USP/EP Pharmacopoeia Grade HPMC + Ultra-High Viscosity (25,000–35,000 mPa·s) + High Hydroxypropyl Substitution (7.5–12%).
| 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 | 25,000‐35,000 | 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 |
CELOPRE® ME30M is high-viscosity, pharmaceutical-grade HPMC for controlled-release Systems which can form a stable, robust, and sustained gel barrier, enabling prolonged and smooth drug release.
CELOPRE® ME30M is primarily utilized in sustained-release and controlled-release tablets—typically for 12-hour sustained-release, 24-hour controlled-release, and once-daily dosage forms.
It is particularly well-suited for APIs with moderate to low solubility, as well as for formulations requiring a smooth release profile to prevent fluctuations in blood drug concentration, thereby ensuring sustained and stable therapeutic efficacy.
CELOPRE® ME30M is utilized in high-viscosity matrix tablets; by constructing a hydrophilic gel matrix, it controls the diffusion pathway of the API, effectively prevents initial burst release, and achieves smooth, controlled drug release.
CELOPRE® ME30M is suitable for bilayer tablets (immediate-release + sustained-release), stepped-release (multiphasic release) formulations, and fixed-dose combination products.
Its key advantage is construction of a stable hydrophilic gel matrix, which enables the precise regulation of different drugs or release phases, thereby meeting the requirements for customized drug release profiles.
