Insoluble Particle Detection Scheme in Emulsions/Fat Emulsions - Microscopic Counting Method Insoluble Particle Analyzer Experimental Process

Case study explanation:

Emulsions are commonly used as drug carriers and have the advantages of sustained release, controlled release, and targeted localization for drugs. They have broad development prospects in anti-tumor, antimicrobial, and other fields. Currently, medicinal intravenous emulsions have become a popular research object in drug release systems.

Emulsions with different particle sizes generally exhibit different appearance forms. For O/W emulsions, when the particle size of the milk is large, the drug appears as a milky white cloudy appearance. The section of the United States Pharmacopeia<788>states that emulsions and other types of injections are not suitable for using the photoresist method to detect insoluble particles in samples, leading to the suggestion that microscopic methods should be used for insoluble particle detection.

Sample description: Milky white turbid liquid

Testing method analysis:

The testing principle of the photoresist method is that when laser is irradiated on a flow cell, particles passing through the flow cell will cause a light attenuation signal, which will be converted into electronic pulses, recorded, and related to the equivalent circle diameter of the particles. The optical impedance method can only measure particles that are opaque or have a refractive index significantly different from the surrounding liquid. When the sample appears milky white, abnormal refractive index can cause deviation in the test results. When using microscopy to detect such formulations, it can directly avoid erroneous results based on testing principles.

Testing process:

Sample preparation:Open the container bottle, pour it into the filtration device covered with a filter membrane, and perform filtration under low pressure. Place the obtained filter membrane in a petri dish and dry it at low temperature;

Testing:After drying, place the membrane under the lens of YH-MIP 0103 Microscopic Counting Insoluble Particle Analyzer, adjust the parameters, and conduct testing.

Notes:All work is carried out in a clean workbench.

Result Discussion:

During the testing process, due to the variability of emulsion particle shape, the emulsion particles will be filtered out after passing through the filter membrane, while insoluble particles will be retained on the filter membrane. Compared with using photoresist method for insoluble particle detection, using microscope method can effectively avoid emulsion particles being mistakenly identified as insoluble particles, thereby ensuring the accuracy of test data. From the test results of the sample, it can be seen that there are many small particles inside the sample. Although these particles of different sizes and quantities are not within the requirements of the insoluble particle standard for injections in the pharmacopoeia, the data report of these small particles can still provide some effective practical judgment standards for emulsion quality.

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.