Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular USP, Macron Fine Chemicals™
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
MACR0616-12
0616-06
MACR0616-06
0616-88
MACR0616-26
0616-26
MACR0616-88
CAMK061606CS
1794.66
CAD
MK0616-06
CAMK061606
CAMK061688
CAJT0616-26
JT0616-26
MK061612
MK061688
Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular USP, Macron Fine Chemicals™
Citric acid monohydrate
Caution: Must be subjected to further processing during the preparation of injectable dosage forms.
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) |
MDL Number:
MFCD00149972 CAS Number: 5949-29-1 Merck Index: 13,02350 |
Specification Test Results
Meets U.S.P Requirements | |
GMP Manufactured Product | |
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)(by Karl Fischer titrn) | 7.5 - 9.0 % |
USP - Residue on Ignition | ≤0.1 % |
USP - Readily Carbonizable Substances | Passes Test |
USP - Sulfate (SO₄) | ≤0.015 % |
USP - Limit of Oxalic Acid | ≤0.036 % |
Solubility (5 in 50) | Passes Test |
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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