Application of Microscopic Particle Size Analyzer in Particle Size Detection of Ointment Preparations

In the 2020 edition of the Chinese Pharmacopoeia "0109 Ointment and Cream", it is stated that particle size testing is a mandatory item for this type of preparation. The Pharmacopoeia also specifies how to conduct this test, and the first method (microscopic method) in the general rule "0982 Particle Size and Particle Size Distribution Determination Method" should be used for determination.

Sample description:Viscous paste like substance

Figure 1: Sample Physical Image

Sample preparation method:The sample is placed on a glass slide, diluted with an appropriate amount of glycerol, covered with another cover glass on top of the drug, gently pressed to ensure uniform particle distribution, and placed under the lens of YH-MIP 0103 insoluble particle analyzer for photography observation.

Testing process:Check the entire field of view of the cover glass at a magnification of 50-100 times, and there should be no condensation phenomenon. Particles larger than 50 microns should not be detected; Subsequently, the total number of particles and the specified size of particles in the field of view were detected at a magnification of 200-500, and the percentage of particles of different sizes was calculated using software.

Test results:

The test results consist of two parts: real images of particles and a summary analysis of the granularity analysis system structure. The real pictures of particles can intuitively understand the dispersion of particles, which can provide certain guidance for the process development of reagents; The summary analysis of the structure of the particle size analysis system provides information on the number of particles in different particle size ranges, D10, D50, D90, as well as maximum/minimum particle size and average diameter in the sample. By comparing the test results with historical data, the differences between samples from different batches can be obtained, which is beneficial for researchers to make judgments and distinctions.

Testing instrument: YH-MIP 0103 Microscopic Counting Insoluble Particle Analyzer

technical advantage

√ Automatic scanning of the entire filter membrane, simple operation, saving time;

√ Fully automatic particle counting, protecting the eyes and reducing human operation errors;

√ Compliant with pharmacopoeias/national standards and regulations of various countries, with one click automatic issuance of corresponding reports;

√ Comply with the requirements of 21CFR Part 11 and GMP for data integrity.