Drospirenone and Ethinyl Estradiol Tablets. Type of Posting. Revision Bulletin Posting Date. 31 July 2015 Official Date

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1 Drospirenone and Ethinyl Estradiol Tablets Type of Posting Revision Bulletin Posting Date 31 July 2015 Official Date 01 August 2015 Expert Committee MonographsSmall Molecules 4 Reason for Revision Compliance In accordance with the Rules and Procedures of the Council of Experts, the MonographsSmall Molecules 4 Expert Committee has revised the Drospirenone and Ethinyl Estradiol Tablets monograph. The purpose for the revision is to add Dissolution Test 3 for another product approved by the FDA. The liquid chromatographic procedure in the test for Dissolution Test 3 is based on analyses performed with an Inertsil Ph-3 brand of L11 column. The typical retention time for Ethinyl Estradiol and Drospirenone are about 5 min. and 7.5 min., respectively. The Drospirenone and Ethinyl Estradiol Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 39 NF 34. Should you have any questions, please contact Domenick Vicchio, Ph.D. ( or

2 . Samples: Revision Bulletin Official August 1, 2015 Drospirenone 1 Drospirenone and Ethinyl Estradiol Tablets and Sample solution Calculate the percentage of the labeled amount of ethinyl estradiol (C 20H 24O 2) in the portion of Tablets taken: DEFINITION Result = (r U/r S) (C S/C U) 100 Drospirenone and Ethinyl Estradiol Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of dro- r U = peak response of ethinyl estradiol from the spirenone (C 24H 30O 3) and NLT 90.0% and NMT 110.0% Sample solution of the labeled amount of ethinyl estradiol (C 20H 24O 2). r S = peak response of ethinyl estradiol from the IDENTIFICATION C S = concentration of USP Ethinyl Estradiol RS in A. The retention times of the drospirenone and ethinyl the estradiol peaks of the Sample solution correspond to C U = nominal concentration of ethinyl estradiol in those of the, as obtained in the Assay. the Sample solution Acceptance criteria: 90.0% 110.0% of ethinyl es- ASSAY tradiol; 90.0% 110.0% of drospirenone PROCEDURE Solution A: Dissolve 132 g of dibasic ammonium phosphate in 0.8 L of water, adjust with phosphoric acid to PERFORMANCE TESTS a ph of 6.8, and dilute to 1 L. Solution B: Solution A and water (1:24) Change to read: Mobile phase: Acetonitrile and Solution B (1:1). Adjust with phosphoric acid to a ph of 6.8. DISSOLUTION 711 : (L/25) mg/ml of USP Drospirenone Test 1: For drug products labeled to contain 3 mg of RS and USP Ethinyl Estradiol RS in Mobile phase, where drospirenone and 0.03 mg of ethinyl estradiol, or 3 mg L is the Tablet label claim, in mg/tablet, of each of drospirenone and 0.02 mg of ethinyl estradiol compound Sample solution: Transfer 10 Tablets to a 250-mL vol- Apparatus 2: 50 rpm umetric flask, add 230 ml of Mobile phase, and soni- Time: 30 min cate with intermittent shaking for NLT 10 min, or until : (L/900) mg/ml of USP Drospire- the Tablets are completely dispersed. Equilibrate to none RS and USP Ethinyl Estradiol RS in Medium, room temperature. Dilute with Mobile phase to volume, where L is the Tablet label claim of each compound. and centrifuge the sample until a clear supernatant is A volume of methanol not exceeding 2% of the final obtained. Use the supernatant. total volume of solution may be used to aid in dis- solving these compounds. Sample solution: Pass a portion of the solution under test through a suitable cellulose filter of 0.45-µm pore Detector 1: UV 270 nm for drospirenone size, discarding the first 10 ml. Detector 2: Fluorescence, excitation wavelength at Mobile phase: Acetonitrile and water (40:60) 285 nm, emission wavelength at 315 nm for ethinyl estradiol. [NOTEDetector 1 and Detector 2 are con- nected in series.] Column: 4.0-mm 12.5-cm; 3-µm packing L1 Detector: UV 270 nm (for drospirenone), in series Column temperature: 25 ± 3 Flow