Antibiotic potency determination is a cornerstone of pharmaceutical research and development, manufacturing and quality control, serving as the critical link in assessing the activity and efficacy of antibiotic drugs.
Antibiotic potency testing quantitatively analyzes an antibiotic’s ability to inhibit specific microorganisms, ensuring it meets clinical treatment needs and quality standards.
Because antibiotics vary widely in type, mechanism of action and sensitivity to external factors such as strain sensitivity, culture conditions and experimental methods, standardized potency tests are required to verify biological activity. Pharmacopoeias – including the Chinese Pharmacopoeia (ChP), the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP) – along with regulatory authorities worldwide, explicitly mandate antibiotic potency testing to ensure drug safety and efficacy.
Reference strains are critical for ensuring comparability and reproducibility of potency testing. With stable genetic characteristics and predictable sensitivity, they provide a reliable benchmark for evaluating antibiotic activity.
In line with USP-NF 81 and the ChP, reference strains must be regularly traced to their source and verified for activity to ensure accuracy and reliability of results.
To overcome variability and ensure reproducibility, laboratories adopt strict error-control measures:
With comprehensive capabilities and extensive project experience, our experts can rapidly design scientific, compliant testing protocols tailored to different antibiotic types. We have developed a comprehensive suite of development and validation protocols and standardized operating procedures (SOPs), enabling efficient, precise testing services for global clients. To ensure accuracy and reliability, all SGS laboratories use authenticated reference strains as the foundation of antibiotic potency testing.
| Standard | Testing capabilities | Project experience | Advantages |
|---|---|---|---|
| ChP2020, Part Four, General Principles 1201 |
| Potency determination for various antibiotics, including amphotericin B, gentamicin, novobiocin, bleomycin, erythromycin, neomycin and bacitracin | PASS |
| USP 81 | |||
| EP 2.7.2 |
Operating under cGMP-qualified laboratory requirements, our antibiotic potency testing teams provide customized protocol design, data verification and global regulatory compliance support. Through these capabilities, we help enterprises achieve efficient product release while maintaining the highest standards of safety, efficacy and regulatory alignment.
For further information, please contact:
Colton Wong PhD CChem CSci MRSC
Health & Nutrition
dVP, Pharma Asia Pacific
m: +852 6018 3632 (Hong Kong); +86 158 0062 3483 (China); +886 905 801 833 (Taiwan)
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