USDA-APHIS-WS requires a set of product chemistry registration studies (following EPA’s study guideline
OPPTS 830.1700 [1]) to be completed on a manufacturing source of an active ingredient (sodium nitrite)
in accordance with Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Good Laboratory
Practices (GLPs) [2]. This study must characterize the active ingredient sodium nitrite, the major impurity
sodium nitrate, and loss on drying in each of the 5 batches.
As part of this contract, we will need the contract laboratory to produce GLP-compliant Certificates of
Analysis (CoA) for the two reference standards, sodium nitrite and sodium nitrate, that will be used in
the subsequent preliminary (5-batch) analysis study.