1491004

Oxytetracycline

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): Oxytetracycline dihydrate
• Empirical Formula (Hill Notation): C₂₂H₂₄N₂O₉ · 2H₂O
• CAS Number: 6153-64-6
• Molecular Weight: 496.46
• NACRES: NA.24
• PubChem Substance ID: 329750649
• UNSPSC Code: 41116107
• EC Number: 201-212-8
• MDL number: MFCD00151234

Properties

• grade: pharmaceutical primary standard
• agency: USP
• API family: oxytetracycline
• form: solid
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule); pharmaceutical
• format: neat
• SMILES string: O.[H][C@@]12[C@@H](O)[C@@]3([H])C(C(=O)c4c(O)cccc4[C@@]3(C)O)=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@H]2N(C)C
• InChI: 1S/C22H24N2O9.H2O/c1-21(32)7-5-4-6-8(25)9(7)15(26)10-12(21)17(28)13-14(24(2)3)16(27)11(20(23)31)19(30)22(13,33)18(10)29;/h4-6,12-14,17,25,27-29,32-33H,1-3H3,(H2,23,31);1H2/t12-,13-,14+,17+,21-,22+;/m1./s1
• InChI key: IBZHEBHGZFICKS-IFLJXUKPSA-N

Description

General description

Find answers to frequently asked questions on USP products in USP FAQs.

Oxytetracycline is a broad-spectrum tetracycline antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. It is effective against a range of Gram-positive and Gram-negative organisms. The USP reference standard ensures assay precision and identity confirmation in oxytetracycline drug products.

The USP biologics antibiotics category includes a wide range of antimicrobial agents that are essential in treating bacterial infections. These antibiotics are derived from various natural sources or synthesized to combat specific pathogens effectively. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of antibiotic therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

Application

Oxytetracycline USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:

• Oxytetracycline Hydrochloride
• Oxytetracycline Injection
• Oxytetracycline Tablets
• Oxytetracycline for Injection
• Oxytetracycline Hydrochloride Capsules
• Oxytetracycline Hydrochloride Soluble Powder

Biochem/physiol Actions

Antibiotic produced by Streptomyces rimosus.
Mode of Action: Inhibits protein synthesis (elongation) by preventing binding of aminoacyl-tRNA to the 30S subunit.
Antimicrobial spectrum: Gram-negative and Gram-positive bacteria.
Mode of Resistance: Active efflux, ribosome protection, tetracycline inactivation.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

This product is part of USP Biologics Program.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

Safety Information

• Pictograms: GHS08,GHS09
• Signal Word: Warning
• Hazard Codes: H361d,H411
• Precautionary Statements: P202 - P273 - P280 - P308 + P313 - P391 - P405
• Hazard Classifications: Aquatic Chronic 2 - Repr. 2
• Storage Class: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point (°F): Not applicable
• Flash Point (°C): Not applicable