| 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 | 300 – 500 | 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 |
Low-to-Medium Viscosity USP/EP Pharmacopoeia-Grade HPMC, ued for film formation, basic thickening, low-strength gel systems.
Celopre® ME400 is specifically designed for pharmaceutical film coating applications (tablet coating, taste masking, moisture protection, and aesthetic enhancement); its low-viscosity formulation ensures stable spraying and prevents nozzle clogging.
Celopre® ME400 serves as an aid for disintegration control, a binder, and a tableting aid; it is not intended for use as a primary component in controlled-release systems.
Celopre® ME400 serves as a mild thickener for lotions, a film-forming agent for face masks, a structural component for transparent gel systems, and a stabilizer to prevent phase separation. It imparts a lightweight texture and creates a natural-looking film.