rate: 1.2 ml/min with excitation at 210 nm and detection at 315 nm, Injection volume: 20 µl or with excitation at 281 nm and detection at 305 System suitability nm Sample: Column: 4.6-mm 6-cm; 3-µm packing L1 Column temperature: 22 Tailing factor: Between 0.8 and 1.8 for both drospi- Flow rate: 1 ml/min renone and ethinyl estradiol Injection volume: 100 µl Relative standard deviation: NMT 2.0% for both System suitability Sample: Analysis Samples: and Sample solution Column efficiency: NLT 2000 for both drospire- Calculate the percentage of the labeled amount of dro- none and ethinyl estradiol spirenone (C 24H 30O 3) in the portion of Tablets taken: Tailing factor: Between 0.8 and 1.5 for both dro- spirenone and ethinyl estradiol Result = (r U/r S) (C S/C U) 100 Relative standard deviation: NMT 3% for both r U = peak response of drospirenone from the Samples: and Sample solution Sample solution [NOTEIn Medium, drospirenone is partially converted r S = peak response of drospirenone from the into 17-epidrospirenone, which has a relative reten- tion time of approximately 1.2 relative to drospire- C S = concentration of USP Drospirenone RS in the none. The amount of drospirenone dissolved is calcu- lated from the sum of drospirenone and 17-epidros- C U = nominal concentration of drospirenone in the pirenone.] Sample solution

3 2 Drospirenone Official August 1, 2015 Apparatus 2: 50 rpm (C 20H 24O 2) dissolved: Time: 30 min Mobile phase: Acetonitrile and water (50:50) Result = (r U/r S) (C S/L) V 100 Standard stock solution A: 2.8 µg/ml of USP Ethinyl Estradiol RS in acetonitrile. Sonicate as needed. r U = peak response from the Sample solution Standard stock solution B: 168 µg/ml of USP Dror S = peak response from the spirenone RS in acetonitrile. Sonicate as neeed. C S = concentration of the : (L/900) mg/ml of USP Drospire- none RS and USP Ethinyl Estradiol RS in Medium from L = label claim (mg/tablet) Standard stock solution A and Standard stock solution B, V = volume of Medium, 900 ml where L is the Tablet label claim of each compound. Tolerances: NLT 85% (Q) of the labeled amount of Sample solution: Pass a portion of the solution under drospirenone and NLT 75% (Q) of the labeled test through a suitable glass filter of 1-µm pore size, amount of ethinyl estradiol is dissolved. discarding the first 5 ml. Test 2: For drug products labeled to contain 3 mg of Mobile phase: Acetonitrile and water (50:50) drospirenone and 0.02 mg of ethinyl estradiol. If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2. Detector: UV 265 nm (for drospirenone), in series Apparatus 2: 50 rpm Time: 30 min with excitation at 285 nm and detection at 310 nm : (L/900) mg/ml of USP Drospire- Column: 4.6-mm 15-cm; 5-µm packing L11 none RS and USP Ethinyl Estradiol RS in Medium, Temperatures where L is the Tablet label claim of each compound. Column: 30 Sample solution: Centrifuge a portion of the solution Autosampler: 10 under test at 3500 rpm for 15 min, and use the Flow rate: 1 ml/min supernatant. Injection volume: 50 µl Mobile phase: Acetonitrile, methanol, and water System suitability (40:5:55) Sample: Tailing factor: NMT 2.0 for both drospirenone and ethinyl estradiol Detector: UV 260 nm (for drospirenone), in series Relative standard deviation: NMT 2.0% for both with excitation at 280 nm and detection at 310 nm Samples: and Sample solution Column: 4.6-mm 10-cm; 3-µm packing L1 Temperatures Column: 30 (C 20H 24O 2) dissolved: Autosampler: 5 Flow rate: 1 ml/min Result = (r U/r S) C S V (1/L) 100 Injection volume: 200 µl System suitability r U = peak response from the Sample solution Sample: r S = peak response from the C S = concentration of the Tailing factor: NMT 2 for both drospirenone and ethinyl estradiol V = volume of Medium, 900 ml Relative standard deviation: NMT 3% for both L = label claim (mg/tablet) Tolerances: NLT 80% (Q) of the labeled amount of Samples: and