In pharmaceutical intermediate manufacturing, control over residual solvents and organic impurities is just as important as the primary assay. International pharmacopeia guidelines (such as ICH Q3C and USP) enforce strict limits on Class 2 and Class 3 solvents to guarantee patient safety.
Using state-of-the-art Gas Chromatography (GC) with headspace injection and high-performance liquid chromatography (HPLC), our analytical laboratories track every single impurity down to ppm levels. This ensures that solvents like ethanol, ethyl acetate, or trace halogenated compounds remain well within safe thresholds.
Every commercial batch shipped from Hongtai Pharma™ comes with a comprehensive Certificate of Analysis (COA) detailing exact impurity profiles and moisture content, giving formulators complete peace of mind.
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