Avantor社(アバンター)のグローバルスタンダードに 対応する試薬・溶媒

ブドウ糖(無水)/Dextrose, anhydrous 97.5-102.0%（JT1920-01 ブドウ糖(無水)）の特徴

試験結果

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.