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Quality Control
Chemical synthesis
Solid phase synthesis monitoring: Control the amount of reagents, reaction time and temperature in key steps such as coupling reactions and deprotection groups.
Automatic equipment calibration: Regular calibration of the automatic peptide synthesizer to ensure a stable synthesis process.
Intermediate testing: Sampling of the intermediates for each synthesis step (e.g., HPLC testing).
Purification
Purity requirements: Purification by high performance liquid chromatography (HPLC) or preparative HPLC, ensuring that the main peak purity is usually above 95%.
Residual solvent detection: Detection of residual solvents in purified samples by gas chromatography (GC).
Freeze-dried and packaged
• Freeze-drying process control: Optimize the freeze-drying process to avoid peptide denaturation or inactivation.
• Aseptic packaging: For pharmaceutical or injectable products, packaging must be completed in a sterile environment to avoid microbial contamination.