PHR1537

Oxytetracycline

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Oxytetracycline dihydrate, OTC
• Empirical Formula (Hill Notation): C₂₂H₂₄N₂O₉ · 2H₂O
• CAS Number: 6153-64-6
• Molecular Weight: 496.46
• EC Number: 201-212-8
• MDL number: MFCD00151234
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823449
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 782; traceable to Ph. Eur. Y0001896; traceable to USP 1491004
• API family: oxytetracycline
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -10 to -25°C
• 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

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Oxytetracycline is a broad-spectrum antibiotic which finds a wide use in veterinary medicine because of its potential to inhibit the protein synthesis in gram-positive and gram-negative bacteria. It can be used on animal species like cattle, sheep, goats and pigs.

Application

Oxytetracycline may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and spectrofluorimetry techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

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 secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0364 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

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