Citric acid monohydrate 99.5-100.5% (alkalimetric, calculated on anhydrous substance), crystals, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, ACS, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS
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Synonyms: Hydroxytricarballylic acid2-Hydroxy-1,2,3-propanetricarboxilic acid

1.37003.9029EA 0 EUR
1.37003.9029 1.37003.5000 1.37003.9012
Citric acid monohydrate 99.5-100.5% (alkalimetric, calculated on anhydrous substance), crystals, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, ACS, SAFC®
Citric acid monohydrate

Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).


Certifications: Corresponds to Ph. Eur., BP, JP, USP, ACS

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
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Specification Test Results

Assay (alkalimetric, calculated on anhydrous substance) 99.5 - 100.5 %
Identity (IR-spectrum) passes test
Appearance white to almost white or colorless crystals
Appearance of solution (200 g/l; water) clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
In water insoluble matter # ≤ 0.005 %
Chlorid (Cl) # ≤ 0.001 %
Phosphat (PO4) # ≤ 0.001 %
Sulfate (SO₄) ≤ 20 ppm
Heavy metals (as Pb) ≤ 10 ppm
Al (Aluminium) ≤ 0.2 ppm
Fe (Iron) # ≤ 3 ppm
Pb (Lead) # ≤ 2 ppm
Oxalates (as C₂H₂O₄) ≤ 360 ppm
Residual solvents (ICH (Q3C)) excluded by manufacturing process
Readily carbonisable substance passes test
Sulfated ash (600 °C) ≤ 0.02 %
Water (according to Karl Fischer) 7.5 - 9.0 %
Total aerobic microbial count (TAMC) ≤ 100 CFU/g
Total combined yeasts/moulds count (TYMC) ≤ 10 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g) passes test
Candida albicans (absent in 1 g) passes test
Escherichia coli (absent in 1 g) passes test
Pseudomonas aeruginosa (absent in 1 g) passes test
Salmonella (absent in 10 g) passes test
Staphylococcus aureus (absent in 1 g) passes test
Bacterial endotoxins 10
# Additional requirements by ACS

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