Drug Product

Consistent Quality. Confirmed Compliance. Every Batch.

In pharmaceutical manufacturing, a single out-of-specification result can trigger a deviation investigation, delay a batch release, or in the worst case, pull a product from the line entirely. With GMP requirements leaving no room for interpretation, manufacturers need testing programs that catch variability before it reaches the patient, not after.

Drug product, or finished dosage form (tablet, capsule, injectable), combines a drug substance (API) with excipients into the final product administered to patients. Confirming that combination meets specification either in a solid dosage form or a liquid formulation, requires more than routine checks. It requires validated, reproducible finished dosage form testing across identity, strength, purity, and performance attributes at every stage of the batch lifecycle - from raw material and polymorphic form identification, to contamination screening, to extractables and leachables and residual solvents testing

GMP compliance is non-negotiable, and drug product release testing is the final gate before a batch reaches the market. It's the point where analytical rigor translates directly into regulatory confidence, and where gaps in method validation or instrument performance become costly delays rather than minor inconveniences.

PerkinElmer's analytical instrumentation, informatics solutions, and service support are built to help pharmaceutical manufacturers maintain drug product quality consistently across every batch and dosage form; supporting compliance from development through commercial release.

Reliable methods. Defensible data. Compliant release.