Disodium Edetate USP/Ph.Eur PARENTEX PLUS 5KG Go Back

CASR

: 6381-92-6

Molecular Formula

: C10H14N2Na2O8.2H2O

Molecular Weight

: 372.24
Specifications  
Appearance/Description: White crystalline powder.
Solubility: Soluble in water, practically insoluble in ethanol (96%)
Identification (By IR): IR spectra of the sample should be concomitant with IR spectra of standard
Identification B (By Chemical test 1): No yellow precipitate should form.
Identification B (By Chemical test 2): No precipitate should form.
Identification B (By Chemical test 3): The red color should discharge, leaving a yellowish solution.
Identification C (By Chemical test): No precipitate should form.
Identification (Sodium): A dense white precipitate should form.
Appearance of Solution: Solution should be clear and colorless.
pH: 4.0-5.5
Impurity A (Nitrilotriacetic acid): NMT 0.1%
Calcium (Ca): No precipitate should form.
Iron (Fe): NMT 80ppm
Assay (on dried basis): 99.0% - 101.0%
Loss on drying at 150° for 6 Hr: 8.7%-11.4%
Total aerobic microbial count: NMT 100 CFU/gm
Total Yeast & mold count: NMT 10 CFU/gm
Escherichia coli: should be absent/gm
Pseud. aeruginosa: should be absent/gm
Staphylococcus aureus: should be absent/gm
Bile-tolerant gram negative bacteria: should be absent/gm
Salmonella: should be absent/10 gm
Bacterial endotoxins: NMT 30 EU/gm
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