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FDA: specification limits are typically set against the API; strength‑based limits allowed only in wide MDD ranges
Summary
FDA staff said specification limits for nitrosamines are generally set against the API and thus do not vary by strength; however, when a product's maximum daily dose (MDD) varies widely across strengths, the agency may accept different limits on a case‑by‑case basis and advised sponsors to submit control correspondence for specific queries.
An in‑person attendee asked whether manufacturers may set different nitrosamine specification limits by strength (for example, different limits for 25, 50, 75 and 100 mg strengths). An agency official explained that specification limits are normally defined against the API, so the nitrosamine level would be tied to API content rather than the product strength; however, when products exhibit very wide maximum daily dose (MDD) ranges across strengths, FDA can consider different limits with appropriate justification.
The official said applicants should provide proper justification and noted that "sometimes the pharma allows you using different MDD for different dose when you have a big range...it's still case by case." Shruti King recommended that sponsors seeking adjustments should submit a control correspondence to the Office of Generic Drugs (OGD) for a specific determination.
