مساء الخير يا دكاتره
ممكن حد يعرفني what the different between related substances and Impurities in raw materials ....
وياريت لو حد يعرف داتا كويسه افهم منها موضوع related and impurities اكون شاكر له
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مساء الخير يا دكاتره
ممكن حد يعرفني what the different between related substances and Impurities in raw materials ....
وياريت لو حد يعرف داتا كويسه افهم منها موضوع related and impurities اكون شاكر له
Briefly; Impurities are the main huge tree! while related substances are considered branch of that tree.
A good guidance is ICH Q3A.
In details; according to ICH Q3A; Impurities can be classified into the following categories:
Organic impurities (process- and drug-related; related substances)
Inorganic impurities
Residual solvents
Organic impurities can arise during the manufacturing process and/or storage of the drug substance. They can be identified or unidentified, volatile or non-volatile, and include:
- Starting materials
- By-products
- Intermediates
- Degradation products
- Reagents, ligands and catalysts
Inorganic impurities can result from the manufacturing process. They are normally known and identified and include:
Reagents, ligands and catalysts
Heavy metals or other residual metals
Inorganic salts
Other materials (e.g., filter aids, charcoal)
Solvents are inorganic or organic liquids used as vehicles for the preparation of solutions or suspensions in the synthesis of a new drug substance.