Highly potent molecules need the same analytical depth as any other API, delivered under containment that protects people and keeps the data defensible. We analyse and handle HPAPIs up to OEB5 in a GMP laboratory certified by AIFA and inspected by the FDA.
As potency rises, the number of laboratories able to work on the material falls quickly. OEB4 and OEB5 compounds require containment designed for occupational exposure limits that, for OEB5, typically sit below 1 µg/m³ — together with trained staff and procedures that hold up to an audit.
Many analytical providers stop at OEB3, or accept potent material only for a narrow set of techniques. The result is fragmentation: one site for release testing, another for solid-state characterization, a third for method development. Every transfer adds shipping risk, qualification work and weeks to the programme.
We keep the analytical work on a potent API on one GMP site, under one quality system and one chain of custody — and, where the molecule is also scheduled, under the same controlled-substance authorization.
The scope for each compound is agreed after a review of its hazard profile, so the techniques and the containment are matched to the molecule rather than to a fixed list.
Release testing, stability studies under ICH conditions, impurities and residual solvents on potent APIs and intermediates.
Methods developed and validated following ICH guidelines, with sample preparation designed to minimise exposure and material use.
Crystal form identification and thermal, spectroscopic and microscopic characterization of potent solids.
Crystal structure and absolute configuration of potent APIs, from a single crystal or, by MicroED, from very small amounts of powder.
Solubility and dissolution work for form selection and preformulation on high-potency candidates.
Identification and control of process impurities and degradation products, including forced degradation studies.
Most of the safety of a potent project is decided before the material arrives.
We review the safety data sheet, the occupational exposure limit or band, and the available toxicology. Where no limit has been assigned yet, we work from the data available and apply a conservative band.
Each technique is assigned a handling procedure suited to the band. The plan, the quantities and the timeline are agreed with you before anything is shipped.
Material arrives sealed and is logged on receipt, with quantity accountability from the first weighing.
Work is performed by trained analysts following the agreed procedures, with all raw data recorded under the GMP quality system.
Results undergo second-person review and quality assurance approval before the report is issued.
Residual material is returned or destroyed, and the reconciliation is documented.
Supplier qualification for potent work starts from these documents. Ask for copies and we send them with the quotation.
Every project ends with a detailed technical-scientific report, issued under our quality system.
Up to OEB5. The handling procedure for each technique is matched to the band of the specific compound.
Yes. Early candidates often lack a formal limit. We assess the available data with you and apply a conservative band until a limit is established.
No. The same site holds the HPAPI capability and the Ministry of Health authorization for controlled substances, so the work does not have to be split.
It depends on the techniques involved. With potent material we design the plan to use as little as possible, and confirm the exact quantity when the work is scoped.
Yes. Client audits are routine. The laboratory holds AIFA GMP certificate IT/90/H/2025 and has been inspected by the FDA.
It is returned to you or destroyed, as you prefer, and the reconciliation is documented in the project file.
Work starts only after a confidentiality agreement is in place. Samples, data and reports remain yours and are never shared or reused.
Share the safety data sheet and what you need to know about the molecule. We will come back with a containment and analytical plan, the material requirement and a timeline.