This chapter is related to the European Pharmacopoeia and/Or consistent with the corresponding text in the Japanese Pharmacopoeia. These pharmacopoeias have promised not to make any unilateral modifications to this coordination chapter. This general chapter text belongs to the countryUSPPart of the text, therefore not part of the coordinated text, marked with symbols(◆◆)Provide a specific explanation of this fact.

The particles in injections and non injections are composed of foreign, movable, and undissolved particles (excluding bubbles) that accidentally exist in the solution.

◆As chapter<1> Injections and Implanted Drug ProductsAs stated in the document, injection solutions administered through muscle or subcutaneous routes must meet the following requirements<788> Particulate Matter in InjectionsChapter requirements. This requirement has been indefinitely postponed for veterinary products. Specially packaged and labeled solutions for parenteral flushing are not affected<788>Limitations on particulate matter requirements. Radioactive drug preparations are not affected<788> Particulate Matter in InjectionsLimitations of Chapters. Non intestinal products that require the use of a final filter before medication as specified on the label are exempt from this requirement<788> Particulate Matter in InjectionsThe restriction is based on scientific data proving that this exemption is reasonable.◆

For the determination of particulate matter, two methods are specified below, namely method1(Particle counting test using photoresist method) and method2(Microscopic particle counting test). When checking for the presence of sub visible particles in injections and parenteral infusions, it is best to use this method1However, it may be necessary to test certain formulations through photoresist particle counting tests and microscopic particle counting tests to obtain satisfactory conclusions.

Not all parenteral preparations can detect sub visible particles through one or both of the above methods. For example, if the transparency of the formulation decreases or the viscosity increases, the method1When not applicable, the method should be followed2Conduct experiments. Emulsions, colloids, and liposomes are examples. Similarly, products that generate air or bubbles when inhaled into sensors may also require microscopic particle counting testing. If the viscosity of the test preparation is high enough to be checked by any test method, it is necessary to use appropriate diluents for quantitative dilution if necessary to reduce the viscosity for analysis.

The results obtained when inspecting individual units or groups of particles cannot be extrapolated to other untested units with certainty. Therefore, if effective inferences are to be drawn from observational data to characterize the levels of particulate matter in a large number of units, a statistically reasonable sampling plan must be developed.

◆For the purpose of this chapter, small volume parenteral injection is synonymous with small volume injection, while large volume parenteral injection is synonymous with large volume injection.◆