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Veterinary
API's

Antimicrobials

Antimicrobials are used in the treatment and prevention of bacterial infection. They may either kill or inhibit the growth of bacteria.

Amoxycillin Trihydrate Powder

  • Appearance: A white or almost white crystalline powder
  • Identification: Examine by IR absorption spectrophotometry comparing with the spectrum obtained with Amoxicillin Trihydrate CRS.
  • Ph (acidity): 3.5 to 5.5
  • Specific optical rotation: +290 to +315
  • Any specified impurity: NMT 1.0 % Any unspecified impurity: NMT 0.10 %
  • Total impurities: NMT 3.0 %
  • N,N-Dimethylaniline: NMT 20 ppm (not used in process)
  • Water: 11,5 % to 14.5 %
  • Sulphated ash: NMT 1.0%
  • Assay: 95.0 % to 102,0 % ,C16H19O5S, calculated on anhydrous basis
  • Residual solvents: a) Acetone: NMT 800 ppm - b) Dichloromethane: NMT 600 ppm - c) Triethylamine: NMT 300 ppm - d) N,N-dimethylacetamide: NMT 1090 ppm - e) Toluene: NMT 600 ppm - f) Pivalic acid: NMT 1000 ppm
  • Bulk density: 0.15 - 0.23 g/ml
  • Microbial Limit: NMT 1000 bacteria per gram - NMT 80 molds and yeasts per gram - E. coli should be undetectable in 1 gram

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Ampicillin Trihydrate Powder

  • Appearance: A white or almost white crystalline powder
  • Identification: A. The IR spectrum obtained with the substance to be examined. Corresponds with that obtained with reference standard. - B. Should meet the requirement under water.
  • Appearance solution: Not more opalescent than reference suspension II (1 mol/L HCL solution) - ≤ reference suspension II (2 mol/L ammonia)
  • PH: 3.5 ~ 5.5
  • Specific optical rotation: + 280 ~ + 305 (calculated on the anhydrous basis)
  • Related substances: Any specified impurity ≤ 1.0 % - Any unspecified impurity ≤ 0.2 % - Total impurities ≤ 3.0 %
  • N,N-Dimethylaniline: NMT 20 ppm (not used in process)
  • Water: 12.0 % ~ 15.0 %
  • Sulphated ash: ≤ 0.5 %
  • Assay: 96.0 % ~ 102.0 % - C16H19N3O4S (calculated on anhydrous basis)
  • Residual solvents: a) Methylene Chloride: NMT 600 ppm - b) Triethylamine: NMT 300 ppm - c) Pivalic Acid: NMT 1000 ppm - d) Acetone: NMT 800 ppm
  • Bulk density: 0.15 ~ 0.40 g/ml

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Chlortetracycline 15 % Granular

  • Appearance: Brown granule, not lumpy or moldy, no unpleasant odor
  • Identification: Positive
  • pH value: 5.0 – 7.5
  • Loss on drying: ≤ 6.5 %
  • Heavy metals: ≤ 20 ppm
  • Arsenic:≤ 2 ppm
  • Particle Size: ≥ 90 % between 20 ~ 60 mesh sieve
  • Active content: 100.0 % ~ 110.0 % of labeled content
  • Epi-CTC/CTC: ≤ 6.0 %
  • TC/CTC: ≥ 8.0 %

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Chlortetracycline 15 % Powder

  • Appearance: Brown to dark brown powder, not lumpy nor moldy, odourless
  • Identification: Positive
  • pH value: 5.0 – 7.5
  • Loss on drying: ≤ 7.0 %
  • Heavy metals: ≤ 20 ppm
  • Arsenic: ≤ 2 ppm
  • Granular Size: All pass through No.2 sieve
  • Potency: ≥ 15.00 %

