| Test Item | Unit | Specification | Standard |
|---|---|---|---|
| Appearance | White to Yellowish white | Visual | |
| Characters | Conforms | EP | |
| Identification A | Conforms | EP/USP | |
| Identification B | Conforms | EP/USP | |
| Identification C | Conforms | EP/USP | |
| Identification D | Conforms | EP | |
| Identification E | Conforms | EP | |
| Identification F | Conforms | EP | |
| pH | 5.5-8.0 | EP/USP | |
| Apparent Viscosity | mPa.s | 3,000 – 5,000 | EP/USP |
| Appearance of Solution | Conforms | EP | |
| Chlorides | % | Max 0.5 | EP |
| Loss on Drying | % | 5.0 Max | EP/USP |
| Residue on Ignition | % | 1.0/1.5 Max | EP/USP |
| Heavy Metals | % | Not more than 0.001 | EP/USP |
| Arsenic | ppm | 3.0 Max | USP |
| Methoxyl Content | % | 28.0 – 30.0 | USP |
| Hydroxypropoxyl Content | % | 7.5 – 12.0 | USP |
| Total Microbial Count | cfu/g | Max 1000 | |
| Total Mould and Yeast | cfu/g | Max 100 | |
| E.Coli | Negative |
Pharmaceutical excipient grade HPMC (tablet / capsule / controlled release grade).
Celopre® ME4M is suitable for use in tablet systems as a direct compression binder, a sustained-release matrix material, and a film-coating agent; it represents the typical viscosity grade selected for sustained-release (SR/CR) tablets and controlled-release matrix systems.
Celopre® ME4M serves as a film-forming agent for face masks, a thickening and stabilizing agent for emulsions, a structural agent for gel systems, and an anti-settling stabilizer, thereby meeting a wide range of formulation requirements.
Celopre® ME4M can be applied to studies involving controlled-release models, granulation processes, and viscosity modulation systems, thereby meeting the diverse formulation exploration needs typical of the laboratory research phase.
