Biocompatibility isn’t a box to check; it’s a continuous thread that runs from early material selection through commercial release. USP <87> Biological Reactivity Tests—In Vitro provide a fast, ethical, and sensitive cytotoxicity screen for materials and finished plastics/elastomers, helping teams make confident decisions both during characterization (often prior to, or in lieu of, in vivo testing and/or extractables & leachables (E&L) studies) and later as a release test. At CS Analytical, we execute USP <87> aligned methods and help you map results into the broader packaging qualification strategy.

What USP <87> Evaluates (In Plain Terms)

USP <87> assesses whether a material (or its extract) shows cytotoxic effects on mammalian cell cultures under controlled conditions (e.g., direct contact, agar diffusion, or elution). Results are graded for reactivity, with system-suitability controls ensuring data integrity. This makes <87> an ideal screen to quickly flag risky chemistries or residues before you invest in longer, more complex programs.

Where USP <87> Fits in Your Package/Component Strategy

Depending on your dosage form and component, USP <87> is referenced, directly or by practice, across multiple USP chapters governing plastics and elastomers. CS Analytical’s recommended applications include:

  • During characterization (pre-E&L / pre-in vivo):
    Use <87> to screen candidate resins, compounding variations, process changes, and finished components (stoppers, plungers, tips, bottles, blisters, etc.). This can reduce animal testing and sharpen the focus of subsequent USP <1663>/<1664> E&L work.
  • As a complementary/release test:
    After materials and package systems are locked, <87> can be applied as a periodic release or change-control check—particularly for elastomeric components qualified under USP <381> and guided by USP <1381> (and, functionally, USP <382> for performance where applicable).

How Specific Chapters Point You to USP <87>

  • Elastomers — USP <381> & USP <1381>:
    <381> sets baseline chemical and biological reactivity requirements for elastomeric components used with injectables. USP <1381> supplements <381> with deeper guidance on assessing elastomeric materials. In practice, USP <87> is used to establish in vitro biological reactivity during selection/qualification and is an ongoing screen post-characterization through commercialization for component material release.
  • Plastics — USP <661.1> (Materials) & USP <661.2> (Systems):
    <661.1> covers plastic materials of construction; <661.2> covers the composite plastic packaging system (e.g., bottle + closure + seal). For most non-oral/non-topical dosage forms, USP <87> cytotoxicity testing is required as part of the biocompatibility expectations in these chapters, making <87> a critical screen both during material characterization and for final system qualification (and by extension usable for release when risk-based programs call for it).

Tip: Oral and topical dosage forms generally do not require USP <87> under <661.1>/<661.2>, while other dosage forms do; a nuance our team addresses in study design and quotations.

Why Teams Choose USP <87> Early (and Often)

  • Speed & sensitivity: Quickly differentiate acceptable vs. risky materials/finishes and prioritize deeper E&L or in vivo only when justified.
  • Regulatory alignment: <87> is a recognized in vitro cytotoxicity standard widely applied in packaging and device materials strategies, aligning with the 661.1/661.2 modernization timeline (Dec 1, 2025).
  • Lifecycle utility: The same method is generally deployed later as a release or change-control check, supporting cGMP continuity for elastomers and plastics.

How CS Analytical Executes USP <87>—and Connects the Dots

We help you choose the right method (direct contact, agar diffusion, or elution) for your geometry and risk profile; set appropriate extraction conditions; run mammalian cell assays with robust controls; and deliver regulatory-ready reports. Just as important, we place results into context—bridging to elastomer requirements (USP <381> / guidance <1381>) or plastics programs (USP <661.1>/<661.2>), and aligning with your E&L strategy (USP <1663>/<1664>) when needed.

Quick Links (CS Analytical Services)