Impurity Traceability & Control

The production of APIs often involves complex chemical and biological changes. As the production processes are based on chemical unit reactions and chemical unit operations, resulting in by-products, purification and refinement is quite necessary. Impurities such as API-related substances, residual organic solvents, and inorganic impurities, as well as their physical and chemical properties, the stability of APIs, and the possibility of contamination and cross-contamination are key considerations regarding the quality, safety and effectiveness of APIs.

Medicilon offers API related services including impurity identification and separation, as well as quality research and stability testing.

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(1) Preparation (or purchase) and standardization of impurities/standard samples
Preparation and standardization of API standard samplesPreparation and standardization of API and intermediate standard samplesImpurity standard samples (impurity preparation or purchase; structure identification and standardization if necessary, with impurity content of 10mg-500mg)Impurity research and impurity profiling
Medicilon employs a number of methods to determine metal impurities in API processes including inductively coupled plasma mass spectrometry (ICP-MS), inductively coupled plasma optical emission spectrometry (ICP-OES), and graphite furnace atomic absorption spectrometry (GFAAS).

(2) Quality research
Critical quality attributes (CQA)Physical and chemical properties (salt types, crystal forms, and particle sizes)Impurities (related substances, residual solvents, genotoxic impurities, elemental impurities, and chirality)Preparation of draft material quality standardsDevelopment of analytical methodsContent analysisMaterial inspections and releaseCentral control analysisValidation of analytical methods (HPLC, chiral HPLC, GC-HS)

(3) API stability tests
Influencing factors (1 month)Accelerated stability (6 months)Long-term stability (tentatively 24 months)

Relevant laboratories