14C-labeled API Quality Control

14C-labeled active pharmaceutical ingredients (APIs) need to undergo comprehensive testing in a GMP analytical laboratory to confirm their identity, purity and efficacy. A series of advanced instruments and methods, including high-performance liquid chromatography (HPLC) / ultra-high performance liquid chromatography (UHPLC) for radiochemical purity, mass spectrometry (MS) and nuclear magnetic resonance (NMR) for structural identification, gas chromatography for residual solvent detection, and liquid scintillation counting for radioactivity, are used to ensure that the products meet all specifications. Each result should be recorded in a complete analysis data package, and a formal analysis certificate (CoA) should be issued, which details information such as chemical purity, radiochemical purity, specific activity, etc.

Method Transfer Services

Amerigo Scientific offers analysis method transfer services for 14C-labeled API manufacturing campaign. Our HPLC and UHPLC method transfer services, executed by well-trained and experienced personnel, and in accordance with USP <1224> under Revalidation.

Our services ensure:

• Result consistency: The same quality data can be obtained in the receiving laboratory.
• Compliance: Meeting the requirements of regulatory agencies for drug quality control.
• Efficiency and cost control: Avoiding the repeated development and validation of methods, saving time and resources.

Amerigo Scientific offers two service options for method transfer.

Release Testing Services

The relevant materials will be reviewed and then a formal release specification will be drafted for our clients to review and approval. Once the GMP API production is completed, our quality control department team will analyze the materials according to the agreed-upon formal release specification. The advanced instruments are used for accurate and reproducible analysis of GMP APIs. These instruments are carefully maintained, operated in accordance to GMP-compliant operating procedures, and qualified by certified on-site service engineers.

Our GMP release testing service options include:

Stability Study Services

Amerigo Scientific offers GMP stability study services through using qualified instruments in a dedicated quality control laboratory for safe storage and analysis. We offer reliable GMP stability studies including:

• Stability chambers equipped with 24/7 temperature monitoring systems
• Aliquot preparation for all required time points and storage conditions
• Analysis according to the approved stability study protocol
• All results and a final stability report
• COA with updated re-testing dates (if applicable)

The GMP stability chambers are continuously monitored by the Rees Scientific Environmental Monitoring System that complies with 21 CFR Part 11. Temperatures in all test chambers are recorded, and the relative humidity in the +25°C/60% RH chamber is also recorded. Periodic requalification of stability test chambers is conducted through Rees Scientific Temperature Mapping. Results of stability tests at each test time point are provided, and a final stability report is provided at the end of the stability study to summarize the test results at all time points.

The stability of radiolabeled products generated in non-GMP technical batches typically needs to be analyzed to obtain stability data before the completion of GMP batches. Stability studies of technical-batch products offer multiple benefits, including:

• Evaluating the stability of radiolabeled products under the same dosing/storing conditions as planned for GMP batches
• Testing various potential storage conditions for GMP batches
• Providing information for the dosing schedule and packaging decisions for GMP batches