USP/EP Pharmacopoeia Grade HPMC + High Viscosity (3000–5000 mPa·s) + Low Hydroxypropyl Substitution (4.0–7.5%).
| 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 | % | 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 |
High-viscosity, low-substituted pharmaceutical-grade HPMC forms a controlled-release system characterized by slower release, greater stability, and resistance to disintegration.
CELOPRE® MF4M can be used to including sustained-release tablets and controlled-release matrix tablets.
Its mechanism of action involves absorbing water and swelling to form a gel layer, thereby controlling the diffusion rate and release profile of the Active Pharmaceutical Ingredient (API) to achieve a steady release of the drug.
CELOPRE® MF4M can be used to tablets with high drug loads, highly soluble APIs (prone to burst release), and applications requiring prolonged release over 12 or 24 hours.
Its key advantage lies in its ability to effectively control the release rate by forming a stable gel layer, thereby preventing drug dumping and achieving a smooth, sustained-release profile.
CELOPRE® MF4M can be used to including hydrophilic gel-matrix tablets, bilayer tablets, and complex controlled-release structures.
Its key advantage lies in its ability to absorb water and form a stable gel-matrix layer, thereby enabling precise control over the drug release rate; it is particularly well-suited for multilayer and irregularly shaped controlled-release designs.
