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Oxytetracycline HCl

Oxytetracycline HCl

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Packaging Details: 25 kg/drum
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PRODUCT NAME: Oxytetracycline HCl
CAS NUMBER: 2058-46-0

MP 180°C
storage temp.
Water Solubility >100 g/L
General Description Odorless fluffy yellow solid or yellow powder. Bitter taste.
Air & Water Reactions Oxytetracycline hydrochloride is hygroscopic. Water soluble. Undergoes slow hydrolysis in the presence of water. Concentrated aqueous solutions at neutral pH hydrolyze on standing.
Reactivity Profile Oxytetracycline hydrochloride is sensitive to light. Oxytetracycline hydrochloride may be unstable at temperatures above 77° F. Oxytetracycline hydrochloride darkens on exposure to sunlight or to moist air above 194° F. Concentrated aqueous solutions at neutral pH hydrolyze on standing. Oxytetracycline hydrochloride undergoes hydrolysis in the presence of water. Oxytetracycline hydrochloride may be incompatible with alkalis.
Fire Hazard Flash point data for Oxytetracycline hydrochloride are not available. Oxytetracycline hydrochloride is probably combustible.
Usage 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. The hydrochloride is the preferred formulation for pharmaceutical applications. Like all tetracyclines, oxytetracycline shows broad spectrum antibacterial and antiprotozoan activity and acts by binding to the 30S and 50S ribosomal sub-units, blocking protein synthesis.
Antibiotic substance isolated from the elaboration products of the actinomycete, Streptomyces rimosus, grown on a suitable medium. Antibacterial
Item Specification Result
Description Yellow crystalline powder Conforms
Identification a) TLC testformed
b) Color reaction with sulfuric acid          
c) Chloride reaction with silver nitrate
PH 2.3-2.9 2.49
Specific optical rotation Between –188° and –200° -193º
Absorbance: (353nm,E1%, 1cm) Between 270 and 290 275
Light absorbing impurity a) The absorbance at 430nm should not be greater than 0.50 
b) The absorbance at 490nm should not be greater than 0.20
less than10

Related substances a) 4-epioxytetracycline≤0.5%   
b) Tetracycline:≤2.0%
c) Total mixture of α,ß–apo-oxytetracycline ≤2.0%
d) Peak on the tail of the main peak:2.0%
less than0.05

Heavy metals Not more than 50ppm less than 1
Suphated ash Not more than 0.5% 0.01
Water Not more than 2.0% 30.62
Endotoxin Not more than 0.4I.E./mg 12.09
Assay Between 95.0% and 100.5% based on anhydrous substance less than 10

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