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

クエン酸(無水)/Citric acid 99.5-100.5%, powder（JT0127-5 クエン酸(無水)）の特徴

試験結果

GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets J.P. Chemical Specifications
Meets U.S.P Requirements
Meets E.P. Chemical Specifications
Preserve in Tight Containers
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (HOC(COOH)(CH₂COOH)₂) (anhydrous basis) 99.5 - 100.5 %
USP - Clarity of Solution Passes Test
USP - Color of Solution Passes Test
USP - Identification Passes Test
USP - Residue on Ignition ≤0.1 %
USP - Oxalic Acid ≤0.036 %
USP - Sulfate (SO₄) ≤0.015 %
USP - Readily Carbonizable Substances Passes Test
USP - Identification C: Water (H₂O) ≤1.0 %
EP/BP - Assay (HOC(COOH)(CH₂COOH)₂) (anhydrous basis) 99.5 - 100.5 %
EP/BP - Identification B Passes Test
EP/BP - Identification E Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - Readily Carbonizable Substances Passes Test
EP/BP - Oxalic Acid ≤360 ppm
EP/BP - Sulfate (SO₄) ≤150 ppm
EP/BP - Water (H₂O) ≤1.0 %
EP/BP - Ash (sulfated) ≤0.1 %
EP/BP - Endotoxin Concentration, <0.5 IU/mg Passes Test
JP - Assay (HOC(COOH)(CH₂COOH)₂) (anhydrous basis) 99.5 - 100.5 %
JP - Clarity and Color of Solution Passes Test
JP - Identification Passes Test
JP - Sulfate (SO₄) ≤150 ppm
JP - Oxalic Acid ≤360 ppm
JP - Heavy Metals (as Pb) ≤10 ppm
JP - Readily Carbonizable Substances Passes Test
JP - Residue on Ignition ≤0.10 %
JP - Water (H₂O) ≤1.0 %
Total Aerobic Microbial Count, For Information Only
Total Yeasts and Molds Count, For Information Only
E. coli Negative
P. aureginosa Negative
Must be subjected to further processing during the preparation of injectable dosage forms
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product.