Citric acid 99.5-100.5%, powder USP, Multi-Compendial, GMP, J.T.Baker®
Supplier: Avantor
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Warning
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Synonyms:
2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid
0127-07EA
855
GBP
0127-07
0127-05
Citric acid 99.5-100.5%, powder USP, Multi-Compendial, GMP, J.T.Baker®
Citric acid
Formula:
HOC(COOH)(CH₂COOH)₂ MW: 192,13 g/mol Boiling Pt: 310 °C (1013 hPa) Melting Pt: 149…151 °C Density: 1,67 g/cm³ Storage Temperature: Ambient |
MDL Number:
MFCD00011669 CAS Number: 77-92-9 EINECS: 201-069-1 REACH: 01-2119457026-42-0000 Merck Index: 13,02350 |
Specification Test Results
GMP Manufactured Product | 99.5 - 100.5% |
Meets B.P. Chemical Specifications | Passes Test |
Meets E.P. Chemical Specifications | Passes Test |
Meets J.P. Chemical Specifications | Passes Test |
Meets U.S.P Requirements | ≤0.1% |
Preserve in Tight Containers | ≤0.036% |
CAUTION: For Manufacturing, processing or repackaging | ≤0.015% |
Bulk Pharmaceutical Chemical | Passes Test |
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. |
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