CELOPRE® LS11 is a USP/NF pharmacopoeia-grade HPMC (K series) with low methoxy and high hydroxypropoxy content, mainly used in sustained-release tablets and controlled-release systems, where drug release is controlled by forming a gel layer.
| Test Item | Unit | Specification | Method |
|---|---|---|---|
| Appearance | White to Yellowish white | Visual | |
| Identification A | Conforms | USP30 NF25 | |
| Identification B | Conforms | USP30 NF25 | |
| Identification C | Conforms | USP30 NF25 | |
| pH | 5.0-7.5 | USP30 NF25 | |
| Loss on drying | % | 5.0 Max | USP30 NF25 |
| Residue on ignition | % | 0.5 Max | USP30 NF25 |
| Chloride | % | Not more than 0.36 | USP30 NF25 |
| Heavy metals | % | Not more than 0.001 | USP30 NF25 |
| Hydroxypropoxyl Content | % | 10.0 – 12.9 | USP30 NF25 |
| Particle size: Retain on 180m | Micro | <0.5% | |
| Pass through 150m | Micron | >98% |
CELOPRE® LS11 can be used to both sustained-release and controlled-release formulations, to control drug release rate by forming a gel barrier.
CELOPRE® LS11 is used as a matrix material for hydrophilic matrix tablets, featuring stable release and adjustable release profiles.
CELOPRE® LS11 is applicable to both wet granulation and direct compression, and offers stronger structural strength compared to the E series.
