Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
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Warning
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Synonyms:
2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid, 2-Hydroxy-1,2,3-propanetricarboxilic acid
Management of Change (MOC) category = R
LP01-12EA
0
INR
LP01-12
LP01-S1
Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular USP, Multi-Compendial, J.T.Baker®
Citric acid monohydrate
Formula:
C₆H₈O₇.H₂O MW: 210,14 g/mol |
MDL Number:
MFCD00149972 CAS Number: 5949-29-1 |
Specification Test Results
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
GMP Manufactured Product | |
Meets E.P. Chemical Specifications | |
Meets B.P. Chemical Specifications | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Clarity of Solution | Passes Test |
USP - Color of Solution | Passes Test |
USP - Identification | Passes Test |
USP - Water (H₂O) | 7.5 - 9.0 % |
USP - Readily Carbonizable Substances | Passes Test |
USP - Residue on Ignition | ≤0.1 % |
USP - Sulfate (SO₄) | ≤0.015 % |
USP - Oxalic Acid | ≤0.036 % |
USP - Assay (C₆H₈O₇) (anhydrous basis) | 99.5 - 100.5 % |
EP/BP - Assay (C₆H₈O₇) (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) | 7.5 - 9.0 % |
EP/BP - Ash (sulfated) | ≤0.1 % |
EP/BP - Endotoxin Concentration, IU/mg | ≤0.5 |
JP - Assay (C₆H₈O₇) (anhydrous basis) | 99.5 - 100.5 % |
JP - Identification | Passes Test |
JP - Sulfate (SO₄) | ≤150 ppm |
JP - Oxalic Acid | ≤360 ppm |
JP - Clarity and Color of Solution | Passes Test |
JP - Heavy Metals (as Pb) | ≤10 ppm |
JP - Water (H₂O) | 7.5 - 9.0 % |
JP - Readily Carbonizable Substances | Passes Test |
JP - Residue on Ignition | ≤0.10 % |
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. | |
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. |
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