D(+)-Saccharose (von Rüben) NF, HPLE, multikompendial parenterale Qualität endotoxinarm, J.T.Baker®

Lieferant: Avantor

Synonyms: RübenzuckerKristallzuckerD(+)-SucroseSucroseHaushaltszuckerRohrzucker2-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
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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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