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

Supplier: AVANTOR PERFORMANCE MATERIALS

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0115-01EA 13376.32 INR InStock
0115-01 0115-05 0115-07 0115-09
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.


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)
Storage Temperature: Ambient
 MDL Number: MFCD00149972
CAS Number: 5949-29-1
EINECS: 200-075-1
Merck Index: 13,02350
https://qa.digitalassets.avantorsciences.com/adaptivemedia/rendition?id=3160681f96abd248f56672a96b72cc5f6e9d89a2&vid=7b314061a5750f43f24baa4a1fcae953ea33bce4&prid=web&clid=SAPDAM
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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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