KimaCell®HPMC F50 Hydroxypropyl methyl cellulose is the most commonly used excipient in tablets and is often used as a filler for solid preparations. It has good compressibility, absorbs moisture without deliquescence, and swells with water, so it should not be used alone. It is often used in combination with powdered sugar or dextrin to increase the hardness of the tablet. Can be used as diluent, binder, disintegrant. The ethanol solution and aqueous solution of HPMC can improve the dissolution rate of the drug, which is mainly the result of the suspension and surface activity of HPMC, which reduces the surface tension between the solution and the solid drug, increases the wettability, and is beneficial to the drug. dissolution.
HPMC F50 ( 9004 65 3 ) Hydroxypropyl Methyl Cellulose (HPMC) | |
Physical Analysis | |
Appearance | White to slightly off-white fibrous or granular powder. |
Identification A to E | Conform |
Solution appearance | Conform |
Methoxy | 27.0-30.0% |
Hydroxypropoxy | 4.0-7.5% |
Loss on drying | 5.0% Max |
Residue on ignition | 1.5% Max |
pH | 5.0-8.0 |
Apparent viscosity | 40-60cps |
Particle size | Min. 98% pass through 100 mesh |
Heavy Metals | |
Heavy Metal | ≤10ppm |
Arsenic | ≤3ppm |
Lead | ≤3ppm |
Mercury | ≤1ppm |
Cadmium | ≤1ppm |
Micro bacteria | |
Total plate count | ≤1000cfu/g |
Yeast and Mould | ≤100cfu/g |
Coli form | Absent/g |
Salmonella | Absent/g |
KimaCell® HPMC F50 is a nonionic cellulose ether. Because of its excellent film-forming properties, adhesive properties, and colloid retention properties, it has been widely used in the pharmaceutical industry: adhesives for tablets or pills, film coating agents for tablets or pills; slow-release, controlled release materials; thickeners and dispersants for liquid preparations; dispersants for paste preparations; with the development of the world's pharmaceutical industry, especially the development of new pharmaceutical dosage forms, the quality requirements for pharmaceutical excipients are getting higher and higher, especially for The disintegration time of tablets, the control of dissolution index, the demand for medicinal cellulose ether is growing rapidly. In China, the dosage of medicinal hydroxypropyl methylcellulose is increasing at a rate of 15-20% every year, and have a good export prospect in the international market.