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Disodium succinate hexahydrate CDMF PARENTEX PLUS 500GM
I3691SG50038865B427IV
CDMF PARENTEX PLUS38865B4
6106-21-489485
C4H4Na2O4.6H2OSeptember 2022
270.14August 2024
Sr.No.TestResultSpecification
1Appearance/DescriptionWhite crystals.White 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 (By HPLC, on dried basis)99.8%98.0% - 102.0%
7Limit of Sodium AcetateNot detectedNMT 0.2%
8Limit of Sodium MaleateNot detectedNMT 0.1%
9Limit of Sodium FumarateNot detectedNMT 0.1%
10Acidity & alkalinity /pH7.837.5 - 9.0
11Loss on drying,120°C39.4%37.0% to 41.0%
12Chloride (Cl)Less than 0.005%NMT 0.005%
13Sulphate (SO4)Less than 0.01%NMT 0.01%
14Phosphate (PO4)Less than 0.001%NMT 0.001%
15Nitrogen (N)Less than 0.001%NMT 0.001%
16Arsenic (As)Not detectedNMT 1.5ppm
17Cadmium(Cd)Not detectedNMT 0.2ppm
18Lead (pb)0.16ppmNMT 0.5ppm
19Mercury(Hg)Not detectedNMT 0.3ppm
20Nickel (Ni)0.42ppmNMT 2ppm
21Copper (Cu)0.00002%NMT 0.0005%
22Iron (Fe)0.0005%NMT 0.002%
23Potassium (K)0.023%NMT 0.05%
24Calcium (Ca)0.0024%NMT 0.005%
25UV absorbance profile (10mm cell)@260nm0.035NMT 0.08
26UV absorbance profile (10mm cell)@280nm0.030NMT 0.045
27Total aerobic microbial count (Bioburden)Less than 100 CFU/gmNMT 100 CFU/gm
28Total combined yeasts and molds count (Bioburden)Less than 50 CFU/gmNMT 50 CFU/gm
29E.coliAbsent/gmshould be absent /gm
30SalmonellaAvbsent/10 gmshould be absent /10 gm
31Pseud. aeruginosaAbsent/gmshould be absent /gm
32Staphylococcus aureusAbsent/gmshould be absent /gm
33Bile-tolerant gram negative bacteriaAbsent/gmshould be absent /gm
34Bacterial endotoxinsLess than 6 EU/gmNMT 6 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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