Raw Material Specification & Method of Analysis (MOA) / Standard Testing Procedure (STP) for Cefuroxime Sodium USP and per USP NF Volume No. PF 41(4).
Specification of Cefuroxime Sodium USP
| Sr. No. | Test Parameter | Specification |
| 1 | Description | White or faintly yellow powder. |
| 2 | Solubility | Freely soluble in water. |
| 3 | Identification :A) By HPLC | The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for cefuroxime, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay. |
| B) Test for Sodium | A dense precipitate is formed. Sodium compounds impart an intense yellow color to a nonluminous flame. | |
| 4 | pH (in a solution 1 in 10) | Between 6.0 and 8.5 |
| 5 | Water | Not more than 3.5% w/w. |
| 8 | Assay (By HPLC) | Not less than 855 µg and not more than 1000 µg of Cefuroxime (C16H16N4O8S), calculated on the anhydrous basis. |
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Analytical Method of Cefuroxime Sodium USP
1.0 Description
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- Carry out the test as per procedure. For detailed Description Test Procedure – Refer GTP – Description / Appearance Test.
2.0 Solubility
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- Carry out the test as per procedure.
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- Freely soluble in boiling water; soluble in water, in alcohol, and in glycerin.
Solubility Table
| Descriptive Term | Parts of Solvent Required for 1 Part of Solute |
| Very soluble | Less than 1 |
| Freely soluble | From 1 to 10 |
| Soluble | From 10 to 30 |
| Sparingly soluble | From 30 to 100 |
| Slightly soluble | From 100 to 1,000 |
| Very slightly soluble | From 1,000 to 10,000 |
| Practically insoluble, or Insoluble | Greater than or equal to 10,000 |
3.0 Identification Test – Cefuroxime Sodium USP
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- Procedure by HPLC
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- The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for cefuroxime, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
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- Test for Sodium : Carry out the test as per procedure.
4.0 pH
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- Weigh accurately 1.0 gm of sample in a 10 ml volumetric flask, dissolve and dilute with purified water up to the mark.
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- Measure the pH of this solution as per respective SOP for Water content determination. Refer detailed procedure for pH value determination.
5.0 Water Content
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- Carry out the test on 400 mg of sample by Method – I as per procedure determination of water content. Refer the GTP – Water Content Determination
6.0 Assay Test – Cefuroxime Sodium USP
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- Procedure : By HPLC
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- pH 3.4 Acetate Buffer : Transfer 50 mL of 0.1 M sodium acetate to a 1000-mL volumetric flask, dilute with 0.1 N acetic acid to volume, and mix.
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- Mobile Phase : Prepare a suitable mixture of pH 3.4 acetate buffer and acetonitrile (about 10 : 1). Filter through a membrane filter (1 µm or finer porosity), and degas.
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- Internal Standard Solution : Prepare a solution of orcinol in water containing 1.5 mg per ml.
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Standard Preparation :
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- Dissolve a suitable quantity of USP Cefuroxime Sodium RS, accurately weighed, in water to obtain a solution having a known concentration of about 1 mg of cefuroxime (C16H16N4O8S) per mL.
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- Immediately transfer 5.0 mL of the resulting solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with water to volume, and mix.
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- This Standard preparation contains about 0.05 mg of cefuroxime per mL.
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Assay Sample Preparation :
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- Using a suitable quantity of Cefuroxime Sodium, accurately weighed, proceed as directed in the first sentence under Standard preparation.
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- Immediately transfer 5.0 mL of the resulting solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with water to volume, and mix.
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Chromatographic System :
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- The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 15-cm column that contains 5-µm packing L15.
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- The flow rate is about 2 mL per minute.
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- Chromatograph the Standard preparation, and record the peak responses as directed under
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- The column efficiency determined from the analyte peak is not less than 1300 theoretical plates.
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- The tailing factor for the analyte peak is not more than 2.0;
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- The resolution, R, between the analyte and internal standard peaks is not less than 3.5; and the relative standard deviation for replicate injections is not more than 2.0%.
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- Procedure :
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- Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
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- The relative retention times are about 0.5 for cefuroxime and 1.0 for orcinol.
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- Calculate the quantity, in µg, of cefuroxime per mg of the Cefuroxime Sodium taken by the formula :
1000 (C/M)( R U / R S)
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- Where
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- C is the concentration, in mg of cefuroxime (C16H16N4O8S) per mL, in the Standard preparation;
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- M is the concentration, in mg per mL, in the Assay preparation based on the weight of Cefuroxime Sodium taken and the extent of dilution; and
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- R U and R S are the peak response ratios of the cefuroxime peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.
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