In the pharmaceutical industry, the cleanliness (insoluble particles) of intravenous injection drugs and injection water can be determined through the detection of liquid particle counters, ensuring quality and safety.

Overview of insoluble particles

Insoluble particles refer to flowable, randomly present tiny particles in intravenous injection drugs that are insoluble in water. Insoluble particles are foreign substances with a particle size generally ranging from 2 to 50μm, which are difficult to be seen by the naked eye. When their particle size exceeds a certain limit or their quantity exceeds a certain limit, they cannot be metabolized in the body and will cause some harm to the human body, such as the formation of granulomas, local tissue embolism and necrosis, phlebitis, tumors or tumor-like reactions. In severe cases, it can even cause allergic reactions and endanger life. Therefore, it is necessary to examine it and strictly control it.

Insoluble particle standard

The Pharmacopoeia of the People's Republic of China has clearly stipulated the limit of insoluble particles for intravenous injections:

For intravenous solutions with a labeled volume of 100 ml or more, unless otherwise specified, the number of particles larger than 10μm in each 1mL shall not exceed 25, and the number of particles larger than 25μm shall not exceed 3.

For intravenous solutions with a labeled volume of less than 100mL, sterile powders for intravenous solutions and concentrated solutions for injection, unless otherwise specified, the number of particles larger than 10μm in each test sample container shall not exceed 6,000, and the number of particles larger than 25μm shall not exceed 600.

Liquid particle counter

The Bebur BT8200 liquid particle counter can simultaneously monitor the particle size and corresponding quantity of 8 channels. It adopts the principle of light blockage method and can measure particles with a particle size range of 2-750um. It can detect the particle size and quantity in intravenous injections, ensuring the safety of intravenous medication.