Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular USP, Multi-Compendial, 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
, 2-Hydroxy-1,2,3-propanetricarboxilic acid
Management of Change (MOC) category = R
0115-32
BAKR0115-QM
BAKR0115-01
0115-37
0115-QM
BAKR0115-05
0115-07
0115-05
0115-34
BAKR0115-09
BAKR0115-07
0115-01
0115-39
0115-09
CAJT0115-QMCS
96.46
CAD
JT0115-34
JT0115-32
CAJT0115-QM
JT0115-5
JT0115-QM
JT0115-1
JT0115-7
CAJT0115-09
CAJT0115-5
JT0115-09
CAJT0115-7
JT0115-39
JT0115-37
CAJT0115-1
Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular USP, Multi-Compendial, J.T.Baker®
Citric acid monohydrate
Caution: Must be subjected to further processing during the preparation of injectable dosage forms.
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Formula:
C₆H₈O₇.H₂O MW: 210.14 g/mol Melting Pt: 135…152 °C Density: 1.54 g/cm³ (20 °C) Flash Pt: 173.9 °C (closed cup) |
MDL Number:
MFCD00149972 CAS Number: 5949-29-1 Merck Index: 14,04459 |
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Specification Test Results
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| Meets J.P. Chemical Specifications | |
| Preserve in Tight Containers | |
| 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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