INTRODUCTION

All products intended for parenteral administration must be visually inspected for the presence of particulate matter as specified in Injections and Implanted Drug Products 〈1〉. Dry solids, from which constituted solutions are prepared for injection, meet the requirements for Completeness and clarity of solutions in Injections and Implanted Drug Products 〈1〉 when they are prepared just before use. Where used in this chapter, the term essentially free means that when injectable drug products are inspected as described herein, no more than the specified number of units may be observed to contain visible particulates. Particulate matter is defined in Particulate Matter in Injections 〈788〉 as extraneous mobile undissolved particles, other than gas bubbles, unintentionally present in solutions. See Subvisible Particulate Matter in Therapeutic Protein Injections 〈787〉 for additional information on inherent, intrinsic, and extrinsic particulates. Examples of such particulate matter include, but are not limited to, fibers, glass, metal, elastomeric materials, and precipitates. However, some products may contain inherent particles or agglomerates; in such cases, requirements for these particular visible particulates are specified in the individual monograph or in the approved regulatory application but the control and acceptance criteria for extraneous particles described in this chapter apply.