0.1 M Alcoholic Hydrochloric Acid VS
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Dilute 9.0 mL of hydrochloric acid with aldehyde-free alcohol to 1000 mL.
Standardization
See Volumetric Solutions, 1. Introduction.
See Titrimetry 〈541〉.
Standardize by one of the following procedures. [Note - Other standardization procedures may be used. See Volumetric Solutions, 2. Preparation and Standardization, 2.3 Standardization.]
Standardization with visual endpoint: Accurately weigh about 100 mg of tromethamine, dried according to the label instructions or, if this information is not available, dried at 105° for 3 h. Dissolve in 50 mL of water and add 2 drops of bromocresol green TS. Titrate with the alcoholic hydrochloric acid solution to a pale yellow endpoint.
N= mg tromethamine x (Assay/100) / (121.14 x mL HCl)
where Assay is the content/potency of tromethamine.
Standardization with potentiometric endpoint: Accurately weigh about 100 mg of tromethamine, dried according to the label instructions or, if this information is not available, dried at 105° for 3 h. Dissolve in 10 mL of carbon dioxide-free water and then add 50 mL of alcohol. Titrate with the alcoholic hydrochloric acid solution. Determine the endpoint potentiometrically with a pH electrode suitable for non-aqueous titrations.
N= mg tromethamine x (Assay/100) / (121.14 x mL HCl)where Assay is the content/potency of tromethamine.
[Note - If this volumetric solution is used in a qualitative application such as pH adjustment, dissolution medium, or diluent, its standardization is not required.] (USP 1-Aug-2024)
