Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular, GenAR® USP, Macron Fine Chemicals™
Supplier: Avantor Performance Materials
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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
7788-06EA
312.66
EUR
7788-06
C7788-88
Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular, GenAR® USP, Macron Fine Chemicals™
Citric acid monohydrate
Formula:
C₆H₈O₇.H₂O MW: 210,14 g/mol Melting Pt: 135…152 °C Density: 1,552 g/cm³ (20 °C) Flash Pt: 173,9 °C (closed cup) Storage Temperature: Ambient |
MDL Number:
MFCD00149972 CAS Number: 5949-29-1 EINECS: 201-069-1 Merck Index: 13,02350 |
Specification Test Results
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Meets J.P. Chemical Specifications | |
Preserve in Tight Containers | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (as C₆H₈O₇) (calculated on anhydrous basis) | 99.5 - 100.5 % |
USP - Clarity of Solution | Passes Test |
USP - Color of Solution | Passes Test |
USP - Identification | Passes Test |
USP - Water (H₂O) | 7.5 - 9.0 % |
USP - Residue on Ignition | ≤0.1 % |
USP - Readily Carbonizable Substances | Passes Test |
USP - Oxalic Acid | ≤0.036 % |
USP - Sulfate (SO₄) | ≤0.015 % |
EP/BP - Assay (as C₆H₈O₇) (calculated on anhydrous basis) | 99.5 - 100.5 % |
EP/BP - Identification B | Passes Test |
EP/BP - Identification E | Passes Test |
EP/BP - Oxalic Acid | ≤360 ppm |
EP/BP - Sulfate (SO₄) | ≤150 ppm |
EP/BP - Ash (sulfated) | ≤0.1 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Readily Carbonizable Substances | Passes Test |
EP/BP - Water (H₂O) | 7.5 - 9.0 % |
JP - Assay (C₆H₈O₇) (anhydrous basis) | 99.5 - 100.5 % |
JP - Clarity and Color of Solution | Passes Test |
JP - Heavy Metals (as Pb) | ≤10 ppm |
JP - Identification | Passes Test |
JP - Oxalic Acid | ≤360 ppm |
JP - Readily Carbonizable Substances | Passes Test |
JP - Residue on Ignition | ≤0.10 % |
JP - Sulfate (SO₄) | ≤150 ppm |
JP - Water (H₂O) | 7.5 - 9.0 % |
Endotoxin Concentration (IU/mg) | ≤0.5 |
Appearance (white to colorless crystals, granules or white crystalline | |
powder; efflorescent) | |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
Must be subjected to further processing during the preparation of | |
injectable dosage forms. | |
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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