Oxytetracycline

Aspect: Yellow, crystalline powder.
Formula: C₂₂H₂₄N₂O₉ · 2H₂O · 2H₂O
Identification: A.：Thin-layer chromatogram meets the requirements - B.：Positive - C.：Positive
pH: 4.5 – 7.5
Specific optical rotation: -203° – -216°
Absorbance（353nm): 290-310
Light-absorbing impurities: 430nm: NMT 0.25 - 490nm: NMT 0.20
Related substances: Impurity A: 4-epioxytetracycline NMT 0.5 % - Impurity B: Tetracycline NMT 2.0 % - Impurity C: Other substances NMT 2.0 %
Heavy metals: NMT 50ppm
Water: 6.0 – 9.0 %
Sulfated ash: NMT 0.5 %
Bacterial endotoxins: Less than 0.4 IU/mg (internal)
Assay(HPLC): 95.0-102.0%(anhydrous)
Solubility: Very slightly soluble in water.It dissolves in dilute acid and alkaline solutions.
Expiry Date: Four years after production date
Storage: In an airtight container, protected from light.
Transport information: See our latest safety data sheet
Safety data sheet: Yes
Classified as hazardous as per EU regulation: See our latest safety data sheet

Characters: Appearance – yellow, crystalline powder. - Solubility – very soluble in water. - It dissolves in dilute acid and alkaline solutions.
Identification: A Thin-layer chromatogram - conform - B Positive - C Positive
pH: 4.5 – 7.5
Specific optical rotation: -203° ~ -216°
Absorbance (353 nm): 290 – 310
Light absorbing impurities: 430 nm: NMT 0.25 - 490 nm: NMT 0.20
Related substances: Impurity A: 4-epioxytetracyline NMT 0.5 % - Impurity B: Tetracycline NMT 2.0 % -Impurity C: other substances NMT 2.0 %
Heavy metals: NMT 50 ppm
Water: 6.0 – 9.0 %
Sulfated ash: NMT 0.5 %
Assay (HPLC): 95.0 – 102.0 % (anhydrous)
Bacterial endotoxins: less than 0.4 IU/mg (internal)

Appearance: yellow, crystalline powder, hygroscopic
Solubility: freely soluble in water, sparingly soluble inEthanol (96 %). Solutions in water become turbid on Standing, owing to the precipitation of Oxytetracycline
Identification: A: thin-layer chromatography – complies - B: reaction with sulphuric acid – complies - C: reaction of chlorides – complies
pH: 2.3 to 2.9
Specific optical rotation:-188° to -200°
Specific absorbance (353 nm):270 to 290
Light-absorbing impurities (430 nm): NMT 0.50 - (490 nm): NMT 0.20
Related substances: Impurity A: NMT 0.5 % - Impurity B: NMT 2.0 % - Impurity C: NMT 2.0 % - Any other impurity:NMT 0.1 % - Total impurities D, E, F: NMT 2.0 %
Heavy metals: NMT 50 ppm
Water: NMT 2.0 %
Sulfated ash: NMT 0.5 %
Residual solvent: Methanol – NMT 3000 ppm
Assay (content of C22H25CIN2O9): 95.0 % to 102.0 % (anhydrous substance)

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