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PRODUCT INTRODUCTION:
HPMC is short for Hydroxypropyl Methylcellulose. The product is nonionic cellulose ether, white powder in appearance, odorless and tasteless. It is soluble in water and most polar organic solvents, and sells into transparent or slightly turbid colloidal solution in cold water. The aqueous solution possesses such characteristics as surface activity, high transparency and stable performance. It also owns the property of thermal gelling, thus its aqueous solution can form into glue to separate out after heating, and then it dissolve after cooling, with different gelling temperature in different specifications of products. The solubility changes with viscosity. The lower viscosity is the larger solubility is. The properties of HMPC of different specifications are different, while solution of HPMC in water will not be affected by PH value.
CHARACTERISTIC:
|
Common Name |
Hydroxypropyl Methylcellulose |
|
Abbreviation |
HPMC |
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CAS No |
9004-34-6 |
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Conforming Standard |
CP (Chinese Pharmacopoeia) |
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USP (United States Pharmacopoeia) |
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EP (European Pharmacopoeia) |
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JP (Japanese Pharmacopoeia) |
APPLICATION:
In oral preparation, HPMC is mainly applied as tablet adhesive, film coating material and framework material of sustained-release; in topical preparation, it is mainly applied as suspending agent and thickener of ophthalmology preparation, and also as emulsifier, suspensions and stabilizer of gel and ointment.
SPECIFICATION:
|
Item |
Specification |
||
|
60 |
65 |
75 |
|
|
Methoxy group (%) |
28.0-32.0 |
27.0-30.0 |
19.0-24.0 |
|
Hydroxypropyl group (%) |
7.0-12.0 |
4.0-7.5 |
4.0-12.0 |
|
Gelation temperature (℃) |
56-64 |
62.0-68.0 |
70.0-90.0 |
|
Viscosity (mpa·s) |
3,5,6,15,50,4000 |
504,000 |
100,400,015,000,100,000 |
|
Loss on drying (%) |
≤ 5.0 |
||
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Residue on ignition % |
≤ 1.5 |
||
|
pH |
4.0-8.0 |
||
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Heavy Metal |
≤ 20 |
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Arsenic (As) |
≤ 2.0 |
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Explanation:
1. The viscosity in USP is 80%-120% when the marked viscosity equals to or is lower than 100mpa•s, while 75%-140% when the marked viscosity exceeds 100mpa•s.
2. The viscosity in EP is 80%-120% when the marked viscosity is lower than 600mpa•s, while 75%-140% when the marked viscosity equals to or exceeds 600mpa•s.
PACKAGE:
Net weight 25kg, packed in fiber can lined with double layer polyethylene bad.
STORAGE AND TRANSPORTATION:
The product should be stored on the pallet, in a light-proof, well-closed, cool, dry and ventilated place (at a temperature of ≤23℃ and a relative humidity of ≤60%). Following the above guidelines should insure 12-month shelf life. After opening the original packing, the complete content should be used immediately. Material can be microbiologically contaminated from unhygienic environment. It is a non-dangerous product and can be transported as a common chemical product. Protect them from sunshine or rain. Must not be loaded and transported with toxic, hazard outstand polluting substances. Handle with care in order to avoid damaging the package.
QUALITY AND SAFETY ASSURANCE:
Controlled under certified quality system ISO and product safety is ensured by established safety system.
TEST METHOD: Full details and test method are available on request.