| Polyethylene glycol 400 USP/Ph.Eur 2LT | |||
| 93216LC200 | 428667102BX | ||
| USP/Ph.Eur | 4286671 | ||
| 25322-68-3 | 101112 | ||
| H(OCH2)nCH2OH | February 2024 | ||
| 380-420 | January 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Clear, colourless slightly hygroscopic viscous liquids, having a slight, characteristic odour, and specific gravity at 25°C is 1.12 | 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 |
| 2 | Solubility | Complies | Miscible with water, soluble in acetone,in alcohol,in chlororform, in ethylene glycol monoethyl ether,in ethyl acetate , in toluene,and in methylene chloride,practically insoluble in fatty oils and in mineral oils.Insoluble in ether and in hexane |
| 3 | Identification A (By Viscosity) | Complies | Kinematic viscosity should be between 94 &116 mm2.S 1 and dynamic viscosity should be between 105 & 130 mPa.s at 20°C |
| 4 | Identification B (By Chemical test) | Complies | An abundant, white, crystalline precipitate is formed. |
| 5 | Identification C (By Chemical test) | Complies | The liquid phase becomes blue. |
| 6 | Appearance of solution | Complies | The solution is clear and not more intensely coloured than reference solution BY6. |
| 7 | Completeness and colour of solution | Complies | clear solution |
| 8 | Assay | 98.78% | 95.0%-105.0% (Average molecular weight, 380-420) |
| 9 | Acidity or alkalinity | Complies | NMT 0.1ml of 0.1M sodium hydroxide should required to change the colour of the indicator to blue |
| 10 | Viscosity | 7.2 Centistokes | 6.8-8.0 Centistokes |
| 11 | Kinematic Viscosity | 96.4 mm2.s-1 | 94 - 116 mm2.s-1 |
| 12 | Dynamic Viscosity | 108 mPa.s | 105 - 130 mPa.s |
| 13 | Hydroxyl value | 285.9 | 264-300 |
| 14 | Reducing substances | Complies | The solution is not more intensely coloured than reference solution R3 |
| 15 | Formaldehyde | Less than 30ppm | NMT 30ppm |
| 16 | Ethylene glycol and Diethylene glycol | 0.07% | NMT 0.25% (Sum of ethylene glycol & diethylene glycol) |
| 17 | Ethylene oxide | Not detected | NMT 1ppm |
| 18 | Dioxan | Not detected | NMT 10ppm (10 µg/g) |
| 19 | Water | 0.3% | NMT 2.0% |
| 20 | Residue on ignition | 0.001% | NMT 0.1% |
| 21 | pH | 4.68 | 4.5-7.5 |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP AND 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.
