Chemical Compound Storage

化合物储存

• 批准号: 10710084
• 金额: $ 0.08万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-27 至 2022-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710084
• 关键词: Authorization documentation; Catalogs; Chemicals; Contractor; Contracts; Deterioration; Drug abuse; Equipment and supply inventories; Evaluation; Government; Guidelines; Label; Life; National Institute of Mental Health; Peptides; Pharmaceutical Preparations; Procedures; Program Accessibility; Research; Resources; Time; Update; Work; base; chemical synthesis; programs; radiochemical; repository; research and development; web site

The Contractor shall produce, analyze for authenticity and purity, and store labeled and unlabeled chemical compounds (including peptides) upon government authorization. The Contractor shall receive, store, and maintain compounds, along with analytical and technical information, from the NIMH Chemical Synthesis and Drug Supply (CSDSP) inventory (to be transitioned from contract HHSN271201400001l). Requests for compounds in the inventory shall be submitted to the Contractor through the publicly accessible program website which shall be maintained by the Contractor (https://nimh-repository.rti.org/). The Contractor shall maintain the website with the following information: a description of the CSDSP, a up-to-date list of compounds available in the NIMH inventory, and procedures and forms for submitting requests for chemical synthesis or for compounds. The Contractor shall perform an on going evaluation of the stability of inventoried chemical compounds (labeled and unlabeled) and maintain research and development work continuously. The evaluation shall be conducted at the time a compound is requested, upon approval of the COR. The need for purity evaluation should be based on the date since the last assessment of a compound and the known stability of the compounds under the optimal shelf-life conditions in which they are maintained. Repurification shall be carried out if chemical or radiochemical deterioration occurs. The Contractor shall identify, acquire, and update the drug supply inventory (research resources/catalog) with new or latest discovered chemical compounds useful for drug abuse research and any new guidelines for the program.

承包商应在政府授权后生产，分析真实性和纯度，并存储标记和未标记的化合物（包括肽）。承包商应从NIMH化学合成和药物供应（CSDSP）库存（将从合同HHSN2712014001L过渡），从NIMH化学合成和药物供应（CSDSP）库存中接收，存储和维护化合物以及分析和技术信息。库存中的化合物请求应通过公共访问的计划网站提交给承包商，该网站应由承包商（https://nimh-repository.rti.org/）维护。承包商应使用以下信息维护网站：CSDSP的描述，NIMH库存中可用的化合物的最新列表，以及提交化学合成请求或化合物请求的程序和表格。承包商应在评估库存化合物的稳定性（标记和未标记）并持续维护研究和开发工作时进行评估。评估应在COR批准后在要求时进行化合物进行。对纯度评估的需求应基于自上次评估以来的日期，并且在维持其维持的最佳保质期条件下的化合物的已知稳定性。如果发生化学或放射化学恶化，则应进行重新认可。承包商应使用新的或最新发现的化学化合物对药物滥用研究和任何新的计划的新准则来识别，获取和更新药物供应清单（研究资源/目录）。