Antibiotic Standards

The world depends on a consistent supply of safe and effective antibiotics that serve as a first line of defense against a wide variety of potentially dangerous bacteria. Consistent antibiotic quality is essential, especially considering the growing threat posed by antimicrobial resistance (AMR). Substandard antibiotics allow AMR to flourish, potentially rendering the antibiotic widely ineffective. Manufacturers, regulators, and patients need confidence in the quality control standards and testing of antibiotics to avoid the dangerous threat of increased resistance.

USP is committed to providing documentary and physical reference standards to assist manufacturers and national control laboratories who test medicines used to treat life threatening, yet common diseases such as meningitis and pneumonia. In addition to developing and updating quality standards, USP supports initiatives for the development of new antimicrobial drugs and publishes antibiotic-related USP–NF monographs that support the quality of antibiotic medicines.

USP Antibiotic Families

USP monographs for antibiotics reflect the quality attributes of items approved by the U.S. Food and Drug Administration. USP supports entry of new manufacturers of generic versions of antibiotics with reference standards for their active pharmaceutical ingredient (API), as well as related system suitability, known impurities, and excipients present in the final drug product.

Please click on the antibiotic you are interested in to learn more.

The USP Amphotericin antibiotic family includes:

The USP Bacitracin Zinc antibiotic family includes:

The USP Bleomycin Sulfate antibiotic family includes:

The USP Capreomycin Sulfate antibiotic family includes:

The USP Chloramphenicol antibiotic family includes:

The USP Chlortetracycline Hydrochloride antibiotic family includes:

The USP Colistimethate antibiotic family includes:

The USP Colistin Sulfate antibiotic family includes:

The USP Dihydrostreptomycin Sulfate antibiotic family includes:

The USP Gentamicin Sulfate antibiotic family includes:

The USP Gramicidin antibiotic family includes:

The USP Neomycin antibiotic family includes:

The USP Novobiocin Sodium antibiotic family includes:

The USP Nystatin antibiotic family includes:

The USP Oxytetracycline antibiotic family includes:

The USP Paromomycin Sulfate antibiotic family includes:

The USP Penicillin G Potassium antibiotic family includes:

The USP Polymyxin B antibiotic family includes:

The USP Sisomicin Sulfate antibiotic family includes:

The USP Thiostrepton antibiotic family includes:

The USP Tylosin antibiotic family includes:

The USP Vancomycin Hydrochloride antibiotic family includes:

What's New

Antibiotics Manufacturing and Testing

Infographic

Antibiotics Manufacturing and Testing

Ensure consistency of drug potency

USP Bioassay Reference Standards

Enabling consistent potency measurements over a drug's lifetime

 

Antimicrobial Resistance

Antimicrobial Resistance

Learn more about how USP is helping address the global threat of AMR.

 

 

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