Chinese Pharmacopoeia 0982 Particle Size Detection Method - Microscopic Method for Particle Size Analysis

The 2020 edition of the Chinese Pharmacopoeia 0982 particle size and particle size distribution determination method is used to determine the particle size or particle size distribution of active pharmaceutical ingredients and drug formulations. The microscope method and sieving method are used to determine the particle size or limit of pharmaceutical preparations, while the light scattering method is used to determine the particle size distribution of raw materials or pharmaceutical preparations.
The particle size in microscopy is represented by the length observed under the microscope. Firstly, calibrate the eyepiece micrometer.
In Chinese Pharmacopoeia 0109 Ointment Cream, ointment refers to a uniform semi-solid external preparation made by mixing raw materials with oil-based or water-soluble matrices. Cream refers to a homogeneous semi-solid preparation formed by dissolving or dispersing the raw material drug in an emulsion matrix. Unless otherwise specified, the particle size of ointments and creams should be tested according to the particle size and particle size distribution determination method (General Rule 0982 Microscopic Method).

The external preparation particle size analyzer ZML310 is an instrument suitable for particle size detection of external preparations. It can detect APIs, creams, ointments, gel, solid powders, etc. According to the 0982 particle size detection method microscope method, it is an instrument that is higher than this standard. The testing method refers to the 0982 particle size detection method - microscope method testing method, but it is simpler and does not require dilution of the sample. The sample is directly applied to a glass slide, and the cover glass is examined under a microscope. With the help of software, particles under the field of view are captured. You can directly provide the particle size distribution and particle shape distribution.

The advantages of the ZML310 external preparation particle size analyzer are:

1. The report is intuitive and provides direct information on particle size distribution and shape distribution;

2. Automatically identify and analyze particles in the field of view, and perform particle counting;

3. Directly provide parameters such as D10, D50, D90 in the report;

4. It is possible to analyze the particle size, shape, and quantity of polarized particles under polarization;

5. The reporting mode includes equivalent volume, equivalent area, particles, etc., which can be compared with laser particle size analyzer data;

6. The report can provide the volume percentage corresponding to the particle size;