Pharmaceutical grade POVAL [PE Series]
Pharmaceutical grade POVAL is polyvinyl alcohol (PVA) that can be used for pharmaceutical excipients.
The PVA is produced using our manufacturing control and quality control, which are compliant with the Internal- Initiative GMP standards guideline of the Japan Pharmaceutical Excipients Council (JPEC). The PVA is best suited for ingredients in cosmetics and pharmaceutical products.
Grade and Quality Specifications
| Analysis | PE-05JPS |
| Degree of Hydrolysis (mol%) | 85-89 |
| 4% Viscosity (mPa•s) | 4.6-6.0 |
| Notes | Fine powder (150μm or less) |
| Compliant with JPE, USP, and EP* articles |
*Compendial
| Compendial | Listed name |
| Japanese Pharmaceutical Excipients (JPE) | Polyvinyl alcohol (fully hydrolyzed) |
| Polyvinyl alcohol (partially hydrolyzed) | |
| United States Pharmacopeia (USP) | Polyvinyl alcohol |
| European Pharmacopoeia (EP) | Poly（vinyl alcohol） |
As listed in compendials in Japan, the US and Europe, polyvinyl alcohol (PVA) is compliant with the requirements of each compendial and suited for ingredients in pharmaceutical products.
Features
- Grinding, homogenizing and packaging of PE series are executed in new facilities that are compliant with the Internal- Initiative Pharmaceutial Excipient GMP standards guidelines on hardware.
- PE series are produced under the procedures that are compliant with the Internal- Initiative Pharmaceutial Excipient GMP standards guidelines on software.
- Certificate of Analysis issued complies with the Japanese Pharmaceutical Excipients (JPE), the United States Pharmacopeia (USP), and the European Pharmacopoeia (EP) , endorsing that the analyzed values are compliant with the requirements of each compendial.
- The product is provided in a 20kg kraft paper bag with a polyethylene inner bag. As the inner bag and the outer bag are heat-sealed, there are no threads to get mixed in the product. The outer bag can be easily opened with tear tape, so the inner bag can be pulled out.
Characteristics and Applications of PVA
| Characteristics | Applications | |||
| Film coating for tablets | Binder for granulation | Capsules | Gel patches | |
| Water solubility | ||||
| Film property | ||||
| Binding ability | ||||
| Gas barrier (oxygen and moisture) |
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