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Polyethylene glycol 400 USP-NF/Ph.Eur PARENTEX PLUS 2.5LT
I1216LC25039166G803KV
USP-NF/Ph.Eur PARENTEX PLUS39166G8
25322-68-389721
H(OCH2)nCH2OHNovember 2022
380-420October 2025
Sr.No.TestResultSpecification
1AppearanceClear, colourless, slightly hygroscopic viscous liquids, having a slight characteristic odour, and a specific gravity at 25°C of 1.11.Clear 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
2SolubilityCompliesMiscible 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 hexane
3Identification A (By Viscosity)CompliesKinematic viscosity should be between 94 &116 mm2.S-1 and dynamic viscosity should be between 105-130 mPa.s at 20°C
4Identification B (By Chemical test)CompliesAn abundant, white, crystalline precipitate is formed.
5Identification C (By Chemical test)CompliesThe liquid phase becomes blue.
6Appearance of solutionCompliesThe solution is clear and not more intensely coloured than reference solution BY6.
7Completeness and colour of solutionCompliesclear solution
8Assay102.4%95.0%-105.0% (Average molecular weight, 380-420)
9Acidity or alkalinityCompliesNMT 0.1ml of 0.1M sodium hydroxide should required to change the colour of the indicator to blue.
10Viscosity7.2 Centistokes6.8-8.0 Centistokes
11Kinematic Viscosity98.6 mm2.s-194 - 116 mm2.s-1
12Dynamic Viscosity110.4 mPa.s105 - 130 mPa.s
13Hydroxyl value286264-300
14Reducing substancesCompliesThe solution is not more intensely coloured than reference solution R3.
15FormaldehydeLess than 30ppmNMT 30ppm
16Ethylene glycol and Diethylene glycol0.01%NMT 0.25% (Sum of ethylene glycol & diethylene glycol)
17Ethylene oxide0.3ppmNMT 1ppm
18DioxanNot detectedNMT 10ppm (10 µg/g)
19Water0.1%NMT 2.0%
20Residue on ignition0.003%NMT 0.1%
21pH6.24.5-7.5
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/mlNMT 2.5 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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