Published on USP Medicines Compendium (https://mc.usp.

org)

Eflornithine Topical Cream

Final Authorized Version 1.0
DEFINITION
Eflornithine Topical Cream contains NLT 95.0% and NMT 105.0% of the labeled amount of eflornithine hydrochloride (C6H12F2N2O2 HCl).

Performance-Based Monograph
(Contains tests, procedures, and acceptance criteria for the material under test. It also includes the criteria-based procedures that
define the equivalence criteria necessary to demonstrate that an Acceptable Procedure is equivalent to the Reference Procedures.)
IDENTIFICATION
A. The response of eflornithine hydrochloride from the Sample solution corresponds to that of the Standard solution, as obtained in
the Assay.
ASSAY
PROCEDURE
Standard solution: MC Eflornithine Hydrochloride CRM in an appropriate diluent
Sample solution: Dilute an aliquot of Topical Cream in an appropriate diluent to obtain a concentration approximately the same as
that of the Standard solution.
Analytical system: Use a procedure validated as described in the MC general chapter Assessing Validation Parameters for
Reference and Acceptable Procedures <10>.
System performance requirements
Precision: Meets the requirements for 97.0%103.0%
Accuracy: Meets the requirements for 97.0%103.0%
Specificity: Meets the requirements
Range: Meets the requirements
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of eflornithine hydrochloride in the Sample solution. [NOTEIf the procedure
that is used separately quantifies the eflornithine enantiomers, the calculation of content should be based on their sum.]
Result = (rU/rS) (CS/CU) 100
rU

= peak response from the Sample solution

rS

= peak response from the Standard solution

CS

= concentration of MC Eflornithine Hydrochloride CRM in the Standard solution

CU

= nominal concentration of eflornithine hydrochloride in the Sample solution

Acceptance criteria: 95.0%105.0%

IMPURITIES
ELEMENTAL IMPURITIES <232>: Meets the requirements
RESIDUAL SOLVENTS <467>: Meets the requirements
ORGANIC IMPURITIES
Standard solution: MC Eflornithine Hydrochloride CRM and all appropriate MC Impurity RMs, at concentrations corresponding to the
Acceptance criteria of the impurity, in an appropriate diluent
Sample solution: Dilute or extract an aliquot of Topical Cream in an appropriate diluent to obtain a concentration approximately the
same as that of the Standard solution.
Analytical system: Use a procedure validated as described in MC general chapter Assessing Validation Parameters for Reference
and Acceptable Procedures <10>.
System performance requirements
Precision: Meets the requirements
Accuracy: Meets the requirements

Specificity: Meets the requirements

Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of each impurity in the Sample solution. [NOTEIf the procedure that is used separately quantifies the
eflornithine enantiomers, the calculation of impurity content should be compared to their sum.]
Result = (rU/rS) (CS/CU) 100
rU

= peak response of each impurity from the Sample solution

rS = peak response of each Impurity RM from the Standard solution. [NOTEIf no Impurity RMs are available, use
the peak response of eflornithine.]
CS

= concentration of the standard material in the Standard solution

CU

= nominal concentration of eflornithine hydrochloride in the Sample solution

Acceptance criteria
Any individual impurity: NMT 0.15%
Total impurities: NMT 2.0%
PERFORMANCE TESTS
MINIMUM FILL <755>: Meets the requirements
ADDITIONAL REQUIREMENTS
REFERENCE STANDARDS <11>
MC Eflornithine Hydrochloride CRM
REFERENCE PROCEDURES
(This section provides detailed descriptions of procedures that may be used for the evaluation of the material under test. These
procedures have been fully validated and the data is available on the MC website.)
ASSAY
PROCEDURE
Solution A: 10 mM ammonium acetate in water. Adjust with acetic acid to a pH of 5.3.
Mobile phase: Acetonitrile and Solution A (4:1)
Diluent: Mobile phase
Standard solution: 5.0 mg/mL of MC Eflornithine Hydrochloride CRM in Diluent
Sample solution: Weigh an appropriate quantity of Topical Cream, extract with Diluent, and sonicate for 35 minutes. Dilute with
Diluent, and pass through a 0.45-m filter to obtain a final eflornithine hydrochloride concentration of about 5.0 mg/mL.
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: PDA (scan 200400 nm). [NOTECalculations should be based on the chromatograms collected at 210 nm.]
[NOTETo confirm the absence of co-eluting known and unknown impurity peaks, substitute the detector used below in the test
for Organic Impurities.]
Column: 4.6-mm 25-cm; 5-m packing L1 (similar to Thermo Hypersil Hilic)
Flow rate: 1 mL/min
Injection volume: 20 L
System suitability
Sample: Standard solution
Suitability requirements
Relative standard deviation: NMT 1.0% for the eflornithine hydrochloride peak
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of eflornithine hydrochloride in the portion of Topical Cream taken:
Result = (rU/rS) (CS/CU) 100
rU

= peak response of eflornithine hydrochloride from the Sample solution

rS

= peak response of eflornithine hydrochloride from the Standard solution

CS = concentration of MC Eflornithine Hydrochloride CRM in the Standard solution. [NOTEThe potency of the
Reference Material is included in this term.]
CU = concentration of eflornithine hydrochloride in the Sample solution
IMPURITIES
ORGANIC IMPURITIES
Solution A, Mobile phase, Diluent, Sample solution and Chromatographic system: Proceed as directed in Reference
Procedures, Assay.
Detector: PDA and MS in series.
MS source: ES scan (+ and )
MS conditions
Capillary: 3.00 kv
Cone: 15.0 v
Extractor: 2.0 v
Rf lense: 0.1 v
Source temperature: 80
Desolvation temperature: 450
Standard solution: 5.0 mg/mL of MC Eflornithine Hydrochloride CRM and all appropriate MC Impurity RMs, at concentrations
corresponding to the Acceptance criteria of the impurity in Diluent
System suitability
Sample: Standard solution
Suitability requirements
Relative standard deviation: NMT 1.0% for the eflornithine hydrochloride peak
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of each impurity in the portion of Topical Cream taken: [NOTEWhere an impurity other than those
included in the Standard solution is found in the Sample solution, the peak response and concentration of eflornithine in the
Standard solution is used for the calculation.]
Result = (rU/rS) (CS/CU) 100
rU

= peak response of each impurity from the Sample solution

rS

= peak response of each impurity from the Standard solution.

CS = concentration of each impurity in the Standard solution. [NOTEThe potency of the Reference Material is
included in this term.]
CU = concentration of eflornithine hydrochloride in the Sample solution

Source URL (modified on 2013/01/16 - 1:45pm): https://mc.usp.org/monographs/eflornithine-topical-cream-1-0