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Update to Avantor’s response to the coronavirus (COVID-19) pandemic

Citric acid monohydrate ≥99.5% (by anhydrous basis), granules, GenAR® USP, Macron Fine Chemicals™

Supplier: AVANTOR PERFORMANCE MATERIALS US
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Management of Change (MOC) category = R

7788-06 7788-88
MK778806CS 1565.41 USD InStock
MK778806 MK778888
Citric acid monohydrate ≥99.5% (by anhydrous basis), granules, GenAR® USP, Macron Fine Chemicals™
Citric acid monohydrate
Granular. GMP manufactured.


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
https://qa.digitalassets.avantorsciences.com/adaptivemedia/rendition?id=3160681f96abd248f56672a96b72cc5f6e9d89a2&vid=7b314061a5750f43f24baa4a1fcae953ea33bce4&prid=web&clid=SAPDAM
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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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