D-(+)-Sucrose (beet-derived) NF, HPLE, multi-compendial parenteral grade low in endotoxins, J.T.Baker®
: Avantor
:57-50-1
:
:C₁₂H₂₂O₁₁
:MFCD00006626
:Management of Change (MOC) category = R
:342.3 g/mol
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- Bulk Pharmaceutical Chemical:Passes Test
- NF - Identification:Passes Test
- NF - Appearance of Solution:Passes Test
- NF - Color Value:≤45
- NF - Conductivity:≤35 µS/cm
- NF - Optical Rotation (+):66.3 - 67.0 Degree
- NF - Reducing Sugars:Passes Test
- NF - Sulfite (SO2):≤10 ppm
- NF - Loss on Drying at 105 ºC:≤0.1 %
- EP/BP - Identification A:Passes Test
- EP/BP - Identification B:Passes Test
- EP/BP - Identification C:Passes Test
- EP/BP - Appearance of Solution:Passes Test
- EP/BP - Conductivity, uS cm-1:≤35
- EP/BP - Optical Rotation (+):66.3 - 67.0 Degree
- EP/BP - Colour Value:≤45
- EP/BP - Reducing Sugars:Passes Test
- EP/BP - Sulfite (SO₂):≤10 ppm
- EP/BP - Loss on Drying at 105°C:≤0.1 %
- JP - Identification:Passes Test
- JP - Optical Rotation (+):66.3 - 67.0 Degree
- JP - Color Value:≤45
- JP - Clarity of Solution:Passes Test
- JP - Dextrins:Passes Test
- JP - Sulfite (SO₂):≤10 ppm
- JP - Conductivity, uS cm-1:≤35
- JP - Loss on Drying at 105°C:≤0.1 %
- JP - Reducing Sugars:Passes Test
- Assay (HPLC):≥99 %
- Endotoxin Concentration (EU/g):≤0.6
- 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 Molds (USP):≤100 cfu/g
- Microbial Testing - Total Aerobic Microbial Count (USP):≤100 cfu/g
- Microbial Testing -Bile tolerant gram-negative bacteria:None Detected
- Microbial Testing - Clostridia:None Detected
- Microbial Testing - Candida albicans:None Detected
- 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:For Information Only
- Trace Impurities - Molybdenum (Mo), For Information Only:For Information Only
- Trace Impurities - Nickel (Ni), For Information Only:For Information Only
- Trace Impurities - Osmium (Os), For Information Only:For Information Only
- Trace Impurities - Palladium (Pd), For Information Only:For Information Only
- Trace Impurities - Platinum (Pt), For Information Only:For Information Only
- Trace Impurities - Rhodium (Rh), For Information Only:For Information Only
- Trace Impurities - Ruthenium (Ru), For Information Only:For Information Only
- Trace Impurities - Vanadium (V), For Information Only:For Information Only
- Trace Impurities - Zinc (Zn), For Information Only:= 3000 ppm
- Residual Methanol:≤3000 ppm
- Residual Ethanol:≤5000 ppm
- Residual Isopropanol:≤5000 ppm
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Acetone ≥99%, TECHNICAL
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Vortex mixer, PV-1
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Glycerine 85% Ph. Eur.
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D-(-)-Mannitol analytical reagent
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Water, HiPerSolv CHROMANORM® for HPLC
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2-Propanol ≥99.8%, HiPerSolv CHROMANORM® for HPLC
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