Citronensäure Monohydrat 99,5-100,5% (alkalimetrisch, berechnet an wasserfreien Substanzen), Kristalle, EMPROVE® EXPERT USP, JP, ACS, Ph. Eur., BP for biopharmaceutical production, SAFC®

: MERCK PRODUCTION CHEMICALS

Citronensäure Monohydrat 99,5-100,5% (alkalimetrisch, berechnet an wasserfreien Substanzen), Kristalle, EMPROVE® EXPERT USP, JP, ACS, Ph. Eur., BP for biopharmaceutical production, SAFC®

: MERCK PRODUCTION CHEMICALS

: 2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid, 2-Hydroxy-1,2,3-propanetricarboxilic acid

:5949-29-1

:C₆H₈O₇.H₂O

:MFCD00149972

:1.552 g/cm³ (20 °C)

:210.14 g/mol

:135…152 °C

:173.9 °C (geschlossener Tiegel)

:13,02350

:201-069-1

:GHS07

:Raumtemperatur

Environmentally Preferable:

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