RFI Technical Questions.pdf

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Synthesis of Chemical Substances
Solicitation number
D-24-DC-0019RFI
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This document is a Request for Information (RFI) seeking information on the capability to synthesize various classes of controlled substances, including synthetic opioids, cannabinoids, cathinones, and benzodiazepines. The RFI asks questions to determine if potential vendors are registered with the DEA to handle Schedule I-V substances, their ability to synthesize these substances from starting materials, their custom synthesis capabilities and timelines, and their analytical testing and reporting capabilities. The RFI is related to a pre-solicitation from the Department of Justice Drug Enforcement Administration for studies on precursors, chemicals, and synthetic pathways used in the chemical synthesis of drug substances. The RFI requests detailed information on vendors' synthetic schemes, intermediates, by-products, impurities, yield ratios, and previous contract experience providing this type of information.

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Precursor and Methodology Profiling

Questions for RFI

1. Is your company registered as a DEA manufacturer or Researcher who can handle schedule I-V substances?

2. Can your company make necessary starting materials if unable to source them from commercial companies?

3. Describe your custom synthesis capabilities and timelines for various classes of drugs to include synthetic opioids, synthetic cannabinoids, synthetic cathinones, benzodiazepines, etc.

4. Can your company synthesize substances in the milligram to gram scale?

5. Can you company synthesize a given substance from different starting points? Are you able to utilize retrosynthetic techniques to determine various starting points in a synthetic pathway?

6. Can your company determine yield ratios and method feasibility data from numerous synthetic pathways? Describe methods and analytical techniques used.

7. Can your company provide GC-MS, NMR, HPLC, and other analytical data for intermediates, by- products, and final products in a given synthetic pathway?

8. Describe services your company can provide to (1) elucidate intermediates, by-products, final products, and impurities from varying synthetic pathways, (2) determine optimal and non-optimal reaction conditions, reagents, starting materials, precursors, and (3) generate analytical reports for each product.

9. Describe previous contract types used when providing detailed information on synthetic pathways used and analytical reports provided for a known, and unknown, number of intermediates, by-products, impurities, final products, yield ratio determinations, etc.

10. Can your company provide detailed synthetic schemes utilized or attempted when synthesizing various final products to include intermediates, by-products, and impurities formed?

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