Printed on: Sat Jul 31 2021, 06:11:01 PM Official Status: Currently Official on 31-Jul-2021 DocId: 1_GUID-C47513C9-5E0A-4A6D-87EC-75E112E22EF9_2_en-US

(EST)
Printed by: Le Tran Official Date: Official as of 01-May-2020 Document Type: USP @2021 USPC
1

Calculate the percentage of the labeled amount of

Pseudoephedrine Hydrochloride pseudoephedrine hydrochloride (C10H15NO · HCl) in the
Extended-Release Capsules portion of Capsules taken:
DEFINITION Result = (rU/rS) × (CS/CU) × 100
Pseudoephedrine Hydrochloride Extended-Release Capsules
contain NLT 90.0% and NMT 110.0% of the labeled amount rU = peak response from the Sample solution
of pseudoephedrine hydrochloride (C10H15NO · HCl). rS = peak response from the Standard solution
CS = concentration of USP Pseudoephedrine
IDENTIFICATION
Hydrochloride RS in the Standard solution
Change to read: (mg/mL)
CU = nominal concentration of pseudoephedrine
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared hydrochloride in the Sample solution (mg/mL)
Spectroscopy: 197K▲ (CN 1-May-2020)
Sample: Mix a portion of Capsule contents equivalent to Acceptance criteria: 90.0%–110.0%
180 mg of pseudoephedrine hydrochloride, filter with
10 mL of chloroform, and collect using vacuum filtration. PERFORMANCE TESTS
Maintain the vacuum until no further filtrate can be • DISSOLUTION á711ñ
collected, and evaporate the chloroform on a steam bath, Medium: Water; 900 mL
taking care to avoid overheating. Recrystallize the residue Apparatus 2: 50 rpm
from a small amount of dehydrated alcohol. Times: 3, 6, and 12 h
Acceptance criteria: Meet the requirements Standard solution: USP Pseudoephedrine Hydrochloride RS
of a known concentration similar to that of the Sample

al
• B. The retention time of the major peak of the Sample
solution corresponds to that of the Standard solution, as solution, in Medium
obtained in the Assay. Sample solution: Filtered portion of sample
Analysis
ASSAY Samples: Standard solution and Sample solution
• PROCEDURE
ci Calculate the percentage of the labeled amount of
Mobile phase: Alcohol and 4 mg/mL of ammonium acetate pseudoephedrine hydrochloride (C10H15NO · HCl)
solution (17:3) dissolved, using the Mobile phase and Chromatographic
Standard solution: 1.2 mg/mL of USP Pseudoephedrine system in the Assay.
Hydrochloride RS in alcohol Tolerances: See Table 1.
Sample solution: 1.2 mg/mL of pseudoephedrine
ffi
hydrochloride in 0.01 N hydrochloric acid, prepared by Table 1
transferring an appropriate amount of the contents of NLT Time Amount
20 Capsules to a suitable volumetric flask and dissolving in (h) Dissolved
10% of the flask volume of 0.01 N hydrochloric acid by
3 20%–50%
sonicating for 10 min. Cool to room temperature, dilute
with 0.01 N hydrochloric acid to volume, and filter. 6 45%–75%
O

Chromatographic system
12 NLT 75%
(See Chromatography á621ñ, System Suitability.)
Mode: LC
Detector: UV 254 nm The percentages of the labeled amount of
Column: 4.6-mm × 15-cm; packing L3 pseudoephedrine hydrochloride (C10H15NO · HCl)
Flow rate: 0.7 mL/min dissolved at the times specified conform to Acceptance
Injection volume: 10 µL Table 2 in á711ñ.
System suitability • UNIFORMITY OF DOSAGE UNITS á905ñ: Meet the
Sample: Standard solution requirements
Suitability requirements
Tailing factor: NMT 2.5 ADDITIONAL REQUIREMENTS
Relative standard deviation: NMT 2.0% • PACKAGING AND STORAGE: Preserve in tight containers.
Analysis • USP REFERENCE STANDARDS á11ñ
Samples: Standard solution and Sample solution USP Pseudoephedrine Hydrochloride RS

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