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Chlortetracycline HCL

  • Appearance: Yellow powder
  • Identification (First identification: C,D - Second identification: A,B,C): A thin-layer Chromatography, B as description of EP8.0,C - Reaction of chlorides, D HPLC identification
  • pH value: 2.3  ~  3.3
  • Specific rotation: -235° ~  -250°
  • Absorbance: ≤ 0.40
  • Heavy metals: ≤ 50 ppm
  • Water: ≤ 2.0 %
  • Sulphated Ash: ≤ 0.5 %
  • Related substances: Impurity A ≤ 4.0 % - Impurity B ≤ 1.0 % - Impurity E ≤ 1.0 % - Impurity J ≤ 0.3 % - Impurity D ≤ 0.2 % - Impurity G ≤ 0.2 % - Impurity H ≤ 0.2 % - Impurity L ≤ 0.2 % - Impurity K ≤ 0.15 %
  • Unspecified impurities: ≤ -.10 %
  • Sum of impurities other than A: ≤ 2.0 %
  • Assay: CTC.HCI (anhydrous substance): ≥ 89.5 % - TC.HCI (anhydrous substance): ≤   6.0 % - CTC.HCI+TC.HCI (anhydrous substance): 94,5 %  ~  102.0 %

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Colistin Sulphate

  • Appearance: White or almost white powder
  • Identification: Conforms to EP specifications
  • Ca²͙͙+ Reachtion(b): Meets the requirements
  • Loss on drying: ≤ 3.5 %
  • pH: 4.0 ~ 6.0
  • Specific optical rotation: -63° ~ -73°
  • Sulphate Ash: ≤ 1.0 %
  • Sulphate: 16.0 ~ 18.0 %
  • Content (Dry Basis HPLC): Colistin E1 –I: ≤ 10.0 % - Colistin E1-7MOA: ≤ 10.0 % - Colistin E3: ≤ 10.0 % -E1+E2+E3+E1 –I +E1-7MOA: ≥ 77.0 % - RRTO.27:: ≤   3.0 %
  • Related substances: RRTO.44:: ≤   3.0 % - RRTO 49: ≤   3.0 % - RRTO 67: ≤   3.0 % - RRTO 93: ≤   3.0 % - (Any impurity): ≤   2.0 % - (Total impurity): ≤ 18.0 %
  • Potency (Dried basis) : ≤ 19000 IU/mg

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Dihydrostreptomycin Sulphate

  • Characters: a white or almost white powder, freely soluble in water, practically insoluble in acetone, in alcohol and in methanol. It may be hygroscopic.
  • Identification: A. The retention time of a major peak meets the Requirements. - E. Positive
  • Appearance of solution: Colour: not more intensely coloured than 5 - Clarity: not more opalescent than II
  • pH: 5.0 – 7.0
  • Specific optical rotation: -83.0° - -91.0°
  • Related substances: Impurity A: NMT 1.0 % - Impurity B: NMT 1.0 % - Impurity C: NMT 2.0 % - Any other impurity: NMT 1.0 % - Total of impurities: NMT 5.0 %
  • Heavy metals: NMT 20 ppm
  • Loss on drying: NMT 5.0 %
  • Sulfated ash: NMT 1.0 %
  • Bacterial endotoxins: less than 0.50 IU/mg
  • Abnormal toxicity: meets the requirements
  • Content (HPLC): sum of Dihydrostreptomycin Sulfate and Streptomycin - Sulfate: 95.0 % - 102.0 % -Streptomycin Sulfate: NMT 2.0 % (dried substances)
  • Sodium Metabisulfite limit: NMT 0.4 % (internal)
  • Potency: NLT 730 IU/mg (dried substances)

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Dihydrostreptomycin Sulphate Sterile

  • Characters: a white or almost white powder, freely soluble in water, practically insoluble in acetone, in alcohol and in
  • methanol. It may be hygroscopic.
  • Identification: A. The retention time of a major peak meets the Requirements. - E. Positive
  • Appearance of solution: Colour: not more intensely coloured than 5 - Clarity: not more opalescent than II
  • pH: 5.0 – 7.0
  • Specific optical rotation: -83.0° - -91.0°
  • Related substances: Impurity A: NMT 1.0 % - Impurity B: NMT 1.0 % - Impurity C: NMT 2.0 % - Any other impurity: NMT 1.0 % - Total of impurities: NMT 5.0 %
  • Heavy metals: NMT 20 ppm
  • Loss on drying: NMT 5.0 %
  • Sulfated ash: NMT 1.0 %
  • Bacterial endotoxins: less than 0.50 IU/mg
  • Abnormal toxicity: meets the requirements
  • Content (HPLC): sum of Dihydrostreptomycin Sulfate and Streptomycin - Sulfate: 95.0 % - 102.0 % - Streptomycin Sulfate: NMT 2.0 % (dried substances)
  • Sodium Metabisulfite limit: NMT 0.4 % (internal)
  • Potency: NLT 730 IU/mg (dried substances)
  • Bacterial endotoxins: less than 0.50 IU/mg
  • Sterility: meets the requirements

