Set up the comparison
Compare the proposed acetaminophen lot with the approved material. Record known solid-state or size information, analytical method and process conditions for change assessment.
Measurements to record
Assay (% on a dry basis). This is a drug-substance monograph definition. Identify the applicable edition in the contract. Related substances including p-aminophenol (% / ppm). Request the method and limit of quantification. Report each specified analyte individually. Record the sample ID and method revision for repeat testing.
Interpreting the results
Separate raw material release from suitability for the dosage-form process. Have the pharmaceutical quality team evaluate any change under its approved procedure.
What to record
- Raw material lot
- Particle-size method
- Process conditions
- Change under review
- Assessment
Technical references
Products and processes
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