Per-batch report: what every prescriber should require from the pharmacy

For those who prescribe compounded preparations — especially sterile injectables — the origin of the input is not a detail: it is the foundation of the protocol’s safety. The instrument that turns that safety into evidence is the per-batch report (certificate of analysis).

What the per-batch report is

It is the set of analyses the compounding pharmacy performs on each batch produced, attesting to the product’s identity, purity and safety. For injectables, three tests are unavoidable:

• Potency: confirms the real active concentration against what was prescribed.
• Sterility: ensures the absence of microbiological contamination.
• Bacterial endotoxins: essential in injectables, prevents pyrogenic reactions.

Why require it every time

Without a per-batch report, the prescriber takes on an invisible risk. With it, there is traceability: each vial can be linked to a set of analyses and to a regularized pharmacy (Anvisa/AFE).

How PharmaLinker helps

We work only with partner pharmacies that issue a per-batch report and keep sanitary regularity, and we provide a unified dossier for your clinic. Compliance stops being an operational worry and becomes a standard.

Read also

• Potency and stability: why the assay report matters
• Sanitary dossier: the document every clinic should require
• Compounding and injectables glossary

Informational content for healthcare professionals. PharmaLinker is a B2B intermediation platform that connects physicians and clinics with licensed compounding-pharmacy partners (regulated by Anvisa, Brazil’s health authority); it does not sell medicines, make therapeutic claims, or replace clinical judgment. Compounded preparations require a prescription.