Amoxicillin
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4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,6-[[amino(4-hydroxyphenyl)acetyl]amino-3,3-dimethyl-7-oxo-,trihydrate 2S-[2a,[5a,6b(S*)]]-.
(2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate [61336-70-7].
Anhydrous 365.41 [26787-78-0].
»Amoxicillin contains not less than 900µg and not more than 1050µg of C16H19N3O5Sper mg,calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight containers,and store at controlled room temperature.
Labeling—
Where it is intended for use in preparing injectable dosage forms,the label states that it is intended for veterinary use only and that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.Label all other Amoxicillin to indicate that it is to be used in the manufacture of nonparenteral drugs only.
Identification,Infrared Absorption á197Kñ.
Crystallinity á695ñ:
meets the requirements.
pHá791ñ:
between 3.5and 6.0,in a solution containing 2mg per mL.
Water,Method Iá921ñ:
between 11.5%and 14.5%.
Dimethylaniline á223ñ:
meets the requirement.
Other requirements—
Where the label states that Amoxicillin is sterile,it meets the requirements for Sterilityand Bacterial endotoxinsunder Amoxicillin for Injectable Suspension.Where the label states that Amoxicillin must be subjected to further processing during the preparation of injectable dosage forms,it meets the requirements for Bacterial endotoxinsunder Amoxicillin for Injectable Suspension.
Assay—
Diluent—
Dissolve 13.6g of monobasic potassium phosphate in 2000mLof water,and adjust with a 45%(w/w)solution of potassium hydroxide to a pHof 5.0±0.1.
Mobile phase—
Prepare a suitable filtered mixture of Diluentand acetonitrile (96:4).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).Decrease the acetonitrile concentration to increase the retention time of amoxicillin.
Standard preparation—
Quantitatively dissolve an accurately weighed quantity of USP Amoxicillin RSin Diluentto obtain a solution having a known concentration of about 1.2mg per mL.Use this solution within 6hours.
Assay preparation—
Transfer about 240mg of Amoxicillin,accurately weighed,to a 200-mLvolumetric flask,dissolve in and dilute with Diluentto volume,and mix.Use this solution within 6hours.
Chromatographic system
(see Chromatography á621ñ)—The liquid chromatograph is equipped with a 230-nm detector and a 4-mm ×25-cm column that contains packing L1.The flow rate is about 1.5mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the capacity factor,k¢,is between 1.1and 2.8,the column efficiency is not less than 1700theoretical plates,the tailing factor is not more than 2.5,and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure—
Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in µg,of C16H19N3O5Sper mg of the Amoxicillin taken by the formula:
200(CP/W)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Amoxicillin RSin the Standard preparation;Pis the stated amoxicillin content,in µg per mg,of USP Amoxicillin RS;Wis the quantity,in mg,of Amoxicillin taken to prepare the Assay preparation;and rUand rSare the amoxicillin peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 143
Phone Number:1-301-816-8335