Tranylcypromine Tablets

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

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

DOWNLOAD PDF HERE

1 DEFINITION

Tranylcypromine Tablets contain an amount of tranylcypromine sulfate [(C₉H₁₁N)₂ · H₂SO₄] equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of tranylcypromine (C₉H₁₁N).

2 IDENTIFICATION

Change to read:

^▲A._{▲1S (USP41)} The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Add the following:

^▲B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay._{▲1S (USP41)}

3 ASSAY

Change to read:

PROCEDURE

Buffer: Transfer 3.4 g of monobasic ammonium phosphate into a 1-L volumetric flask containing about 900 mL of water. Adjust the solution with phosphoric acid to a pH of 2.2 ± 0.1. Dilute with water to volume, and mix well.

Mobile phase: Methanol and Buffer (30:70)

^▲_{▲(ERR 1-Oct-2018)}

Diluent: Methanol, water, and 0.05 N sulfuric acid ^▲VS _{▲1S (USR41)} (20:60:20)

Standard stock solution: 0.4 mg/mL of USP Tranylcypromine Sulfate RS prepared as follows. Transfer a suitable quantity of USP Tranylcypromine Sulfate RS to a suitable volumetric flask. Add 60% of the flask volume of methanol and 0.05 N sulfuric acid ^▲VS _{▲1S (USR41)} (50:50), sonicate to dissolve, and dilute with Diluent to volume.

Standard solution: 0.04 mg/mL of USP Tranylcypromine Sulfate RS in Diluent, from the Standard stock solution

Sample stock solution: Nominally 0.5 mg/mL of tranylcypromine prepared as follows. Transfer a suitable number of Tablets to an appropriate volumetric flask, add 30% of the flask volume of 0.05 N sulfuric acid ^▲VS _{▲1S (USR41)} and sonicate for 10 min with intermittent shaking. Add 30% of the flask volume of methanol and sonicate for 10 min with intermittent shaking. Shake by mechanical means for 30 min, dilute with Diluent to volume, and mix. Centrifuge a portion of the solution and pass the supernatant through a filter of 0.45-um pore size, discarding the first 2 mL.

Sample solution: Nominally 0.03 mg/mL of tranylcypromine in Diluent, from the Sample stock solution

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 220 nm. ^▲For Identification B, use a diode array detector in the range of 200-400 nm._{▲1S (USR41)}

Column: 4.6-mm x 25-cm; 4-um packing L11

Column temperature: 30°

Flow rate: 1 mL/min

Injection volume: 20 µL

^▲Run time: NLT 2 times the retention time of tranylcypromine_{▲1S (USP41)}

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of tranylcypromine (C₉H₁₁N) in the portion of Tablets taken:

                          Result = (r_U/r_S) × (C_S/C_U) × [M × (M_r1/M_r2)] × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Tranylcypromine Sulfate RS in the Standard solution (mg/mL)

C_U = nominal concentration of tranylcypromine in the Sample solution (mg/mL)

M = number of moles of tranylcypromine per mole of tranylcypromine sulfate, 2

M_r1 = molecular weight of tranylcypromine, 133.19

M_r2 = molecular weight of tranylcypromine sulfate, 364.46

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

Change to read:

4.1 DISSOLUTION (711)

Medium: 0.1 N hydrochloric acid VS: 500 mL, deaerated

Apparatus 1: 100 rpm

Time: 45 min

Buffer: Transfer 6.94 g of sodium perchlorate monohydrate to a 1000-mL volumetric flask containing 900 mL of water and mix until dissolved. Adjust with perchloric acid to a pH of 2.50 and dilute with water to volume.

Mobile phase: Acetonitrile and Buffer (15:85)

Standard stock solution: 0.54 mg/mL of USP Tranylcypromine Sulfate RS in water. [NOTE-Sonicate as needed.]

Standard solution: 0.027 mg/mL of USP Tranylcypromine Sulfate RS in Medium, from the Standard stock solution

Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 3.9-mm x 15-cm; 5-µm packing L1

Column temperature: 35°

Flow rate: 1 mL/min

Injection volume: 50 µL

System suitability

Sample: Standard solution

Suitability requirements

^▲▲_{▲1S (USP41) ▲ (ERR 1-Oct-2018)}

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of tranylcypromine (C₉H₁₁N) dissolved:

                          Result = (r_U/r_S) × C_S × V × [M × (M_r1/M_r2)] × 100 

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution 

C_S = concentration of USP Tranylcypromine Sulfate RS in the Standard solution (mg/mL)

V = volume of Medium, 500 mL

M = number of moles of tranylcypromine per mole of tranylcypromine sulfate, 2

M_r1 = molecular weight of tranylcypromine, 133.19

M_r2 = molecular weight of tranylcypromine sulfate, 364.46 

L = label claim (mg/Tablet)

Tolerances: NLT 75% (Q) of the labeled amount of tranylcypromine (C₉H₁₁N) is dissolved.

4.2 UNIFORMITY OF DOSAGE UNITS (905)

Meet the requirements

5 IMPURITIES

Change to read:

ORGANIC IMPURITIES

Buffer ^▲_{▲1S (USP41)} and Diluent: Prepare as directed in the Assay.

Solution A: Methanol and Buffer (15:85)

Solution B: Methanol and Buffer (30:70)

Mobile phase: See Table 1.

Table 1

Standard stock solution: 70 µg/mL of USP Tranylcypromine Sulfate RS and 280 µg/mL of USP Tranylcypromine Related Compound A RS in Diluent. [NOTE-Sonicate as needed.]

Standard solution: 0.7 µg/mL of USP Tranylcypromine Sulfate RS and 2.8 µg/mL of USP Tranylcypromine Related Compound A RS prepared as follows. Transfer a suitable volume of the Standard stock solution to a suitable volumetric flask, add 30% each of the flask volume of 0.05 N sulfuric acid ^▲VS_{▲1S (USP41)} and methanol, and dilute with Diluent to volume.

Sample solution: Use the Sample stock solution prepared as directed in the Assay.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4.6-mm x 15-cm; 3-µm packing L1

Column temperature: 35°

Flow rate: 1.2 mL/min

Injection volume: 25 µL

System suitability

Sample: Standard solution

Suitability requirements

Resolution: NLT 2.0 between tranylcypromine and tranylcypromine related compound A

Tailing factor: NMT 2.0

Relative standard deviation: NMT 6.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each ^▲degradation product _{▲1S (USP41)} in the portion of Tablets taken:

                          Result = (r_U/r_S) × (C_S/C_U) × [M × (M_r1/M_r2)] × 100

r_U = peak response of the ^▲degradation product _{▲1S (USP41)} from the Sample solution

r_S = peak response from the Standard solution S

C_S = concentration of USP Tranylcypromine Sulfate RS in the Standard solution (mg/mL)

C_U = nominal concentration of tranylcypromine in the Sample solution (mg/mL)

M = number of moles of tranylcypromine per mole of tranylcypromine sulfate, 2

M_r1 = molecular weight of tranylcypromine, 133.19

M_r2 = molecular weight of tranylcypromine sulfate, 364.46

Acceptance criteria

Individual ^▲degradation product: _{▲1S (USP41)} NMT 0.2%

Total ^▲degradation product: _{▲1S (USP41)} NMT 1.2%

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers, and store at controlled room temperature.

USP REFERENCE STANDARDS (11)

USP Tranvicypromine Sulfate RS

USP Tranvicvpromine Related Compound A RS

(±)-cis-2-Phenylcyclopropanamine hydrochloride;

cis-Tranylcypromine hydrochloride.

C₉H₁₁N · HCI              169.65