Injectables-related USP Documentary Standards

Provided below are the USP Documentary Standards related to therapies administered either subcutaneously or by intravenous infusion published in the United States Pharmacopeia-National Formulary (USP–NF).

USP-NF Documentary Standard

<1> Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
<61> Microbial Enumeration Tests
<71> Sterility Tests
<85> Bacterial Endotoxins Test
<221> Chloride and Sulfate
<281> Residue on Ignition
<381> Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems
<643> Total Organic Carbon
<645> Water Conductivity
<697> Container Content for Injections
<729> Globule Size Distribution in Lipid Injectable Emulsions
<787> Subvisible Particulate Matter in Therapeutic Protein Injections
<788> Particulate Matter in Injections
<790> Visible Particulates in Injections
<791> pH
<921> Water Determination
<1231> Water for Pharmaceutical Purposes
<1381> Assessment of Elastomeric Component Used in Injectable Pharmaceutical Product Packaging/Delivery Systems
<1787> Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
<1790> Visual Inspection of Injections