Dextrose, anhydrous 97.5-102.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Warning
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1920-05EA
283.14
EUR
1920-05
1920-07
1920-06
1920-09
1920-20
1920-37
1920-39
1920-01
Dextrose, anhydrous 97.5-102.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®
D(+)-Glucose
Dextrose multi-compendial.
Make upstream processing steps more reliable and productive with pharmaceutical sugars from Avantor™ Performance Materials. These products are a reliable source of carbon and energy for cell cultures, and used as excipients, effectively stabilize valuable and delicate lyophilized proteins for injectable biopharmaceutical drugs.
Formula:
C₆H₁₂O₆ Melting Pt: 146 °C Density: 1,54 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00148912 CAS Number: 50-99-7 EINECS: 200-075-1 Merck Index: 14,04459 |
Specification Test Results
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
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 | |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Identification C: Water (H₂O) | ≤1.0 % |
USP - Assay (Anhydrous basis) | 97.5 - 102.0 % |
USP - Related substances: Maltose and isomaltose | ≤0.4 % |
USP - Related substances: Maltotriose | ≤0.2 % |
USP - Related substances: Fructose | ≤0.15 % |
USP - Related substances: Unspecified impurities, each | ≤0.10 % |
USP - Related substances: Total Impurities | ≤0.5 % |
USP - Color and Clarity of Solution | Passes Test |
USP - Dextrin | Passes Test |
USP - Soluble Starch, Sulfites | ≤15 ppm |
USP - Conductivity (uS cm-1) | ≤20 µS/cm |
USP - Endotoxin Concentration (EU/g) | ≤2.5 |
EP/BP - Identification A (Specific Rotation (+)) | 52.5 - 53.3 Degree |
EP/BP - Identification B | Passes Test |
EP/BP - Identification E | Passes Test |
EP/BP - Assay (C₆H₁₂O₆) (anhydrous substance) | 97.5 - 102.0 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Conductivity, uS cm-1 | ≤20 |
EP/BP - Related Substances: sum of impurities A and B | ≤0.4 % |
EP/BP - Related Substances: impurity C | ≤0.2 % |
EP/BP - Related Substances: impurity D | ≤0.15 % |
EP/BP - Related Substances: unspecified impurities, each | ≤0.10 % |
EP/BP - Related Substances: total impurities | ≤0.5 % |
EP/BP - Dextrins | Passes Test |
EP/BP - Soluble starch, sulfite | ≤15 ppm |
EP/BP - Water (H₂O) | ≤1.0 % |
JP - Identification 1 | Passes Test |
JP - Identification 2 | Passes Test |
JP - Water (H₂O) | ≤1.0 % |
JP - Assay (Anhydrous basis) | 97.5 - 102.0 % |
JP - Maltose and isomaltose | ≤0.4 % |
JP - Maltotriose | ≤0.2 % |
JP - Fructose | ≤0.15 % |
JP - Unspecified Impurities, each | ≤0.10 % |
JP - Total Impurities | ≤0.5 % |
JP - Color and Clarity of Solution | Passes Test |
JP - Soluble Starch, Sulfites | ≤15 ppm |
JP - Conductivity (uS cm-1) | ≤20 µS/cm |
JP - Dextrin | Passes Test |
JP - Heavy Metals (as Pb) | ≤4 ppm |
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |
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. |
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