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Eucatropine Hydrochloride Ophthalmic Solution
» Eucatropine Hydrochloride Ophthalmic Solution is a sterile, isotonic, aqueous solution of Eucatropine Hydrochloride. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C17H25NO3·HCl. It may contain suitable antimicrobial agents.
Packaging and storage— Preserve in tight containers.
A: It meets the requirements under Identification—Organic Nitrogenous Bases 181.
B: It responds to the tests for Chloride 191.
Sterility 71: meets the requirements.
pH 791: between 4.0 and 5.0.
Standard preparation— Weigh accurately about 50 mg of USP Eucatropine Hydrochloride RS, dissolve in water, and dilute with water in a volumetric flask to 100 mL. Dilute 10.0 mL of this solution with water to 50.0 mL to obtain a solution having a known concentration of about 100 µg per mL. Prepare this solution fresh.
Assay preparation— Transfer a portion of Ophthalmic Solution, equivalent to 50 mg of eucatropine hydrochloride, to a 100-mL volumetric flask, and dilute with water to volume. Dilute 10.0 mL of this solution with water to 50.0 mL.
Procedure— Transfer duplicate 2-mL portions of the Standard preparation and of the Assay preparation to separate glass-stoppered, 40-mL centrifuge tubes. To one set of two tubes add 3 mL of water and 1 mL of sodium hydroxide solution (1 in 100). Heat these tubes in a boiling water bath for 10 minutes, and allow to cool to room temperature. To the remaining set of tubes, which provide the blanks for the Standard preparation and Assay preparation, respectively, add 4 mL of water. To each tube add 2 mL of approximately 0.2 M ceric sulfate in diluted sulfuric acid (prepared by dissolving 12.6 g of ceric ammonium sulfate in 50 mL of water and 3 mL of sulfuric acid, and diluting with water to 100 mL) and 20.0 mL of isooctane. Shake by mechanical means for 15 minutes, allow the layers to separate, and remove the isooctane from each tube. Concomitantly determine the absorbances of the isooctane solutions from the hydrolyzed aliquots in 1-cm cells at the wavelength of maximum absorbance at about 242 nm, with a suitable spectrophotometer, against the respective blanks. Calculate the quantity, in mg, of C17H25NO3·HCl in the portion of Ophthalmic Solution taken by the formula:
0.5C(AU / AS)
in which C is the concentration, in µg per mL, of USP Eucatropine Hydrochloride RS in the Standard preparation; and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.USP32
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2341
Pharmacopeial Forum: Volume No. 33(6) Page 1168