FIFRA GLP Preliminary (5-batch) Analysis Study for Sodium Nitrite 12639525Q0136

The purpose of the modification is to extend the response date until July 8th All other terms and conditions remain the same􀀰 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.

The purpose of the modification is to extend the response date until July 8th, and change the classification to Full and Open. All other terms and conditions remain the same􀀰 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.

The purpose of the modification is to extend the response date until July 8th, and change the classification to Full and Open. All other terms and conditions remain the same. 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.