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Disodium succinate hexahydrate CDMF PARENTEX PLUS 500GM
I3691SG50037281B422CV
CDMF PARENTEX PLUS37281B4
6106-21-486360
C4H4Na2O4.6H2OMarch 2022
270.14February 2024
Sr.No.TestResultSpecification
1Appearance/DescriptionWhite powder.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)99.5%98.0% - 102.0%
7Limit of Sodium AcetateNot detectedNMT 0.2%
8Limit of Sodium MaleateNot detectedNMT 0.1%
9Limit of Sodium Fumarate0.0005%NMT 0.1%
10Acidity & alkalinity /pH8.577.5 - 9.0
11Loss on drying,120°C39.9%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)0.3 ppmNMT 1.5ppm
17Cadmium(Cd)Not detectedNMT 0.2ppm
18Lead (pb)Not detectedNMT 0.5ppm
19Mercury(Hg)Not detectedNMT 0.3ppm
20Nickel (Ni)Not detectedNMT 2ppm
21Copper (Cu)Not detectedNMT 0.0005%
22Iron (Fe)0.00004%NMT 0.002%
23Potassium (K)0.001%NMT 0.05%
24Calcium (Ca)0.00007%NMT 0.005%
25UV absorbance profile (10mm cell)@260nm0.038NMT 0.08
26UV absorbance profile (10mm cell)@280nm0.021NMT 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
30SalmonellaAbsent/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.
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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