The presence of visible foreign matter particles in a drug affects the quality of the drug solution, the filing and marketing of the product, and the efficacy and safety of the drug. CD Formulation helps clients test the quality of their drugs through visible foreign matter testing, while rejecting non-compliant products.
Visible foreign matter refers to insoluble substances, usually larger than 50 μm in size or length, that can be visually observed in injectables, ophthalmic liquid formulations and sterile APIs under specified conditions.
Visible foreign matter inspection method has lamp inspection method and light scattering method. The introduction of visible foreign matter should be avoided during laboratory testing. When the preparation of sterile powder for injection and sterile API test solution, or the test container is not suitable for inspection, need to be transferred to a suitable container, should be conducted in a clean environment at the B level.
According to the requirements of various types of test products, take the required amount of test products, remove the container label, wipe the outer wall of the container, if necessary, the drug solution will be transferred to a clean and transparent suitable container, the test products placed at the edge of the shade, in the bright vision distance, holding the neck of the container, gently rotate and flip the container, so that the possible presence of visible foreign substances in the drug solution suspended, respectively, under the black and white background visual inspection, repeat the observation, the total inspection time limit of 20 seconds. When a large number of bubbles in the test solution affects the observation, it should be left for a sufficient time until the bubbles disappear and then checked.
When a monochromatic laser irradiates the solution, the insoluble material in the solution scatters the incident light, and the scattered energy is related to the size of the insoluble material. This method checks the visible foreign matter by measuring the light scattering energy caused by the insoluble substance in the solution and comparing it with the specified threshold value.
After the test specimen is placed into the detection device, the spinning bottle device makes the test specimen rotate at high speed along the vertical central axis for a certain time and then stops rapidly, while the uniform laser beam from the laser light source irradiates on the test specimen; when the vortex of the drug solution basically disappears and the drug solution inside the bottle continues to rotate due to inertia, the image collector continuously cameras the scattered light energy caused by the insoluble substances suspended in the rotating drug solution at a specific angle; the data processing system processes the collected sequence images and then automatically determines the presence or absence of insoluble substances exceeding a certain size according to the pre-set threshold, or displays the images on the terminal monitor for manual determination, while recording the test results.
The types of drugs to be tested include: biological products (injection, eye drops), non-biological products.
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