| Polyethylene glycol 400 USP-NF/Ph.Eur PARENTEX PLUS 2LT | |||
| I1216LC200 | 42258G807KW | ||
| USP-NF/Ph.Eur PARENTEX PLUS | 42258G8 | ||
| 25322-68-3 | 99289 | ||
| H(OCH2)nCH2OH | November 2023 | ||
| 380-420 | October 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Clear, colourless, slightly hygroscopic viscous liquid, having a slight characteristic odour, and a specific gravity at 25°C of 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, 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 mm2.s-1 | 94 - 116 mm2.s-1 |
| 12 | Dynamic Viscosity | 108 mPa.s | 105 - 130 mPa.s |
| 13 | Hydroxyl value | 286 | 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 | 0.1% | NMT 2.0% |
| 20 | Residue on ignition | 0.04% | NMT 0.1% |
| 21 | pH | 5.71 | 4.5-7.5 |
| 22 | Total aerobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml |
| 23 | Total Yeast & mold count | Less than 10 CFU/ml | NMT 10 CFU/ml |
| 24 | E.coli | Absent/ml | should be absent/ml |
| 25 | Staphylococcus aureus | Absent/ml | should be absent/ml |
| 26 | Pseud. aeruginosa | Absent/ml | should be absent/ml |
| 27 | Bile-tolerant gram negative bacteria | Absent/ml | should be absent/ml |
| 28 | Becterial endotoxins test | Less than 2.5 EU/ml | NMT 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.
