How to perform insoluble particle detection on suspension type injections, Yinhuang Technology will take you to see together!

Case study explanation:

Suspension type injections are generally used for intramuscular injection, which are usually water-insoluble drugs or drugs that require prolonged efficacy after injection. After forming a suspension, they present an opaque appearance.

The section of the United States Pharmacopeia<1788>states that when the sample presents a milky white morphology, it is not suitable to use the photoresist method for insoluble particle detection. In this case, the microscopic method 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. At this point, using microscopic counting method to detect such preparations 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:

This test has added a threshold in parameter design, and the purpose of creating a new reference standard is to focus on particles of 2 microns and above, and 5 microns and above in the sample. These small-sized particle information have a significant impact on the drug expression of the sample. From the test results of the sample, it can be seen that unexpected fibers appeared inside the sample, indicating that there may have been improper attire by operators during the production process of the reagent, which needs to be rectified.

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.