API Oxytetracycline Hydrochloride

Oxytetracycline Hydrochloride More Info

Product Overview

Oxytetracycline Hydrochloride is a salt prepared from oxytetracycline, taking advantage of the basic dimethylamino group which protonates readily to form the salt in hydrochloric acid solutions. It is the hydrochloride salt form commonly used in pharmaceutical preparations.

Chemical Specifications

Oxytetracycline Hydrochloride has a CAS number of 2058-46-0. Its chemical formula is C₂₂H₂₄N₂O₉·HCl or C₂₂H₂₅ClN₂O₉. The molecular weight ranges from 496.89 to 496.90. The substance appears as a yellow, crystalline powder that is odourless and hygroscopic.

Physical Properties

The substance has a melting point of 180°C. Its density is 1.51 g/mL. Oxytetracycline Hydrochloride is freely soluble in water and sparingly soluble in ethanol. The powder is hygroscopic and should be stored properly. Aqueous solutions remain stable at neutral pH; concentrated solutions may hydrolyze and precipitate. The compound is sensitive to light and may degrade when exposed.

Pharmaceutical Classification

Oxytetracycline Hydrochloride belongs to the class of tetracycline antibiotics. It is classified as a second-generation tetracycline antibiotic. It has broad-spectrum activity with antibacterial and anti-protozoal properties.

Antibacterial Spectrum

Oxytetracycline Hydrochloride is active against a wide variety of bacteria including Gram-positive bacteriaand Gram-negative bacteria. It is also effective against Chlamydia, Mycoplasma, Rickettsiae, Haemophilus influenzae, Pasteurella pestis, and Escherichia coli.

Applications

Oxytetracycline Hydrochloride is used to treat infections caused by susceptible bacteria. It has clinical applications for treating bacterial infections including pneumonia and other diseases. In research, it is used in studies of oxytetracycline resistance genes (otrA). It is also used for antibiotic susceptibility testing for Mycoplasma bovis. Clinical microbiology laboratories utilize it for antimicrobial susceptibility testing. In plant pathology, it is used for the prevention of fire blight in apples and pears.

Quality Standards

According to pharmacopoeial specifications, the content should be 95.0% to 110.0% or 95.0% to 102.0% C₂₂H₂₄N₂O₉·HCl, calculated on anhydrous basis. The pH range should be 2.3 to 2.9. Specific rotation should be -180° to -200°. Specific absorption should be 270 to 290 at wavelength 353 nm. Impurity limit by HPLC should be no more than 3.5%.

Production Source

Oxytetracycline Hydrochloride is produced by fermentation of certain strains of Streptomyces rimosus or by other synthetic methods. It was originally discovered by Pfizer Laboratory in 1950 from soil samples.

Storage and Handling

The substance should be preserved in tight, light-resistant containers. Recommended storage temperature is 0-6°C or a cool, dry place. Packaging is available as sealed bags or drums with options of 25kg/Bag and 25kg/Drum. The shelf life is 3 years in the original package.

Safety Information

Handling Oxytetracycline Hydrochloride requires a caution level with protective equipment. The substance may cause serious eye irritation and reproductive toxicity. Protective gloves and eyewear should be used; contact with skin, eyes, and respiratory system should be avoided. The substance should not be disposed in drains or water systems.

Available Forms

Oxytetracycline Hydrochloride is available as pharmaceutical tablets and capsules. Soluble powder is available for veterinary use. Reference standards in EP and USP grades are also available.