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Dibasic sodium phosphate dihydrate USP/Ph.Eur/BP PARENTEX 500GM
P1611SG50035642B201IU
USP/Ph.Eur/BP PARENTEX35642B2
10028-24-778391
Na2HPO4.2H2OSeptember 2021
177.99August 2024
Sr.No.TestResultSpecification
1DescriptionColorless crystals.White powder or colorless crystals.
2SolubilityPassesFreely soluble in water; practically insoluble in ethanol (96%)
3Identification (By chemical test)CompliesSolution should be slightly alkaline
4Identification (By Loss on drying)20.0%19.5% - 21.0%
5Identification (Sodium)CompliesA dense precipitate should form.
6Identification (Phosphate 1)CompliesA yellow precipitate that solution in 2N nitric acid and in 6N ammonium hydroxide should form.
7Identification (Phosphate 2)CompliesWith ammonium molybdate solution, acidified solutions should yield a yellow precipitate which should soluble in 6N ammonium hydroxide.
8Identification (Phosphate 3)CompliesA yellow colour should develop.
9Assay (on dry basis)98.7%98.0% - 100.5%
10Assay (Dried substance)98.7%98.0% 101.0% (Na2HPO4)
11Insoluble Substances0.06%NMT 0.4%
12Appearance of solutionPassesClear and colorless solution.
13Reducing substancesPassesThe color of the permanganate should not completely discharge
14Monosodium PhosphateLess than 2.5%NMT 2.5%
15ChloridesLess than 400ppmNMT 400ppm
16Sulphate (SO4)Less than 0.1%NMT 0.1%
17Arsenic (As)Less than 4ppmNMT 4ppm
18Iron(Fe)Less than 40ppmNMT 40ppm
19Loss on drying,130°C20.0%19.5% - 21.0%
20Total aerobic microbial countLess than 100 CFU/gmNMT 100 CFU/gm
21Total combined mold and yeasts countLess than 10 CFU/gmNMT 10 CFU/gm
22Bacterial endotoxin testLess than 2.5 EU/gmNMT 2.5 EU/gm
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur AND BP 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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