Citric acid 99.5-100.5%, powder USP, Multi-Compendial, GMP, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
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Warning
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Synonyms:
2-Hydroxypropane-1,2,3-tricarboxylic acid
, Hydroxytricarballylic acid
Management of Change (MOC) category = R
0127-05
0127-07
BAKR0127-07
BAKR0127-05
CAJT0127-7EA
3564.26
CAD
CAJT0127-7
CAJT0127-5
JT0127-5
JT0127-7
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 |
MDL Number:
MFCD00011669 CAS Number: 77-92-9 Merck Index: 13,02350 |
Specification Test Results
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. |
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