Five-batch testing (or preliminary analysis) is performed to account for at least 98% of the composition of a technical grade active ingredient (TGAI). This characterization data is required to support the registration of a TGAI. Smithers will help you develop the analytical strategy needed to identify and quantify active ingredients and significant and relevant impurities down to the level of 0.1% (or lower for toxic/relevant impurities) within production batches of pesticides, biocides, and other industrial substances from the manufacturing line or along intervals across a continuous process.
Our team will work with you to review the manufacturing process to identify what components to expect and potential impurities in the reagents used in the process. Smithers has over 20 years of experience testing pure, synthesized chemistries of solids, liquids, and gases, in addition to plant extracts and other complex substances that require uniquely tailored analytical approaches.
The instrumentation available at Smithers allows for the appropriate screening, method development / validation (compliant with SANCO 3030/99 rev.5), purification techniques, as well as structural elucidation required to perform 5-batch testing on a variety of materials. Testing services are performed and reported in accordance with OCSPP 830:1700 and OCSPP 830.1800, as well as European and worldwide requirements (South America, FAO and IUPAC specifications). Our non-agricultural and biocide testing requirements also meet the US requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; 7 U.S.C. 136) and the Toxic Substances Control Act (TSCA; 15 U.S.C 2601), plus European and other worldwide guidelines.
What happens next?
Smithers will work with you to advise the best 5-batch testing approach for a new product or for an existing product that has undergone a change in the manufacturing process or manufacturing site. Contact us to learn more.
Our team will work with you to review the manufacturing process to identify what components to expect and potential impurities in the reagents used in the process. Smithers has over 20 years of experience testing pure, synthesized chemistries of solids, liquids, and gases, in addition to plant extracts and other complex substances that require uniquely tailored analytical approaches.
The instrumentation available at Smithers allows for the appropriate screening, method development / validation (compliant with SANCO 3030/99 rev.5), purification techniques, as well as structural elucidation required to perform 5-batch testing on a variety of materials. Testing services are performed and reported in accordance with OCSPP 830:1700 and OCSPP 830.1800, as well as European and worldwide requirements (South America, FAO and IUPAC specifications). Our non-agricultural and biocide testing requirements also meet the US requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; 7 U.S.C. 136) and the Toxic Substances Control Act (TSCA; 15 U.S.C 2601), plus European and other worldwide guidelines.
What happens next?
Smithers will work with you to advise the best 5-batch testing approach for a new product or for an existing product that has undergone a change in the manufacturing process or manufacturing site. Contact us to learn more.