Sample solution drospirenone and NLT 75% (Q) of the labeled amount of ethinyl estradiol is dissolved. (RB 1-Aug-2015) UNIFORMITY OF DOSAGE UNITS 905 : Meet the (C 20H 24O 2) dissolved: requirements Result = (r U/r S) (C S/L) V 100 IMPURITIES r U = peak response from the Sample solution Change to read: r S = peak response from the C S = concentration of the ORGANIC IMPURITIES Solution A: Acetonitrile, methanol, and water L = label claim (mg/tablet) (26:19:55) V = volume of Medium, 900 ml Solution B: Acetonitrile, methanol, and water Tolerances: NLT 80% (Q) of the labeled amount of (76:19:5) drospirenone and NLT 85% (Q) of the labeled Mobile phase: See Table 1. amount of ethinyl estradiol is dissolved..test 3: For drug products labeled to contain 3 mg of Table 1 drospirenone and 0.03 mg of ethinyl estradiol, or 3 mg of drospirenone and 0.02 mg of ethinyl estradiol. If the Time Flow Solution A Solution B product complies with this test, the labeling indicates (min) (ml/min) (%) (%) that it meets USP Dissolution Test

4 Official August 1, 2015 Drospirenone 3 Table 1 (Continued) Signal-to-noise ratio: NLT 10 for drospirenone and ethinyl estradiol related compound B and NLT 7.0 Time Flow Solution A Solution B for ethinyl estradiol, Sensitivity solution (min) (ml/min) (%) (%) Analysis Samples: and Sample solution Identify the ethinyl estradiol degradation products us ing the relative retention times given in Table 2. Calculate the percentage of each ethinyl estradiol degra dation product and unspecified degradation products System suitability stock solution: (L 1 18/100) in the portion of Tablets taken: µg/ml of USP Drospirenone RS in Solution A, where L 1 is the label claim (µg/tablet) of drospirenone Result = (r U/r S) (C S/C U) (1/F) 100 System suitability solution: Transfer 1.0 ml of the Sysr U = peak response of each ethinyl estradiol tem suitability stock solution into a 10-mL volumetric flask, add 1.0 ml of 0.1 N hydrochloric acid, and heat degradation product from the Sample for 30 min in a 40 water bath. Immediately add 1 ml solution of 0.1 N sodium hydroxide (NaOH) and allow to reach r S = peak response of ethinyl estradiol from the room temperature. Dilute with Solution A to volume to obtain a solution containing drospirenone and C S = concentration of USP Ethinyl Estradiol RS in 17-epidrospirenone. [NOTESodium hydroxide (NaOH) the (µg/ml) must be added immediately after heating for the reacthe C U = nominal concentration of ethinyl estradiol in tion to proceed properly. The drospirenone to 17-epidrospirenone ratio must be between 3:1 and F = relative response factor for each degradation 7:1.] product (see Table 2) : (L 1 15/1000) µg/ml of USP Dro- Samples: and Sample solution spirenone RS, (L 2 30/1000) µg/ml of USP Ethinyl Escompound B in the portion of Tablets taken: Calculate the percentage of ethinyl estradiol related tradiol RS, and (L 2 30/1000) µg/ml of USP Ethinyl Estradiol Related Compound B RS in Solution A, where L 1 and L 2 are the label claim (µg/tablet) of drospirenone and ethinyl estradiol, respectively Result = (r U/r S) (C S/C U) 100 Sensitivity solution: (L r U 1 15/10,000) µg/ml of USP = peak response of ethinyl estradiol related Drospirenone RS, (L 2 30/10,000) µg/ml of USP compound B from the Sample solution Ethinyl Estradiol RS, and (L r S 2 30/10,000) µg/ml of = peak response of ethinyl estradiol related USP Ethinyl Estradiol Related Compound B RS in Solu- compound B from the tion A, where L C S 1 and L 2 are the label claim (µg/tablet) = concentration of USP Ethinyl Estradiol Related of, respectively, pre- Compound B RS in the pared from the (µg/ml) Sample solution: Transfer 15 Tablets to a 10-mL glassthe C U = nominal concentration of ethinyl estradiol in stoppered test tube, and add 5.0 ml of Solution A. Shake vigorously, sonicate for NLT 5 min, and place in Samples: and Sample solution an ice bath for NLT 10 