USP Antibiotics Families

USP standards can help manufacturers develop generic versions of off-patent antibiotic drugs and assist national control laboratories testing these essential medicines. USP standards help promote a strong, resilient medicine supply chain – crucial for patients to receive safe and effective medicines when they need them.

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.

USP reference standards are linked to official USP monographs that definitively describe specifications for evaluating a medicine’s identity, purity, potency, and performance. They can be used to validate system suitability of analytical methods and equipment as well as for quality control of drug substance batches as required by monograph methods.

Amphotericin B	Colistimethate Sodium	Neomycin Sulfate	Polymyxin B
Bacitracin	Colistin Sulfate	Novobiocin	Sisomicin Sulfate
Bleomycin Sulfate	Dihydrostreptomycin Sulfate	Nystatin	Thiostrepton
Capreomycin Sulfate	Erythromycin	Oxytetracycline	Tylosin
Chloramphenicol	Gentamicin Sulfate	Paromomycin Sulfate	Vancomycin
Chlortetracycline Hydrochloride	Gramicidin	Penicillin G

To learn about all our antibiotic standards, materials, and resources, please visit the USP Antibiotics page.

Amphotericin B antibiotic family

The USP Amphotericin antibiotic family includes:

USP Monograph: Amphotericin B
API: Amphotericin B Reference Standard

Bacitracin Zinc antibiotic family

The USP Bacitracin Zinc antibiotic family includes:

USP Monograph: Bacitracin Zinc
API: Bacitracin Zinc Reference Standard

Bleomycin Sulfate antibiotic family

The USP Bleomycin Sulfate antibiotic family includes:

USP Monograph: Bleomycin Sulfate
API: Bleomycin Sulfate Reference Standard

Capreomycin Sulfate antibiotic family

The USP Capreomycin Sulfate antibiotic family includes:

USP Monograph: Capreomycin Sulfate
API: Capreomycin Sulfate Reference Standard

Chloramphenicol antibiotic family

The USP Chloramphenicol antibiotic family includes:

USP Monograph: Chloramphenicol
API: Chloramphenicol Reference Standard

Chlortetracycline Hydrochloride antibiotic family

The USP Chlortetracycline Hydrochloride antibiotic family includes:

USP Monograph: Chlortetracycline Hydrochloride
API: Chlortetracycline Hydrochloride Reference Standard

Colistimethate antibiotic family

The USP Colistimethate antibiotic family includes:

USP Monograph: Colistimethate Sodium
- Revised monograph resulting from modernization review – will be active as of 01-AUG-2024.
APIs: Colistimethate Sodium Reference Standard
Impurities:
- NEW! Colistimethate Mixture A Reference Standard
- NEW! Colistimethate Mixture B Reference Standard
Supporting documentation
- COMING SOON! Quality Solution Sheet: Colistimethate