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USP <788> Particulate Sampling Calculator

Batch size → articles to test for subvisible particulate in injectables.

Enter batch article count for USP <788> subvisible particulate sampling — same tier table as sterility, applied to injectable particulate testing for batch release planning.

Results

Articles to test

20

Minimum articles

20

Batch tier

More than 500 containers

% of batch tested

0.8%

Table 3 (parenteral): 2% or 20 containers, whichever is less → 20 article(s).

USP <788> Table 3 — parenteral: 2% or 20, whichever is less

USP <788> tier reference table
Number of articles in batchArticles to be tested
Not more than 100 containers10% (min 4)
101 to 500 containers10
check_circleMore than 500 containers2% (max 20)

Table 3 (parenteral): 2% or 20 containers, whichever is less → 20 article(s). Confirm against your current USP-NF edition, monograph, and SOP before release.

infoCompendial planning aid. Compendial planning aid only — not a substitute for your validated SOP, pharmacopeial edition in force, regulatory submission, or qualified-person release decision. Always verify sampling tables against the official USP-NF (or applicable pharmacopeia) and your quality system before testing or batch disposition.

Need expert help?

Document particulate testing in Pharma Quality Studio

Pharma Quality Studio adds method notes, OOS playbooks, and batch release sections for subvisible particulate — with Melody for QA interpretation.

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Particulate sampling pairs with sterility at release

USP <788> governs subvisible particulate in injectables — QC pulls the same style of batch-size tiers used for sterility when planning how many units to examine.

Release reviewers often need sterility, particulate, and endotoxin numbers in one sitting before signing the batch record.

This calculator applies the standard tier table for particulate planning. Pharma Quality Studio carries the full release story — specs, deviations, and PDF export.

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