Certificate of Analysis and technical specification for Polyethylene Glycol 400 — CAS 25322-68-3. Applies to all consignments of this product and grade.
| Product Name | Polyethylene Glycol 400 |
|---|---|
| C.A.S. Number | 25322-68-3 |
| Product Category | Pharmaceutical Excipients |
| Product Group | Plasticizers & Solvents |
| Grade / Standard | IP/BP/USP/EP |
| Physical Form | Colourless viscous liquid |
| Country of Origin | India |
| Packing | Standard export packing — bags, drums, carboys, IBC or ISO tank as applicable |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
| S. No. | Test Parameter | Specification | Typical Result | Method |
|---|---|---|---|---|
| 1 | Description | Colourless viscous liquid | Complies | Visual |
| 2 | Identification (A) — Infrared absorption | Concordant with reference spectrum | Complies | IR Spectrophotometry |
| 3 | Identification (B) — Chemical / chromatographic | Positive for the substance | Complies | As per monograph |
| 4 | Assay (on dried basis) | 98.0 – 102.0 % w/w | 100.05 | HPLC / Titrimetry (Monograph) |
| 5 | Purity (by GC) | Not less than 99.5 % (area) | 99.93 | Gas Chromatography |
| 6 | Colour (APHA / Pt-Co) | Not more than 10 | 2 | ASTM D1209 |
| 7 | Water Content | Not more than 0.05 % w/w | 0.0085 | Karl Fischer titration |
| 8 | Acidity (as acetic acid) | Not more than 0.002 % w/w | 0.0007 | Titrimetry |
| 9 | Residue on Evaporation | Not more than 0.001 % w/w | 0.0001 | Gravimetry |
| 10 | Specific Gravity at 25 °C | 1.125 – 1.131 | 1.1285 | Pycnometry / ASTM D4052 |
| 11 | Refractive Index at 20 °C | 1.4650 – 1.4690 | 1.4668 | Refractometry / ASTM D1218 |
| 12 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.016 | Gravimetry (Monograph) |
| 13 | Heavy Metals | Not more than 20 ppm | Less than 10 ppm | ICP-OES / Limit test |
| 14 | Related Substances — any individual impurity | Not more than 0.10 % | 0.045 | HPLC |
| 15 | Related Substances — total impurities | Not more than 0.50 % | 0.133 | HPLC |
| 16 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
| 17 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 55 cfu/g | IP / USP <61> |
| 18 | Total Yeast & Mould Count | Not more than 100 cfu/g | 6 cfu/g | IP / USP <61> |
| 19 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 20 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
This document sets out the standard specification for Polyethylene Glycol 400 and applies to all consignments of this grade. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we will confirm compliance before order.
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