👉 The quality of an antibiotic cannot be reduced to its purity alone: it primarily depends on its actual efficacy and its safety for the patient.
- For simple antibiotics, HPLC analysis allows both the assay determination and the verification of related substances beyond established specifications.
- For complex antibiotics, the presence of multiple peaks does not allow for a reliable assay by HPLC.
Only the evaluation of antibiotic activity through a microbiological method (by diffusion or turbidimetric assay, in accordance with Ph. Eur. chapter 2.7.2 or USP chapter 81) can guarantee the true activity and efficacy of your medicinal product.
🔬 With our analytical and microbiological expertise, we combine :
- Microbiological assay to ensure the true activity of your complex antibiotics and in parallel, the implementation of a chromatographic method enables tracking of the impurity profile and any variations in related substances.
- Beyond testing, we support you at every stage :
- Development and optimization of assay methods, including sample preparation adapted to the dosage form
- Forced degradation studies
- Method validation in accordance with ICH Q2(R2)
- Raw material sourcing
- Quality control and stability studies (raw materials and finished products)
🔎 Discover our solution through this case study :
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