Atropine Sulfate Tablets
» Atropine Sulfate Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of atropine sulfate [(C17H23NO3)2·H2SO4·H2O].
Packaging and storage— Preserve in well-closed containers.
A: Triturate a quantity of Tablets, equivalent to about 5 mg of atropine sulfate, with 10 mL of water for a few minutes, and filter into a small separator. Render the solution alkaline with 6 N ammonium hydroxide, and extract with 50 mL of chloroform. Filter the chloroform layer, and evaporate to dryness. The residue so obtained meets the requirements under Identification—Organic Nitrogenous Bases 181.
B: A filtered solution of Tablets responds to the tests for Sulfate 191.
Disintegration 701: 15 minutes.
Uniformity of dosage units 905: meet the requirements.
pH 9.0 Buffer, Internal standard solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Atropine Sulfate Ophthalmic Solution.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 1 mg of atropine sulfate, to a separator, and proceed as directed for the Assay preparation in the Assay under Atropine Sulfate Ophthalmic Solution, beginning with “Add 2.0 mL of Internal standard solution.”
Procedure— Proceed as directed in the Assay under Atropine Sulfate Ophthalmic Solution. Calculate the quantity, in mg, of atropine sulfate [(C17H23NO3)2·H2SO4·H2O] in the portion of Tablets taken by the formula:
(694.85 / 676.83)(W / 10)(RU / RS)
in which 694.85 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively; W is the weight, in mg, of USP Atropine Sulfate RS in the Standard preparation; and RU and RS are as defined therein.
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 1606
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.