Chemical Compound Storage
Chemical Compound Storage
批准号:
10710084
负责人:
金额:
$0.08万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-05-27 至 2022-06-15
关键词:
Authorization documentationCatalogsChemicalsContractorContractsDeteriorationDrug abuseEquipment and supply inventoriesEvaluationGovernmentGuidelinesLabelLifeNational Institute of Mental HealthPeptidesPharmaceutical PreparationsProceduresProgram AccessibilityResearchResourcesTimeUpdateWorkbasechemical synthesisprogramsradiochemicalrepositoryresearch and developmentweb site
中文摘要
经政府授权,承包商应生产、分析其真实性和纯度,并储存已标记和未标记的化合物(包括多肽)。承包商应从NIMH化学合成和药物供应(CSDSP)库存(从合同hhsn2712014000011过渡)中接收、储存和维护化合物以及分析和技术信息。对库存中化合物的请求应通过承包商维护的可公开访问的项目网站(https://nimh-repository.rti.org/)提交给承包商。承包商应在网站上提供以下信息:CSDSP的说明、NIMH库存中可用化合物的最新清单,以及提交化学合成或化合物请求的程序和表格。承包商应对库存化合物(已标记和未标记)的稳定性进行持续评估,并持续保持研究和开发工作。在获得COR批准后,应在要求化合物时进行评估。纯度评估的需要应基于上次评估化合物的日期以及化合物在最佳保存期限条件下的已知稳定性。发生化学或放射线化学变质时,应进行再净化。承包商应识别、获取和更新药物供应清单(研究资源/目录),其中包含对药物滥用研究有用的新的或最新发现的化合物,以及项目的任何新指南。
英文摘要
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.
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