Price of Beijing drug strong light stability test box

Price of Beijing drug strong light stability test boxIntroduction

The test sample is placed in a light box or other suitable lighting device equipped with a fluorescent lamp, with an illumination of4500lx±500lxUnder the condition of being placed for 10 days, samples were taken on the 5th and 10th days, and tested according to the stability key inspection items, paying special attention to the appearance changes of the test sample. Regarding the lighting device, it is recommended to use a standardized equipment "adjustable lighting box" or a light cabinet, and install several fluorescent lamps in the box to achieve the specified illumination. The height of the test bench in the box can be adjusted, and an exhaust fan is installed above the box to eliminate the heat generated by the light source. The box is equipped with an illuminance meter to monitor the illuminance inside the box at any time. The lighting box should not be affected by natural light and maintain a constant illuminance. At the same time, it is necessary to prevent dust from entering the lighting box.

Price of Beijing drug strong light stability test boxBasic requirements

(1) Stability tests include acceleration tests and * tests. Accelerated testing and * testing require three batches of test samples to be used.

(2) The test sample for traditional Chinese medicine preparations should be a product for scale-up testing, and its prescription and process should be consistent with large-scale production. The scale of each batch of scale-up experiments should be around 10000g or 10000 pills for pills, around 10000 tablets for tablets, and around 10000 capsules for capsules. For large volume packaged preparations (such as intravenous infusion, oral liquid, etc.), the quantity of each batch of scale-up experiments should be at least 10 times the total amount required for each experiment. The required quantity for special varieties and special dosage forms can be flexibly controlled according to the situation.

(3) The quality standards of the test samples should be consistent with the quality standards of the test samples used in various basic research and clinical validation.

(4) The containers, packaging materials, and packaging methods of the test samples used for accelerated testing and * testing should be consistent with those of the marketed products *.

(5) To study the stability of traditional Chinese medicine, specialized, accurate, precise, and sensitive analytical methods should be used and validated to ensure the reliability of the stability test results. In stability testing, attention should be paid to the inspection of degradation products.

(6) Due to the smaller quantity required for scale-up testing compared to large-scale production, the applicant should still conduct accelerated testing and stability testing on the three batches of mass-produced products that have passed production validation before transitioning from scale-up testing to large-scale production after obtaining approval.