Exhibit Batch

For tablets and capsules, FDA's stability Q&A (May 2014) says two of the three batches should be "at least 10 percent of the proposed production batch or 100,000 finished dosage units, whichever is greater". It recommends a minimum of 100,000 units in all proposed presentations. FDA does not define "exhibit batch"; this stability batch size is read across to the exhibit batch.

Other forms differ. Powders, solutions and suspensions use 10% of the maximum commercial batch. Parenterals use at least 10% of the maximum commercial batch, 50 L (fill volume above 2.0 mL) or 30 L (fill volume up to 2.0 mL), whichever is larger. Transdermal patches use 10% or 25,000 units per strength, whichever is greater. Creams, lotions and gels use 100 kg or 10% of the production batch, whichever is larger.

As of October 2026, FDA recommends three stability batches: three pilot-scale, or two pilot-scale plus one small-scale (stability Q&A, May 2014; ANDA content and format, September 2018). These are read as the exhibit batches. The guidance asks for at least 6 months (180 days) of accelerated and long-term data on each. For tablets and capsules, the third batch can be smaller than 10% but not under 25% of the pilot-scale batch.

Three stability batches that serve as exhibit batches

The same guidance requires commercial master batch records "no more than 10 times the exhibit batch(es)", plus a table comparing equipment, process parameters and in-process controls between exhibit and commercial batches.

API needed follows a simple model: units × strength in mg ÷ 1,000,000 = kg at 100% of label claim. Assay correction, overage and analytical material come on top, so treat these as minimums.

The table is arithmetic on the FDA figures above. The 100,000-unit floor keeps small commercial batches from shrinking the exhibit batch.

FDA's process validation guidance (January 2011) says a manufacturer must complete process performance qualification (PPQ, the commercial-scale validation runs) before commercial distribution. Distribution should rest on commercial-scale batch data, with pilot data as added assurance.

Route any batch-size change through change control (the documented approval process for changing a batch size or process). For handover steps, see pharmaceutical technology transfer.

Lock the API source, the lot, the quantity and the equipment comparison before the batch is made, because the filing records them. FDA's ANDA guidance asks for batch analysis, including COAs from the drug substance manufacturer, for the lots used to make the exhibit batch.

A second source needs a physico-chemical and impurity comparison and stability data on three batches of the first source. It also needs a pilot-scale batch of the second source with comparative dissolution data (FDA stability Q&A, May 2014). Confirm with your regulatory team that the API source can be referenced in your ANDA before committing the exhibit batch.

Aarise Pharmaceuticals supplies evaluation quantities of API to qualified business buyers, subject to the product, availability and applicable regulatory requirements. Quantity, pricing and documentation are confirmed product by product. Documentation may include a COA, specifications and a safety data sheet (SDS/MSDS) where applicable. After successful evaluation and approval, it can support commercial and bulk requirements.

For a quote it asks for the product name or CAS number (Chemical Abstracts Service registry number), quantity, destination, grade or purity, documents, payment terms and Incoterms (shipping terms). The steroid API RFQ checklist shows how to write that request. Supplier choice for pilot-scale API is covered in who can run your steroid API pilot batch. Its steroid raw material catalog lists the categories it supplies. Aarise also provides oral-dose contract development and manufacturing, from product development through commercial manufacturing.