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Doxycycline Hyclate

  • Appearance: yellow crystalline powder
  • Identification: A)  HPLC test – corresponds - B)  Sulphuric Acid yellow colour reaction – corresponds - C) Chloride’s reaction – corresponds
  • pH: 2.0 to 3.0
  • Specific optical rotation: -105° to -120°, calculated on the anhydrous, Ethanol-free substance
  • Specific absorbance: 300-335 at 349 nm, calculated on the anhydrous, ethanol-free substance
  • Light-absorbing impurities: NMT 0.07 at 490 nm, calculated on the anhydrous, Ethanol-free substance
  • Related substances (%):  Metacycline: NMT 2.0 % -  6-Epidoxycycline: NMT 2.0 % - Oxytetracycline: NMT 0.5 % -  4-Epidoxycycline: NMT 0.5 % -  4,6-Epidoxycycline: NMT 0.5 % - Impurity F: NMT 0.5 % -  Any other impurities: NMT 0.5 %
  • Ethanol: 4.3 to 6.0 %
  • Heavy metals (ppm): less than 50 ppm
  • Water: 1.4 to 2.8 %
  • Sulphated ash: NMT 0.4 %
  • Assay: 95.0 – 102.0 % of C22H25CIN2O8, calculated on the Anhydrous, ethanol-free substance

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Enrofloxacin Base

  • Appearance: Slightly yellow or pale orange yellow crystalline powder, odorless, slightly bitter; becoming orange-red on exposure to light.
  • Solubility: Freely soluble in chloroform, sparingly soluble in Dimethyl-Formamide, slightly soluble in Methanol, and in Sodium Hydroxide TS, very slightly soluble in water.
  • Melting rage: 221 – 226°C
  • Identification: 1) HPLC: the retention time of the major peak of the sample solution corresponds to the reference - 2) IR: conforms to the reference spectrum
  • Clarify of solution: Clear (1 g/20 ml IN 0.l5 mol/L NaOH solution)
  • Colour of solution: Not more intensely coloured than Y4 or GY4 (1 g/20 ml IN 0.5 mol/L NaOH solution)
  • Fluoroquinolonic Acid: ≤ 0.2 %
  • Related substances: 1) Ciprofloxacin ≤ 0.5 % - 2) Any other single impurity ≤ 0,3 % - 3) total impurities ≤ 0.7 %
  • Loss on drying: ≤ 0.5 %
  • Residue on ignition: ≤ 0.2 %
  • Heavy metals: ≤ 20 ppm
  • Assay: ≥ 99.0 % (dried substance)

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Erythromycin Thiocyanate

  • Description: white or kind of white crystals or crystalline powder; odorless, bitter taste: slightly hygroscopicity.
  • Solubility: freely soluble in Methanol and Ethanol; slightly soluble in Water or Chloroform
  • Identification: 1) positive - 2) positive - 3) positive
  • Loss on drying: ≤ 6.0 %
  • Residue on ignition:≤ 1.0 %
  • Potency: ≥ 750 u/mg (dry)

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Florfenicol

  • Appearance: White or almost white powder or crystalline powder
  • Solubility: Very soluble in Dimethylformamide, soluble in Methanol, sparingly soluble in glacial Acetic Acid, very slightly soluble in water or in Chloroform
  • Identification: A) Infrared absorption – the IR spectrum is in accordance with the spectrum obtained with Florfenicol RS. - B) the retention time of the major peak in the chromatogram of the sample preparation corresponds to that of the standard preparation, as obtained in the assay.
  • Loss on drying: NMT 0.5 %
  • Specific optical rotation: -16° to -19°
  • Melting point: 152 - 156°C
  • pH: 4.5 – 7.0
  • Chlorides: NMT 0.02 %
  • Sulphated ash: NMT 0.1 %
  • Heavy metals: NMT 20 ppm
  • Related substances: max. single impurity – NMT 0.5 % - Total impurities – NMT 2.0 %
  • Assay: not less than 98.0 % (calculated on dried basis)

