PH EUR 2.9.2 Test for Separation of Filtilla and Pessaries

EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and rapid testing services within the scope of the PH EUR 2.9.2 test. This standard determines whether suppositories or pessaries soften or disintegrate within the specified time when placed in a liquid medium in experimental conditions.

Fragmentation is considered to be achieved when:

• When dissolution is complete,
• The suppository or pessary components are separated: molten oily substances are collected on the surface of the liquid, insoluble powders fall to the bottom, and soluble components dissolve depending on the situation. type of preparation, components can be distributed in one or more of these ways,
• If there is softening in the sample, which may be accompanied by a noticeable deformation without complete separation of the components, the softening, wick or pessary no longer has a solid core that resists the pressure of a glass rod;
• The rupture of the gelatin shell of rectal or vaginal capsules occurs to allow release of the contents,
• If no residue or residue remains on the perforated disc, it consists only of a soft or foamy mass without a solid core and resists pressure.

It consists of a sleeve of suitable thickness of glass or of suitable clear plastic, a metal device attached to its interior by means of three hooks, each consisting of two perforated stainless metal discs. 4 holes with a diameter of 39 mm; the diameter of the discs is similar to the inner diameter of the sleeve; There is a distance of approximately 30 mm between the discs.

The test is performed using three such apparatuses, each containing a single sample. Each apparatus is placed in a beaker with a capacity of at least 4 liters filled with water.

Use the apparatus described above arranged to rest on the hooks. Place in a beaker of suitable diameter containing water held at 36-37°C with the level just below the upper perforated disc. Using a pipette, adjust the level with water at 36-37 °C until a uniform film covers the holes of the disc. Use three vaginal tablets. Place each on the top plate of one apparatus and cover the second with a glass plate to maintain proper humidity conditions. Examine the condition of the samples after the time specified in the monograph. All samples must be fragmented to pass the test.

EUROLAB assists manufacturers with PH EUR 2.9.2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.