YH-MIP-0982 Transdermal Cream Particle Size and Crystal Form Analyzer

YH-MIP-0982 Transdermal Cream Particle Size and Crystal Form Analyzer：

As the particle size inspection method recommended in Section 0982 of Chinese Pharmacopoeia 2020, it is a sharp tool for inspecting samples of semi-solid preparations (plasters, ointments, gel, etc.), API API powder, solid powder, etc. The sample can be automatically subjected to particle size testing, while providing particle size, quantity, average particle size, D10/25/50/90 (adjustable), morphology, and related particle morphology parameters. The equipment consists of a microscope host (which can also be equipped with different types of microscopes), a high-resolution industrial camera, professional operation analysis software, and an operation computer.

YH-MIP-0982 Transdermal Cream Particle Size and Crystal Form AnalyzerEquipment technology advantages:
1. Equipped with an automatic sample preparation device, the operation is simple and the data is stable;
2. Manually select the area, and the area range can be selected for convenience and speed;
Automatic particle counting within 3 fields of view, with the ability to stack multiple fields of view, saving analysis time and reducing human operational errors;
4. Rich data presentation forms and data report templates to choose from;
5 compatible with black and white/color page mode, polarization mode, observe drug crystal form;
6 optional solid dispersion/semi-solid dispersion sample preparation devices;

YH-MIP-0982 Transdermal Cream Particle Size and Crystal Form AnalyzerIntroduction to device software functions:
1. Inspection range: 0.2 μ m-3000 μ m (with different lenses)
The software within the analysis area automatically performs data analysis, including quantity and size statistics, and can overlay data from multiple fields of view. The analysis area can be set;
Combining polarization mode, different types of particle sizes can be analyzed separately to distinguish between droplets/bubbles/API, while observing drug crystal forms;
4 Statistical data methods: Quantity diameter, volume diameter, area diameter
5 particle morphology parameters: long diameter, short diameter, circumference, area, shape ratio, and other parameters;
6 Report output parameters: D0-D100 range can be customized, particle analysis range can be set, and particle interval counting can be performed;
7. Data reports can be automatically set up according to settings, or particle statistical data can be exported in EXCEL for independent analysis;
8 automatic lighting monitoring, providing appropriate light intensity parameters, with black and white and color modes optional;
9 can be used for video recording and real-time monitoring of particle changes;
10 has data segmentation and merging functions to fit abnormal particles;
The 11 software complies with the data integrity requirements of 21CFR Part 11 and NMPA, including user permission management, audit trail, electronic records, electronic signatures, database backup and restoration, etc;
12. Configure standard line rulers and counting boards that have been measured, and verify the size and counting accuracy separately;
13 on-site installation, training, and 3Q certification completed;