| 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 | 40.0 – 60.0 | 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 | % | 27.0 – 30.0 | USP |
| Hydroxypropoxyl Content | % | 4.0 – 7.5 | USP |
| Total Microbial Count | cfu/g | Max 1000 | |
| Total Mould and Yeast | cfu/g | Max 100 | |
| E.Coli | Negative |
CELOPRE® MF50 is a low-hydroxypropoxy grade of HPMC (Grade E3), characterized by reduced hydrophilicity, a relatively slower dissolution rate, an elevated thermal gelation temperature, and film-forming properties that tend to be brittle and rigid.
CELOPRE® MF50 is specifically designed to meet the protective requirements of pharmaceutical film coatings; it is particularly well-suited for moisture-barrier coatings, high-strength coatings, and coating layers requiring environmental stability.
Compared to high-hydroxypropoxy versions, it forms a denser film with superior moisture resistance, prioritizing protective functionality over mere aesthetic enhancement.
CELOPRE® MF50 is particularly well-suited for tablet formation, serving as a binder for both dry and wet granulation processes, as well as a structural aid for tablets.
Its key advantage lies in its low hydroxypropoxy content; this structural feature presents stronger intermolecular forces and slightly enhanced structural integrity, thereby contributing to improved tablet formability.
CELOPRE® MF50 is suitable for use in cosmetic formulations—specifically styling and oil-control products.
It forms a dry film with a slightly firm tactile feel; while not as smooth as the high-hydroxypropoxy version, it is ideally suited for applications where a non-sticky finish, oil control, or styling performance is desired.