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Gentamycin Sulphate Sterile

  • Characters: a white or almost white powder, freely soluble in water, practically insoluble in alcohol and in ether.
  • Identification: tests according to monograph
  • Appearance of solution: clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate colour.
  • pH: 3.5 to 5.5
  • Specific optical rotation: +107° to +121°
  • Methanol: NMT 1.0 %
  • Composition: C1 – 25.0 to 50.0 % - C1A: 10.0 to 35.0 % - C2A + C2: 25.0 to 55.0 %
  • Water: NMT 15.0 %
  • Sulphated ash: NMT 1.0 %
  • Sulphate: 32.0 to 35.0 %
  • Sterility: complies with the test for sterility
  • Bacterial endotoxins: less than 1.67 IU/mg
  • Assay: not less than 590 IU/mg (anhydrous substance)

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Lincomycin Hydrochloride

  • Appearance: A white or almost white crystalline powder
  • Identification: The IR spectrum conforms to that obtained with the reference substance
  • Ph (acidity): 3.0 to 5.5
  • Specific optical rotation: +135 to +150
  • Water: 3,0 % to 6.0 %
  • Assay: Not less than 790 u g of Lincomycin (C18H34N2O6S) per mg Bulk density: 0.15 - 0.23 g/ml
  • Bacterial endotoxins: Less than 0.5 IU/mg
  • Residual Solvents: n-Butanol: Not more than 5000 ppm - Octanol: Not more than 2 ppm

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Neomycin Sulphate

  • Characteristics: a white or yellowish-white powder. Odorless or almost. Hygroscopic.
  • Identification: A, B, C – positive reaction
  • Acidity or alkalinity: 5.0 – 7.5
  • Loss on drying: ≤ 8.0 %
  • Assay: ≥ 600 µg/mg (dry)

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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 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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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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Penicillin G Benzathine

  • Appearance: white or almost white powder
  • Solubility: meets the requirements
  • Identification: meets the requirements
  • Related substances: impurity C: ≤ 2 % - any other impurity: ≤ 1 %
  • Water: 5.0 % - 8.0 %
  • Acidity or alkalinity: meets the requirements
  • Content of Benzathine: 24.0 % - 27.0 % Content of Benzathine - Benzylpenicillin: 96.0 % - 102.0 %
  • Sterility: meets the requirements
  • Bacterial endotoxins: < 0.13 IU/ml
  • Residual solvents: Ethyl acetate: ≤ 5000 ppm - Methanol: ≤ 3000 ppm

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Penicillin G Potassium (Benzylpenicillin Potassium)

  • Characters: white or practically white crystalline powder
  • Solubility: very soluble in water, practically insoluble in fatty oils and in liquid paraffin
  • Identification: meets the requirements
  • pH: 5.5 – 7.5
  • Absorbance: at 280 nm: < 0.10 - at 264 nm: 0.80 – 0.88 - at 325 nm: < 0.10
  • Loss on drying: 1.0 %
  • Specific optical rotation: +270° - +300°
  • Content of Penicillin G Potassium: 96.0 % - 102.0 %
  • Related substances: ≤ 1.0 %
  • Sterility: sterile
  • Bacterial endotoxins: < 0.16 IU/mg
  • Residual solvents: Ethyl acetate: ≤ 5000 ppm - Butanol: ≤ 5000 ppm

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Penicillin G Procaine

  • Characters: white or practically white crystalline powder
  • Identification: meets the requirements
  • pH: 5.0 – 7.5
  • Related substances: 4-aminobenzoic acid NMT 0.024 % - any other impurity NMT 1 %
  • Specific optical rotation: +165° - +180°
  • Water: 2.8 % - 4.2 %
  • Bacterial endotoxins: less than 0.10 IU/mg
  • Residual solvent (N-Butanol): ≤ 5000 ppm
  • Sterility: meets the requirements
  • Procaine Benzylpenicillin (anhydrous substance): 96.0 % - 102.0 %
  • Procaine (anhydrous substance): 39.0 % - 42.0 %

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Penicillin G Sodium

  • Characters: white or practically white crystalline powder
  • Solubility: very soluble in water, practically insoluble in fatty oils and in liquid paraffin
  • Identification: meets the requirements
  • pH: 5.5 – 7.5
  • Absorbance: at 280 nm: < 0.10 - at 264 nm: 0.80 – 0.88 - at 325 nm: < 0.10
  • Loss on drying: ≤ 1.0 %
  • Specific optical rotation: +285° - +310°
  • Content of Penicillin G Potassium: 96.0 % - 102.0 %
  • Related substances: ≤ 1.0 % Sterility: sterile
  • Bacterial endotoxins: < 0.16 IU/mg
  • Residual solvents: Ethyl acetate: ≤ 5000 ppm - Butanol: ≤ 5000 ppm

