| Test Item | Unit | Specification | Standard |
|---|---|---|---|
| Characters | Conforms | EP/USP NF | |
| Identification A | Conforms | EP/USP NF | |
| Identification B | Conforms | EP/USP NF | |
| Identification C | Conforms | EP/USP NF | |
| Identification D | Conforms | EP/USP NF | |
| Identification E | Conforms | EP/USP NF | |
| Identification F | Conforms | EP/USP NF | |
| pH | 5.5-8.0 | EP/USP NF | |
| Apparent Viscosity | mPa.s | 13,000 – 17,000 | EP/USP NF |
| Appearance of Solution | Conforms | EP/USP NF | |
| Chlorides | % | Max 0.5 | EP/USP NF |
| Loss on drying | % | 5.0 Max | EP/USP NF |
| Residue on ignition | % | 1.0 Max | EP/USP NF |
| Heavy metals | % | Not more than 0.001 | EP/USP NF |
| Methoxyl Content | % | 19.0 – 24.0 | |
| Hydroxypropoxyl content | % | 4.0 – 12.0 | |
| Total Microbial Count | cfu/g | Max 1000 | |
| Total Mould and Yeast | cfu/g | Max 100 | |
| E.Coli | Negative |
Pharmaceutical / Food Excipient Grade, Medium-to-High Viscosity HPMC (approx. 15,000 mPa·s)
Key Features:
✔ Compliant with EP / USP-NF (Suitable for use in pharmaceutical and food systems)
✔ Viscosity: 13,000–17,000 mPa·s (Characterized by structural viscosity rather than low-viscosity flow properties)
✔ Methoxyl + Hydroxypropoxyl Content: Within the standard pharmaceutical range
✔ Microbiological Purity: TAMC ≤ 1000 CFU/g, Molds ≤ 100 CFU/g (Suitable for use in oral dosage forms)
Celopre® MK15M is effectively serves as a foundational film for controlled-release and sustained-release formulations, significantly enhancing the visual appearance of tablets while providing reliable moisture protection for Active Pharmaceutical Ingredients (APIs), thereby comprehensively improving tablet quality and stability.
Celopre® MK15M is suitable for the production of plant-based capsules (vegetarian capsules); it serves as a substitute for gelatin, providing structural support while meeting standard performance requirements.
