Protriptyline Hydrochloride

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₁₉H₂₁N . HCl 299.84

5H-Dibenzo[a,d]cycloheptene-5-propanamine, N-methyl-, hydrochloride;

N-Methyl-5H-dibenzo[a,d]cycloheptene-5-propylamine hydrochloride  CAS RN^®: 1225-55-4; UNII: 44665V00O8.

1 DEFINITION

Protriptyline Hydrochloride contains NLT 99.0% and NMT 101.0% of protriptyline hydrochloride (C₁₉H₂₁N . HCl), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K or (IRA 1-Jan-2025) 197M

B. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U

Analytical wavelength: 292 nm

Sample solution: 10 µg/mL of Protriptyline Hydrochloride in 0.1 N methanolic hydrochloric acid

Acceptance criteria: Absorptivities, calculated on the dried basis, do not differ by more than 3.0%.

Change to read:

C. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Meets the requirements of the test for amine hydrochlorides (IRA 1-Jan-2025)

Change to read:

D. Spectroscopic Identification Tests 〈197〉, X-Ray Powder Diffraction: 197XR (IRA 1-Jan-2025)

Acceptance criteria: Its X-ray diffraction pattern conforms to that of USP Protriptyline Hydrochloride RS.

3 ASSAY

Change to read:

3.1 Procedure

Sample: 700 mg of Protriptyline Hydrochloride

Blank: 30 mL of glacial acetic acid

Titrimetric system

(See Titrimetry 〈541〉.)

Mode: Direct titration

Titrant: 0.1 N perchloric acid VS

Endpoint detection: Visual

Analysis: Transfer the Sample to a 125-mL conical flask, and dissolve in 30 mL of glacial acetic acid. Add crystal violet TS and 10 mL of mercuric acetate TS, and titrate with Titrant to a green endpoint. Perform a blank determination, and make any necessary correction.

Calculate the percentage of protriptyline hydrochloride (C₁₉H₂₁N . HCl) in the Sample taken:

Result = {[(V_S − V_B) × N × F]/W} × 100

V_S = Titrant volume consumed by the Sample (mL)

V_B = Titrant volume consumed by the Blank (mL)

N = actual normality of the Titrant (mEq/mL)

F = equivalency factor, 299.84 mg/mEq

W = Sample weight (mg) (IRA 1-Jan-2025)

Acceptance criteria: 99.0%–101.0% on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

5 SPECIFIC TESTS

5.1 pH 〈791〉

Sample solution: 10 mg/mL of Protriptyline Hydrochloride in water

Acceptance criteria: 5.0–6.5

5.2 Loss on Drying 〈731〉

Analysis: Dry at a pressure not exceeding 5 mm of mercury at 60° to constant weight.

Acceptance criteria: NMT 0.3%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Protriptyline Hydrochloride RS