KimaCell®HPMC E50 Hydroxypropylmethylcellulose is a multi-purpose non-ionic cellulose derivative, mainly used as a solid preparation disintegration and binder, because the powder of the HPMC E50 has a large surface area and porosity, it can quickly absorb water and swell, and is used in tablets At the same time, the tablet disintegrates quickly, and its rough structure has a large inlay between the drug and the particles, which can significantly increase the hardness of the tablet without affecting the disintegration, thereby accelerating the dissolution rate of the drug and improving the bioavailability. The dosage of this product is generally about 2-5%. In tablet production, HPMC E50 can be used for internal addition in wet granulation, or it can be added externally or both internally and externally for better effect.
HPMC E50 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 | 28.0-30.0% |
Hydroxypropoxy | 7.0-12.0% |
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 E50 is a chemically inert substance, compatible with most active drugs and preparation excipients. HPMC E50 has following advantages in pharmaceutical excipients:
Reduce the difficulty and time of prescription screening
Increase the success rate of R&D and accelerate the launch of products
Meet the sustained release requirements of various solubility active drugs
very narrow viscosity range
Ensure the stability of drug release
Reduce batch-to-batch variation
Strict particle size control - 75μm (200 mesh)
Uniform particle size is conducive to the application of powder direct compression process, which is conducive to rapid hydration and gel layer formation
Reduce shipping time
Guaranteed timely supply
Meet the requirements of USP/EP/JP
Reduce the number of prescriptions
Shorten development time
Market acceptability
Prescriptions can be considered GMO/TSE/BSE free