Dextrose, anhydrous 97.5-102.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®

Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Warning

Synonyms: Corn sugarD-GlucoseD-(+)-DextroseGlucolinᴅ-(+)-Glucose(2R,3S,4R,5R)-2,3,4,5,6-PentahydroxyhexanalGlucoseDextrose

Management of Change (MOC) category = R

J.T. Baker®
1920-20 BAKR1920-09 BAKR1920-07 1920-09 1920-37 1920-07 1920-06 BAKR1920-20 1920-06 1920-05 BAKR1920-01 1920-39US 1920-37US BAKR1920-01 BAKR1920-05
CAJT1920-6EA 6821.49 CAD
JT1920-7 JT1920-39US JT1920-5 JT1920-6 CAJT1920-6 CAJT1920-5 JT1920-9 CAJT1920-9 JT1920-01 CAJT1920-20 CAJT1920-7 JT1920-20 JT1920-37 CAJT1920-01 JT1920-37US
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
MW: 180.16 g/mol
Melting Pt: 146 °C
Density: 1.54 g/cm³ (20 °C)
MDL Number: MFCD00148912
CAS Number: 50-99-7
Merck Index: 14,04459
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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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