D-(+)-Glucose monohydrate 97.5-102.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®

Supplier: Avantor
Warning

Synonyms: (2S,3R,4S,5S,6R)-6-(Hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetraol hydrate, Dextrose monohydrate

1913-07EA 59514.19 INR
1913-07 1913-06 1913-01
D-(+)-Glucose monohydrate 97.5-102.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®
D(+)-Glucose monohydrate
Formula: C₆H₁₂O₆·H₂O
MW: 198,17 g/mol
Melting Pt: 83 °C
Storage Temperature: Ambient
MDL Number: MFCD00149450
CAS Number: 5996-10-1
EINECS: 200-075-1
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Specification Test Results

Meets U.S.P Requirements
GMP Manufactured Product
Meets J.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets B.P. Chemical Specifications
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical Passes Test
USP - Identification A Passes Test
USP - Identification B Passes Test
USP - Identification C: Water (H₂O) 7.5 - 9.5 %
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 - Soluble Starch, Sulfites ≤15 ppm
USP - Conductivity (uS cm-1) ≤20 µS/cm
USP - Dextrin Passes Test
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) 7.0 - 9.5 %
JP - Identification 1 Passes Test
JP - Identification 2 Passes Test
JP - Water (H2O) 7.5 - 9.5 %
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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