Citric acid monohydrate 99.5-100.5% (by anhydrous basis), granular USP, Multi-Compendial, J.T.Baker®

Supplier: Avantor
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0116-07EA 818.34 EUR
0116-07 0116-37
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
Melting Pt: 135…152 °C
Density: 1,54 g/cm³
Flash Pt: 173,9 °C (closed cup)
MDL Number: MFCD00149972
CAS Number: 5949-29-1
Merck Index: 13,02350
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Specification Test Results

GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets J.P. Chemical Specifications
Meets U.S.P Requirements
Preserve in Tight Containers
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (C₆H₈O₇) (anhydrous basis) 99.5 - 100.5 %
USP - Clarity of Solution Passes Test
USP - Color of Solution Passes Test
USP - Identification Passes Test
USP - Oxalic Acid ≤ 0.036 %
USP - Readily Carbonizable Substances Passes Test
USP - Residue on Ignition ≤ 0.1 %
USP - Sulfate (SO₄) ≤ 0.015 %
USP - Water (H₂O) 7.5 - 9.0 %
EP/BP - Assay (C₆H₈O₇) (anhydrous basis) 99.5 - 100.5 %
EP/BP - Appearance of Solution Passes Test
EP/BP - Ash (sulfated) ≤ 0.1 %
EP/BP - Endotoxin Concentration, IU/mg ≤ 0.5
EP/BP - Identification B Passes Test
EP/BP - Identification E Passes Test
EP/BP - Oxalic Acid ≤ 360 ppm
EP/BP - Readily Carbonizable Substances Passes Test
EP/BP - Sulfate (SO₄) ≤ 150 ppm
EP/BP - Water (H₂O) 7.5 - 9.0 %
JP - Assay (HOC(COOH)(CH₂COOH)₂) (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 - Water (H₂O) 7.5 - 9.0 %
JP - Readily Carbonizable Substances Passes Test
JP - Residue on Ignition ≤ 0.10 %
JP - Sulfate (SO₄) ≤ 150 ppm
ACS - Iron (Fe) ≤ 3 ppm
Lead (Pb) ≤ 2 ppm
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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