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Disodium succinate hexahydrate USP-NF PARENTEX PLUS 1KG
I7691SR10037305F724CV
USP-NF PARENTEX PLUS37305F7
6106-21-486836
C4H4Na2O4.6H2OMarch 2022
270.14February 2025
Sr.No.TestResultSpecification
1AppearanceWhite powderWhite crystals or white powder
2SolubilityCompliesFreely soluble in water
3Identification A (By IR)CompliesIR spectra of the sample should be concomitant with the IR spectra of the respective standard.
4Identification B (By Chromatographic identity)CompliesThe retention time of the major peak of the sample solution corresponds to that of the standard solution.
5Identification C (for Sodium)CompliesDense white precipitate should form
6Assay (on dried basis)99.40%98.0%-102.0%
7Limit of Sodium AcetateNot detectedNMT 0.2%
8Limit of Sodium MaleateNot detectedNMT 0.1%
9Limit of Sodium Fumarate0.001%NMT 0.1%
10sulfate (as SO4)Less than 0.019%NMT 0.019%
11Acidity & alkalinity8.647.0-9.0
12Loss on drying (120°C for 2hr)39.4%37.0%-41.0%
13Total aerobic microbial count (Bioburden)Less than 100 CFU/gmNMT 100 CFU/gm
14Total combined yeasts and molds count (Bioburden)Less than 50 CFU/gmNMT 50 CFU/gm
15E.coliAbsent/gmshould be absent /gm
16SalmonellaAbsent/10 gmshould be absent /10 gm
17Pseud. aeruginosaAbsent/gmshould be absent /gm
18Staphylococcus aureusAbsent/gmshould be absent /gm
19Bile-tolerant gram negative bacteriaAbsent/gmshould be absent /gm
20Bacterial endotoxinsLess than 6.0 EU/gmNMT 6.0 EU/gm
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF 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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