Key Starting Materials (KSMs) set the quality foundation for an active pharmaceutical ingredient. Chemspectrum manufactures KSMs and key intermediates under stringent quality controls, with defined impurity profiles and high purity standards.
Processes are documented and controlled to support our customers' regulatory requirements in international markets, with traceability from raw material to finished batch.
Key starting materials made to agreed specifications for API manufacturers.
Impurity profiles monitored and controlled through each stage.
Testing in our QC laboratory using GC, HPLC and other instruments.
Batch records linking raw materials, process data and final release.
Documentation to support customers' regulatory filings.
Planned capacity for long-term, repeat requirements.
Incoming materials are checked against defined specifications.
Critical parameters are monitored throughout production.
Each batch is analysed and its records are reviewed.
Approved batches are released with full documentation.
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