XRPD Testing of Cytotoxic & HPAPI Compounds
Safe handling, measurement, and sealed archiving of highly potent and cytotoxic pharmaceutical compounds — in an EU cGMP containment laboratory with full confidentiality.
The Challenge with Potent Compounds
Cytotoxic APIs and highly potent active pharmaceutical ingredients (HPAPIs) — including oncology drugs, cytostatics, and hormonal compounds — require specialized handling at every stage of analysis. Standard XRPD laboratories cannot safely process these materials because uncontained exposure risks contamination of other samples and poses serious health hazards to laboratory personnel.
Pharmaceutical companies developing or manufacturing potent compounds face a practical problem: few contract laboratories have both the containment infrastructure for safe handling and the cGMP quality system required for regulatory-grade XRPD data. DANNALAB solves both requirements in a single facility.
Containment & Safety Capabilities
Enclosed Sample Handling
Cytotoxic and HPAPI samples are handled in sealed containment systems throughout the entire workflow — from receipt and unpacking through sample preparation, XRPD measurement, and post-analysis archiving. No open handling of potent compounds occurs at any stage.
Cross-Contamination Prevention
Dedicated containment protocols ensure that potent compounds cannot contaminate other client samples or the laboratory environment. Cleaning validation and surface monitoring procedures are in place between projects.
Personnel Protection
All handling follows occupational exposure limit (OEL) requirements. Staff are trained in cytotoxic compound procedures. Personal protective equipment and engineering controls meet pharmaceutical industry standards for potent compound handling.
Sealed Sample Archiving
DANNALAB operates a proprietary sealed sample storage system specifically designed for the retention of hazardous pharmaceutical materials. After measurement, cytotoxic and HPAPI samples are sealed under controlled conditions with full traceability, enabling:
- GMP-compliant retention — Samples stored for agreed retention periods under conditions that preserve integrity and prevent degradation
- Reanalysis capability — Archived samples remain accessible for repeat XRPD measurement if questions arise during regulatory review, stability reassessment, or post-market surveillance
- Safe disposal — When retention periods expire, samples are disposed of according to cytotoxic waste handling regulations
- Full chain of custody — Every handling event is documented, from receipt through archiving to eventual disposal or return
XRPD Testing Capabilities for Potent Compounds
All standard XRPD services are available for cytotoxic and HPAPI samples — the containment infrastructure does not limit the analytical capability:
Polymorph Identification
Confirm polymorphic form of cytotoxic APIs against reference standards.
Batch Release Testing
cGMP batch release with QA-approved CoA for potent drug products.
Crystallinity Quantification
Amorphous/crystalline ratio determination. LOQ ~1% wt.
Method Development
ICH-compliant method validation for potent compound matrices.
Micro-quantities: DANNALAB can perform XRPD measurements on samples as small as 2 mg — particularly relevant for HPAPIs where material availability is limited and cost per gram is high.
Types of Compounds We Handle
Oncology Drugs
Cytostatic agents, targeted therapy compounds, and anti-cancer APIs — including taxanes, platinum compounds, anthracyclines, and alkylating agents.
HPAPIs
Highly potent APIs with occupational exposure limits (OELs) in the microgram range. Compounds classified as OEB 4–5 (Safebridge or equivalent categorization).
Hormonal Compounds
Steroidal APIs and hormonal drug substances requiring containment to prevent cross-contamination and protect personnel from endocrine-active exposure.
Regulatory Compliance & Confidentiality
EU cGMP Certified
cGMP compliance confirmed by the Dutch Health Care Inspectorate. Manufacturing and Importation Authorization (MIA) held. Certificates available in EudraGMDP database.
21 CFR Part 11
All electronic records meet 21 CFR Part 11 requirements. Audit trails, controlled access, and traceable data for every measurement.
Strict Confidentiality
Client NDAs accepted as-is before any sample shipment. Cytotoxic and oncology drug projects are particularly sensitive — DANNALAB maintains strict information barriers between client projects.
Discuss Your Potent Compound Project
Tell us the compound class, OEL category, required analysis, and timeline. We respond within 24 hours with a feasibility assessment and quote. NDA signed before any details are exchanged if requested.