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Polyethylene glycol 400 USP-NF/Ph.Eur PARENTEX PLUS 2.5LT
I1216LC25035604G827HU
USP-NF/Ph.Eur PARENTEX PLUS35604G8
25322-68-379025
H(OCH2)nCH2OHAugust 2021
380-420July 2024
Sr.No.TestResultSpecification
1AppearanceClear to slightly hazy, practically colourless, slightly hygroscopic viscous liquid, having a slight characteristic odour, and a specific gravity at 25°C of 1.12Clear to slightly hazy, colourless or practically colourless, slightly hygroscopic viscous liquids, having a slight characteristic odour, and a specific gravity at 25°C of about 1.12
2SolubilityPassesMiscible with water, soluble in acetone, in alcohol, in chlororform, in ethylene glycol monoethyl ether, in ethyl acetate , in toluene, in methylene chloride,practically insoluble in fatty oils and in mineral oils. Insoluble in ether and in hexan
3Identification A (By Viscosity)CompliesTo comply the test
4Identification B (By Chemical test)CompliesAn abundant, white, crystalline precipitate is formed.
5Identification C (By Chemical test)CompliesThe liquid phase becomes blue.
6Appearance of solutionPassesThe solution is clear and not more intensely coloured than reference solution BY6.
7Completeness and colour of solutionPassesPasses test
8Assay95.74%95.0%-105.0% (Average molecular weight, 380-420)
9Acidity or alkalinityPassesPasses test
10Viscosity6.81 Centistokes6.8-8.0 Centistokes
11Kinematic Viscosity100.53 mm2.s-194 - 116 mm2.s-1
12Dynamic Viscosity113.7 mPa.s105 - 130 mPa.s
13Hydroxyl value287264-300
14Reducing substancesPassesPasses test
15FormaldehydeLess than 30ppmNMT 30ppm
16Ethylene glycol and Diethylene glycol0.018%0.25% max (Sum of ethylene glycol & diethylene glycol)
17Ethylene oxideNot detectedNMT 1ppm
18DioxanNot detectedNMT 10ppm (10 µg/g)
19Water0.1%NMT 2.0%
20Residue on ignition0.02%NMT 0.1%
21pH6.324.5-7.5
22Total aerobic microbial countLess than 100 CFU/mlNMT 100 CFU/ml
23Total Yeast & mold countLess than 10 CFU/mlNMT 10 CFU/ml
24E.coliAbsent/mlshould be absent/ml
25Staphylococcus aureusAbsent/mlshould be absent/ml
26Pseud. aeruginosaAbsent/mlshould be absent/ml
27Bile-tolerant gram negative bacteriaAbsent/mlshould be absent/ml
28Becterial endotoxins testLess than 2.5 EU/ml2.5 EU/ml
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, 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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