Manufacturing process
Assess starting materials, reactions, purification, process controls and the plausible formation or carryover of impurities.
Pesticide product chemistry data review
Chemistry that defines
the product clearly.
Scientific review of manufacturing information, composition, specifications, impurities, analytical methods and physical-chemical data for Canadian pesticide applications.
Chemistry questions travel through the file
One inconsistency can change
more than one data requirement.
A manufacturing description, five-batch analysis, specification and analytical method may each look acceptable on its own while describing slightly different products. Those differences can affect impurity limits, source equivalence, study relevance and the Statement of Product Specification Form.
Our review follows those connections and identifies where the record needs correction, explanation or additional evidence before submission.
Where we add value
Review at the points where
chemistry becomes regulatory.
Specifications and five-batch data
Evaluate whether certified limits are supported by representative batch results and aligned across documents.
Impurity assessment
Examine identified, unidentified and potentially toxicologically significant impurities and the rationale for proposed limits.
Analytical methods
Review method suitability, validation, analyte coverage and the relationship between reported results and regulatory specifications.
Physical and chemical properties
Check study design, test material, endpoints, applicability and internal consistency with the proposed product.
A focused engagement
Review the whole package or
the issue under scrutiny.
The assignment can cover a complete chemistry data package or a defined concern such as a second manufacturing site, impurity profile, method validation or five-batch analysis.
- 01Technical active ingredient manufacturers
- 02Formulators and end-use product registrants
- 03Alternate manufacturing sites and sources
- 04Chemistry packages prepared outside Canada
- 05Applicants responding to product-identity questions
A chemistry package that describes
one defensible product.
You receive a prioritized assessment of the chemistry record, including inconsistencies, evidence gaps and recommended corrective actions.
Where the evidence supports a rationale rather than new testing, that opportunity is identified and assessed on its scientific merits.
Start with the file in front of you
Need an expert review of
the chemistry file?
Send the product type and a brief inventory of the manufacturing, specification, batch-analysis and analytical information available.
Discuss your project info@agrochemconsulting.com