JT Baker® 0127-05 Citric Acid, Anhydrous, Powder, USP Grade, Multi-Compendial Grade, 2.5Kg Poly Bottle (Case of 4)
- Case of 4 x 2.5Kg Poly Bottles
- Manufacturer Part No: JT-0127-05
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Details
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
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 - Heavy Metals (as Pb) | <= 0.001 % |
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 - Heavy Metals (as Pb) | <= 10 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. |
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Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
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 - Heavy Metals (as Pb) | <= 0.001 % |
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 - Heavy Metals (as Pb) | <= 10 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. |