Printed on: Thu Feb 09 2023, 12:27:05 AM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-B44FA238-D776-44DA-A788-A3A6D08C7291_1_en-US

Printed by: Dang Van Vu Official Date: Official Prior to 2013 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: ew8z5 DOI: https://doi.org/10.31003/USPNF_M84550_01_01
1

Instrumental conditions
Tretinoin Topical Solution Mode: UV
DEFINITION Analytical wavelength: 352 nm
Tretinoin Topical Solution is a solution of Tretinoin in a suitable Cell: 1 cm
nonaqueous, hydrophilic solvent. It contains NLT 90.0% and Blank: Acidified isopropyl alcohol
NMT 135.0% of the labeled amount of tretinoin (C20H28O2) Analysis
Samples: Standard solution and Sample solution
(w/w).
Calculate the percentage of the labeled amount of tretinoin
IDENTIFICATION (C20H28O2) in the portion of Topical Solution taken:
• A.
Sample solution: Mix 5 mL of Topical Solution and 5 mL of Result = (AU/AS) × (CS/CU) × 100
water.
Acceptance criteria: A voluminous yellow precipitate is AU = absorbance of the Sample solution
formed. AS = absorbance of the Standard solution
• B. CS = concentration of USP Tretinoin RS in the Standard
Sample solution: Proceed as directed for the Sample solution (µg/mL)
solution in the Assay. CU = nominal concentration of tretinoin in the Sample
Analysis: Measure the absorbance between 300 and solution (µg/mL)
450 nm.
Acceptance criteria: The Sample solution exhibits maxima Acceptance criteria: 90.0%–135.0%
and minima at the same wavelengths as that of a similar
solution of USP Tretinoin RS, concomitantly measured. OTHER COMPONENTS
• ALCOHOL DETERMINATION á611ñ: 90.0%–110.0% of the

al
ASSAY labeled amount of alcohol (C2H5OH)
• PROCEDURE
Avoid exposure to strong light, and use low-actinic ADDITIONAL REQUIREMENTS
glassware. • PACKAGING AND STORAGE: Preserve in tight, light-resistant
Acidified isopropyl alcohol: Dilute 1 mL of 0.01 N
ci containers.
hydrochloric acid with isopropyl alcohol to make 1000 mL. • USP REFERENCE STANDARDS á11ñ
Standard solution: 3.75 µg/mL of USP Tretinoin RS in USP Tretinoin RS
Acidified isopropyl alcohol
Sample solution: Nominally 3.75 µg/mL of tretinoin in
Acidified isopropyl alcohol from Topical Solution
ffi
O

https://online.uspnf.com/uspnf/document/1_GUID-B44FA238-D776-44DA-A788-A3A6D08C7291_1_en-US 1/1
www.webofpharma.com