Betaine Hydrochloride
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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)
C5H11NO2 · HCl 153.61
Methanaminium, 1-carboxy-N, N, N-trimethyl-, chloride.
Betaine hydrochloride.
(Carboxymethyl)trimethylammonium chloride CAS RN: 590-46-5; UNII: JK8U8K4D6K.
Betaine Hydrochloride contains not less than 98.0 percent and not more than 100.5 percent of C5H11NO2 · HCl, calculated on the anhydrous basis.
Packaging and storage—Preserve in well-closed containers.
USP REFERENCE STANDARDS (11)
USP Betaine Hydrochloride RS
1 Identification
Change to read:
A:Spectroscopic Identification Tests (197), Infrared Spectroscopy: 197K (CN 1-May-2020).
B: A solution (1 in 20) responds to the tests for Chloride (191).
PH (791): between 0.8 and 1.2, in a solution (1 in 4).
WATER DETERMINATION, Method | (921): not more than 0.5%.
RESIDUE ON IGNITION (281): not more than 0.1%.
2 Assay
Transfer about 400 mg of Betaine Hydrochloride, accurately weighed, to a conical flask, add 50 mL of glacial acetic acid, and heat gently with swirling until solution is complete. Add 25 mL of mercuric acetate TS, cool, add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 15.36 mg of C5H11NO2 · HCl.