min. Centrifuge the sample at Identify the drospirenone degradation products using least until an almost clear supernatant is obtained. Filthe percentage of each drospirenone degradation the relative retention times given in Table 3. Calculate ter the supernatant, and use the filtrate. product in the portion of Tablets taken: Result = (r U/r S) (C S/C U) (1/F) 100 Detector 1: UV 222 nm r U = peak response of each drospirenone Detector 2: Fluorescence, excitation wavelength at degradation product from the Sample 215 nm, emission wavelength at 315 nm..monitor solution the signal at 344 nm for ethinyl estradiol related com- r S = peak response of drospirenone from the pound B (typically between 37 and 42 min). (ERR 1-Oct- 2014) [NOTEDetector 1 and Detector 2 are connected C S = concentration of USP Drospirenone RS in the in series. Use the response at 344 nm to quantify (µg/ml) ethinyl estradiol related compound B.] C U = nominal concentration of drospirenone in the Column: 3.0-mm 30-cm; 3-µm packing L1 fol- lowed, in series, by a 4.6-mm 10-cm; chromolith F = relative response factor for each degradation packing L1 product (see Table 3) Column temperature: 40 Acceptance criteria Flow rate: See Table 1. [NOTEReport only degradation products greater than Injection volume: 20 µl 0.1%.] System suitability Individual degradation products: See Table 2 for Samples: System suitability solution,, ethinyl estradiol and Table 3 for drospirenone. and Sensitivity solution Total degradation products: NMT 3.5% Tailing Factor: Between 0.8 and 1.5 for both drospi- ADDITIONAL REQUIREMENTS renone and ethinyl estradiol, PACKAGING AND STORAGE: Preserve in well-closed Resolution: NLT 2.0 between drospirenone and containers. 17-epidrospirenone, System suitability solution LABELING: When more than one Dissolution test is given, Relative standard deviation: NMT 5.0% for both the labeling states the Dissolution test used only if Test 1, is not used.

5 4 Drospirenone Official August 1, 2015 Table 2 Relative Relative Acceptance Acceptance Detection Retention Response Criteria, Criteria, Name Mode Time Factor NMT (%) a. NMT (%) b. 6α-Hydroxy ethinyl estradiol c. Fl (215 nm/315 nm) g β-Hydroxy ethinyl estradiol d. Fl (215 nm/315 nm) Keto ethinyl estradiol e. UV 222 nm Ethinyl estradiol related compound B Fl (215 nm/344 nm) f. Ethinyl estradiol Fl (215 nm/315 nm) 1.0 Any unspecified degradation Fl (215 nm/315 nm) product and UV h. Total degradation product a.limits for drug products labeled to contain 3 mg of drospirenone and 0.03 mg of ethinyl estradiol. b.limits for drug products labeled to contain 3 mg of drospirenone and 0.02 mg of ethinyl estradiol. c.19-nor-6α,17α-pregna-1,3,5(10)-trien-20-yne-3,6,17-triol. d.19-nor-6β,17α-pregna-1,3,5(10)-trien-20-yne-3,6,17-triol. e.19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol-6-one. f. 9,11-Ethinyl estradiol. 19-Nor-17α-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol. g. Fl = Fluorescence. h.determine unknown impurities using both modes of detection. Report the values from the detection mode that yield higher impurity levels. Table 3 Detection Relative Relative Acceptance Acceptance Mode Retention Response Criteria, Criteria, Name (λ nm) Time Factor NMT (%) a. NMT (%) b. Drospirenone UV Epidrospirenone c. UV Ethinyl estradiol UV Any unspecified degradation product UV Total degradation product a.limits for drug products labeled to contain 3 mg of drospirenone and 0.03 mg of ethinyl estradiol. b.limits for drug products labeled to contain 3 mg of drospirenone and 0.02 mg of ethinyl estradiol. c.17-hydroxy-6β,7β:15β,16β-dimethylene-3-oxo-17β-pregn-4-ene-21-carboxylic acid, γ-lactone. USP REFERENCE STANDARDS 11 USP Drospirenone RS USP Ethinyl Estradiol RS USP Ethinyl Estradiol Related Compound B RS 19-Nor-17α-pregna-1,3,5(10),9(11)-tetraen-20-yne- 3,17-diol. C 20H 22O

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