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Streptomycin Sulphate Oral

  • Characters: a white or almost white powder, hygroscopic, very soluble in water, practically insoluble in ethanol
  • Identification: A. TLC-test: principal spot should be as per ref. standard - B. Reaction with ferric chloride: violet colour develops - C. Reaction with sodium hypochlorite: red colour develops - D. Reaction with hydrochloric acid: faint yellow colour develops - D. Reaction of sulphate
  • Appearance of solution: Colour: not more intense than ref. sol 3 - Clarity: not more opalescent than ref. suspension II
  • pH: 4.5 to 7.0
  • Methanol: NMT 0.3 %
  • Streptomycin B: NMT 3.0 %
  • Loss on drying: NMT 7.0 %
  • Sulphated ash: NMT 1.0 %
  • Sulphate: 18.0 % to 21.5 %
  • Colorimetric test: NLT 90.0 %
  • Bacterial endotoxins: less than 0.25 IU/mg
  • Abnormal toxicity: complies
  • Sterility: complies

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Streptomycin Sulphate Sterile

  • Characters: a white or almost white powder, hygroscopic, very soluble in water, practically insoluble in ethanol
  • Identification: A. TLC-test: principal spot should be as per ref. standard - B. Reaction with ferric chloride: violet colour develops - C. Reaction with sodium hypochlorite: red colour develops - D. Reaction with hydrochloric acid: faint yellow colour develops - D. Reaction of sulphate
  • Appearance of solution: Colour: not more intense than ref. sol 3 - Clarity: not more opalescent than ref. suspension II
  • pH: 4.5 to 7.0
  • Methanol: NMT 0.3 %
  • Streptomycin B: NMT 3.0 %
  • Loss on drying: NMT 7.0 %
  • Sulphated ash: NMT 1.0 %
  • Sulphate: 18.0 % to 21.5 %
  • Colorimetric test: NLT 90.0 %
  • Bacterial endotoxins: less than 0.25 IU/mg
  • Abnormal toxicity: complies
  • Sterility: complies
  • Assay (dried potency): NLT 720 IU/mg

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Tilmicosin Phosphate

  • Description: white to yellow powder
  • Identification: Chromatogram – complies Infrared spectrum – complies
  • Water: ≤ 5.0 %
  • pH: 5.0 ~ 6.5
  • Residue on ignition: ≤ 5.0 %
  • Heavy metals: ≤ 20 ppm
  • Cis-isomer: 82.0 – 88.0 %
  • Trans-isomer: 12.0 – 18.0 %
  • Relevance substance: individual substance on dried basis – 1.4 % - total relevance substance on dried basis ≤ 10.0 %
  • Tilmicosin assay dried: ≥ 75.0 %

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Tylosin Tartrate Granular

  • Description: white to buff-coloured granular
  • Solubility: freely soluble in chloroform; soluble in water or methanol; insoluble in ether
  • Identification: positive, chromatogram
  • pH: 5.0 – 7.2
  • Loss on drying: ≤ 4.5 %
  • Residue on ignition: ≤ 2.5 %
  • Heavy metals: ≤ 20 ppm
  • Tyramine: ≤ 0.35 %
  • Granular size: Granule uniformity between 850-125 µm ≥ 85 %
  • Tylosin compositions: Tylosin A ≥ 80 % - A+B+C+D ≥ 95 %
  • Potency: ≥ 800 u/mg (dry)

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Tylosin Tartrate Powder

  • Description: white to pale yellow powder
  • Solubility: freely soluble in chloroform; soluble in water or methanol; insoluble in ether
  • Identification: positive, chromatogram
  • pH: 5.0 – 7.2
  • Loss on drying: ≤ 4.5 %
  • Residue on ignition: ≤ 2.5 %
  • Heavy metals: ≤ 20 ppm
  • Tyramine: absorption of sample solution is NMT the control solution
  • Tylosin compositions: Tylosin A ≥ 80 % - A+B+C+D ≥ 95 %
  • Potency: ≥ 800 u/mg (dry)

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  • GMP+