• 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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• 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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• 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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• 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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• 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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• 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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• 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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• 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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• 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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• 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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• 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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• 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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