HPMC E6
Kima chemical®HPMC E6 Hydroxypropyl methylcellulose is a non-ionic cellulose mixed ether made from cotton and wood through alkalization, propylene oxide and methyl chloride etherification. It is odorless, tasteless, non-toxic, soluble in cold water and gelled in hot water. Hydroxypropyl methylcellulose is a cellulose mixed ether variety whose production, dosage and quality have been rapidly increasing in China in the past 15 years. It is also one of the most widely used pharmaceutical excipients at home and abroad.
Specification of HPMC E6
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HPMC E6 |
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Hydroxypropyl Methyl Cellulose (HPMC) |
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Physical Analysis |
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Appearance |
White to slightly off-white fibrous or granular powder. |
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Identification A to E |
Conform |
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Solution appearance |
Conform |
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Methoxy |
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Hydroxypropoxy |
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Loss on drying |
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Residue on ignition |
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pH |
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Apparent viscosity |
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Particle size |
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Heavy Metals |
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Heavy Metal |
≤10ppm |
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Arsenic |
≤3ppm |
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Lead |
≤3ppm |
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Mercury |
≤1ppm |
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Cadmium |
≤1ppm |
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Micro bacteria |
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Total plate count |
≤1000cfu/g |
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Yeast and Mould |
≤100cfu/g |
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Coli form |
Absent/g |
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Salmonella |
Absent/g |
Application of HPMC E6
KimaCell® HPMC E6 is widely used in pharmaceutical excipients. The application of HPMC is mainly reflected in the following five aspects:
As a suspending agent.
Suspension-type liquid preparation is a commonly used clinical dosage form, which is a heterogeneous dispersion system in which insoluble solid drugs are dispersed in a liquid dispersion medium. The stability of the system determines the quality of the suspension liquid preparation. HPMC colloidal solution can reduce the solid-liquid interfacial tension, reduce the surface free energy of solid particles, and stabilize the heterogeneous dispersion system. It is an excellent suspending agent. HPMC is used as a thickener for eye drops, with a content of 0.45% to 1.0%.
As a binder and disintegrant.
As a binder, HPMC can make the drug easy to wet, and it can expand hundreds of times after absorbing water, so it can significantly improve the dissolution rate or release rate of the tablet. HPMC has strong viscosity, which can enhance the particle viscosity and improve the compressibility of raw materials with crisp or brittle texture. HPMC with low viscosity can be used as binder and disintegrant, and those with high viscosity can only be used as binder.
As a sustained and controlled release material for oral preparations.
HPMC is a commonly used hydrogel matrix material in sustained-release preparations. Low viscosity grade (5-50mPa·s) HPMC can be used as binder, viscosifier and suspending agent, and high-viscosity grade mPa·s) HPMC can be used to prepare mixed material matrix sustained-release tablets, Blocking agent for capsules, hydrogel matrix extended-release tablets. HPMC is soluble in gastrointestinal fluid, has the advantages of good compressibility, good fluidity, strong drug loading capacity, and drug release characteristics not affected by pH. It is an extremely important hydrophilic carrier material in sustained-release preparation systems and is often used as Hydrophilic gel matrix and coating materials for sustained-release preparations, as well as auxiliary materials for gastric floating preparations and sustained-release drug film preparations.
As a coating film-forming agent.
HPMC has good film-forming properties. The film formed by it is uniform, transparent and tough, and it is not easy to stick during production. Especially for drugs that are easy to absorb moisture and are unstable, using it as an isolation layer can greatly improve the stability of the drug and prevent The film changes color. HPMC has a variety of viscosity specifications. If selected properly, the quality and appearance of coated tablets are superior to other materials. The commonly used concentration is 2% to 10%.
As capsule material.
In recent years, with the frequent outbreaks of global animal epidemics, compared with gelatin capsules, vegetable capsules have become the new darling of the pharmaceutical and food industries. Pfizer of the United States has successfully extracted HPMC from natural plants and prepared VcapTM vegetable capsules. Compared with traditional gelatin hollow capsules, vegetable capsules have the advantages of wide adaptability, no risk of cross-linking reactions and high stability. The drug release rate is relatively stable, and individual differences are small. After disintegration in the human body, it is not absorbed and can be excreted The substance is excreted from the body. In terms of storage conditions, after a large number of tests, it is almost not brittle under low humidity conditions, and the properties of the capsule shell are still stable under high humidity conditions, and the indicators of plant capsules are not affected under extreme storage conditions. With people's understanding of plant capsules and the transformation of public medicine concepts at home and abroad, the market demand for plant capsules will grow rapidly.
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