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Pharmaceutical
API's

Oxytetracycline

Oxytetracycline Dihydrate

  • 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

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Oxytetracycline Dihydrate (Injectable Grade)

  • 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)

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Oxytetracycline Hydrochloride

  • 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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  • GMP+
  • HACCP