D(+)-Saccharose (von Rüben) NF, HPLE, multikompendial parenterale Qualität endotoxinarm, J.T.Baker®
Lieferant: Avantor
Synonyms:
Rübenzucker
, Kristallzucker
, D(+)-Sucrose
, Sucrose
, Haushaltszucker
, Rohrzucker
, 2-β-D-Fructofuranosyl-1-α-D-glucopyranosid
Veränderungsmanagement-Kategorie= R
6321-S1EA
0
CHF
6321-S1
6321-QM
6321-07
6321-06
6321-05
6321-N2
6321-KN
6321-ST
D(+)-Saccharose (von Rüben) NF, HPLE, multikompendial parenterale Qualität endotoxinarm, J.T.Baker®
D(+)-Saccharose
Suitable for use in the manufacture of parenteral dosage forms.
- High purity
- Low endotoxin
- Beet-derived
|
Formel:
C₁₂H₂₂O₁₁ MW: 342,3 g/mol |
MDL Number:
MFCD00006626 CAS-Nummer: 57-50-1 |
|
Spezifikation Testergebnisse
| 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 | |
| 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 | |
| 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 | |
| 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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