Qualified Research

Can Formulation Stability Testing Qualify as R&D?

Formulation stability testing may constitute qualified research when the testing evaluates alternative formulations to resolve a technical uncertainty about stability performance. Routine stability testing against known targets generally is not qualified research.

A common question from chemical and food manufacturers is whether formulation stability testing can qualify as research and development for the federal R&D tax credit under Section 41. The short answer is that formulation stability testing may constitute qualified research when the testing evaluates alternative formulations to resolve a technical uncertainty about stability performance. Routine stability testing against known targets generally is not qualified research. This page explains the framework in general terms. It is educational and is not individualized advice. For the foundational framework, see our page on qualified research.

When Stability Testing May Warrant Review

Formulation stability testing may warrant review when the work involves a genuine technical uncertainty and a process of experimentation. Under the four-part test, the work must be for a permitted purpose, be technological in nature, be intended to eliminate uncertainty, and be conducted through a process of experimentation.

Common scenarios that may warrant review include:

  • New formulation stability — evaluating alternative formulations to resolve uncertainty about whether a new formulation can achieve the required stability.
  • Separation — testing alternative approaches to resolve uncertainty about whether a formulation can resist separation over the required shelf life.
  • New condition — evaluating alternative formulations to resolve uncertainty about stability under a new condition (temperature, humidity).
  • Stability target — testing alternative approaches to resolve uncertainty about what stability a new formulation can achieve.

Routine Testing vs. Development Testing

A central distinction is between routine stability testing and development testing:

  • Routine testing — testing a formulation to verify that it meets an established stability target. This is verification, not research.
  • Development testing — testing alternative formulations to resolve a technical uncertainty about stability where the stability is not established. This may warrant review.

Hypothetical Example

Consider a manufacturer that is developing a new formulation and is uncertain whether any available approach can achieve the required stability over the shelf life. The company evaluates alternative formulations, tests each for stability, and systematically varies the approach to resolve the uncertainty. This systematic evaluation of alternatives may warrant review as qualified research.

By contrast, if the same manufacturer tests a production formulation to verify that it meets an established stability target, that is routine testing, not research.

This example is illustrative only and does not state that the activity definitely qualifies.

Documentation That May Help

Records that can help support stability testing claims include test plans identifying the uncertainty and alternative formulations, stability test results, and records of how results informed formulation changes. For more, see our page on R&D tax credit documentation.

Key Takeaway

Formulation stability testing may constitute qualified research when the testing evaluates alternative formulations to resolve a technical uncertainty about stability performance. Routine stability testing against known targets generally is not qualified research. Because the distinction is fact-specific, professional review is appropriate before claiming the credit.

Sources

  1. Treasury Regulation §1.41-4

    Cornell Law Institute (LII)

    Defines the process of experimentation as an evaluative process of alternatives and the elimination-of-uncertainty requirement.

  2. Internal Revenue Code §41

    Cornell Law Institute (LII)

    Section 41(d) defines qualified research and the four-part test.

  3. Instructions for Form 6765

    Internal Revenue Service

    Summarizes qualified research and excluded activities.

  4. Research Credit

    Internal Revenue Service

    IRS landing page for the Credit for Increasing Research Activities.

By R&D Ledger Editorial Team

Last reviewed: August 2026

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