D-(+)-Sucrose (beet-derived) NF, HPLE, multi-compendial parenteral grade low in endotoxins, J.T.Baker®
Supplier: Avantor
Management of Change (MOC) category = R
6321-KN
6321-N2
6321-S1
6321-05EA
372.16
EUR
6321-05
6321-06
6321-07
6321-KN
6321-N2
6321-S1
D-(+)-Sucrose (beet-derived) NF, HPLE, multi-compendial parenteral grade low in endotoxins, J.T.Baker®
D(+)-Sucrose
Suitable for use in the manufacture of parenteral dosage forms.
- High purity
- Low endotoxin
- Beet-derived
Formula:
C₁₂H₂₂O₁₁ |
MDL Number:
MFCD00006626 CAS Number: 57-50-1 |
Specification Test Results
Meets N.F. Requirements | |
GMP Manufactured Product | |
Meets E.P. Chemical Specifications | |
Meets B.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
CAUTION: For Manufacturing, processing or repackaging | |
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 |
|
Residual Methanol | ≤3000 ppm |
Residual Ethanol | ≤5000 ppm |
Residual Isopropanol | ≤5000 ppm |
Residual Solvents: Only the Class 2 solvent Methanol and the Class 3 | |
solvents Ethanol and Isopropanol are likely to be present. Each is | |
tested and the concentration reported for each batch. | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
impurities for this product is available on the associated Product | |
Regulatory Data Sheet and elemental impurity profile report. | |
Suitable for use in the manufacture of parenteral dosage forms. |
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