Standard Materials

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We qualify materials as primary reference standards with complete characterization and defined potency that can be readily used for testing needs of any regulatory submission.

Qualification of working standards against primary reference standards

Unknown impurity identification by isolation or custom synthesis.

Supporting regulatory submissions on impurity specifications.

Software-based qualification using chemical structure, and structural alert determination.

Toxicology studies.

Reference product data-based qualification

Supporting regulatory submissions on impurity specifications.