Pharmaceutical Grade – Medium-Low Viscosity, Low Substitution HPMC.
| 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 | % | 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® MF400 is a pharmaceutical-grade HPMC that strikes a balance between film-forming properties, structural integrity, and enhanced stability.
CELOPRE® MF400 is suitable for moisture-proofing, thicker film coatings, and coating systems requiring enhanced stability.
Its key features include the formation of a denser film structure that is less prone to tackiness, as well as superior environmental adaptability;
It prioritizes protection and stability over a lightweight aesthetic.
CELOPRE® MF400 is suitable for suspension and dispersion systems, and can be utilized for the stabilization of API suspensions, liquid formulations, and uniformity control.
Its key advantage lies in possessing sufficient viscosity to maintain stability without becoming excessively viscous, thereby facilitating ease of handling and uniform dispersion.
Compared to the lower-viscosity 40–60 grades, CELOPRE® MF400 is better suited for use as a tablet binder;
It can be reliably employed in wet granulation, as an aid in direct compression, and for enhancing tablet strength.
Its key advantage lies in providing superior binding efficiency and structural support for tablets, making it a more valuable choice for this specific application.
