Only
Trace Impurities - Molybdenum (Mo), For Information Only
Trace Impurities - Nickel (Ni), For Information Only
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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