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Disodium Edetate USP/Ph.Eur PARENTEX PLUS 5KG
I0660SR50038183B630FV
USP/Ph.Eur PARENTEX PLUS38183B6
6381-92-686668
C10H14N2Na2O8.2H2OJune 2022
372.24May 2025
Sr.No.TestResultSpecification
1AppearanceWhite crystalline powder.White crystalline powder.
2SolubilityCompliesSoluble in water, practically insoluble in ethanol (96%)
3Identification (By IR)CompliesIR spectra of the sample should be concomitant with IR spectra of standard
4Identification (By chemical test 1)CompliesNo precipitate should produce.
5Identification (By chemical test 2)CompliesNo precipitate should produce.
6Identification (By chemical test 3)CompliesThe red color should discharge, leaving a yellowish solution.
7Identification (By chemical test 4)CompliesA dense white precipitate should form
8Appearance of SolutionCompliesSolution should be clear and colorless.
9pH4.354.0-5.5
10Impurity A (Nitrilotriacetic acid)0.03%NMT 0.1%
11Calcium (Ca)CompliesNo precipitate should form.
12Iron (Fe)Less than 80ppmNMT 80ppm
13Assay (on dried basis)99.5%99.0% - 101.0%
14Loss on drying at 150° for 6 Hr9.4%8.7%-11.4%
15Total aerobic microbial countLess than 100 CFU/gmNMT 100 CFU/gm
16Total Yeast & mold countLess than 10 CFU/gmNMT 10 CFU/gm
17Escherichia coliAbsent/gmshould be absent/gm
18Pseud. aeruginosaAbsent/gmshould be absent/gm
19Staphylococcus aureusAbsent/gmshould be absent/gm
20Bile-tolerant gram negative bacteriaAbsent/gmshould be absent/gm
21SalmonellaAbsent/10 gmshould be absent/10 gm
22Bacterial endotoxinsLess than 30 EU/gmNMT 30 EU/gm
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
Tested By
(Chemist - Quality Control)
Approved By
(Head - Quality Control)
Computer Generated Report - Does not require Signature.
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