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

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

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

0616-12 0616-88 MACR0616-06
MK061612CS 362.24 USD InStock
MK061612 MK061688 MK0616-06 JT0616-26
Citric acid monohydrate ≥99.5% (by anhydrous basis), granules USP, Macron Fine Chemicals™
Citric acid monohydrate
Granular. GMP manufactured.

Precaución: 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)
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
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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