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Usp.org

Revision BulletinOfficial October 1, 2010 Tetracycline 1
Acceptance criteria: 90.0%–125.0%
Tetracycline Hydrochloride Capsules
PERFORMANCE TESTS
DEFINITION
Tetracycline Hydrochloride Capsules contain NLT 90.0% and Change to read:
NMT 125.0% of the labeled amount of C22H24N2O8 · HCl.
DISSOLUTION 711
IDENTIFICATION
•Test 1• (RB 1-Oct-2010)
• The retention time of the major peak of the Sample solution Medium: Water; 900 mL
corresponds to that of the Standard solution, as obtained in Apparatus 2: 75 rpm; maintain a distance of 45 ± 5 mm
between the blade and the inside bottom of the vessel.
Time: 60 min; 90 min for 500-mg Capsules
Detector: UV 276 nm
PROCEDURE
Standard solution: USP Tetracycline Hydrochloride RS in
Diluent: Dimethylformamide and 0.1 M ammonium oxalate
Sample solution: Pass a portion of the solution under test
Mobile phase: Dimethylformamide, 0.1 M ammonium oxa-
late, and 0.2 M dibasic ammonium phosphate (27:68:5).
Analysis: Determine the amount of C22H24N2O8 · HCl dis-
Adjust, if necessary, with 3 N ammonium hydroxide or 3 N solved by using UV absorption on portions of the Sample phosphoric acid to a pH of 7.6–7.7.
solution suitably diluted with Medium, if necessary, in com- Standard solution: 0.5 mg/mL of USP Tetracycline Hydro-
parison with a Standard solution having a known concentra- tion of USP Tetracycline Hydrochloride RS.
Sample solution: Equivalent to 0.5 mg/mL of tetracycline
Tolerances: NLT 80% (Q) of C22H24N2O8 · HCl is dissolved.
hydrochloride in Diluent from NLT 20 Capsules. [NOTE—Soni- •Test 2: If the product complies with this test, the labeling
indicates that the product meets USP Dissolution Test 2.
System suitability solution: 100 µg/mL of tetracycline hy-
Medium: Water; 900 mL, deaerated.
drochloride and 25 µg/mL of USP 4-Epianhydrotetracycline Apparatus 2: 75 rpm; maintain a distance of 45 ± 5 mm
between the blade and the inside bottom of the vessel.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.) For Capsules labeled to contain 250 mg: 30 and 60 min For Capsules labeled to contain 500 mg: 30, 60, and 90 Detector: UV 280 nm
Guard column: 4.6-mm × 3-cm; 10-µm packing L7
Detector: UV 276 nm
Column: 4.6-mm × 25-cm; 5- to 10-µm packing L7
Standard solution: USP Tetracycline Hydrochloride RS in
Flow rate: 2 mL/min
System suitability
Sample solution: At the times specified, withdraw a known
Samples: Standard solution and System suitability solution
volume of the solution under test, and pass it through a [NOTE—The relative retention times of 4-epianhydrotetra- suitable filter. Dilute with Medium, if necessary. Replace the cycline and tetracycline are 0.9 and 1.0, respectively.] volume withdrawn with the same amount of Medium, pre- Suitability requirements
Resolution: NLT 1.2 between the 4-epianhydrotetra-
Blank: Medium
cycline and tetracycline peaks, System suitability solution Tolerances: See Tables 1 and 2.
Relative standard deviation: NMT 2.0%, Standard
Analysis
Samples: Standard solution and Sample solution
For Capsules Labeled to Contain 250 mg
Calculate the percentage of tetracycline hydrochloride Time (min)
Amount Dissolved
(C22H24N2O8 · HCl) in the portion of Capsules taken: Result = (rU/rS) × (CS/CU) × P × F × 100 = peak response of tetracycline from the Sample = peak response of tetracycline from the Standard For Capsules Labeled to Contain 500 mg
Time (min)
Amount Dissolved
= concentration of USP Tetracycline Hydrochloride RS in the Standard solution (mg/mL) = nominal concentration of the Sample solution = potency of USP Tetracycline Hydrochloride RS • UNIFORMITY OF DOSAGE UNITS 905: Meet the requirements
IMPURITIES
Organic Impurities
PROCEDURE: LIMIT OF 4-EPIANHYDROTETRACYCLINE
Diluent, Mobile phase, Sample solution, Chromato-
graphic system, and System suitability: Proceed as di-
2010 The United States Pharmacopeial Convention All Rights Reserved. 2 Tetracycline
Standard solution: 10 µg/mL of USP 4-Epianhydrotetra-
ADDITIONAL REQUIREMENTS
cycline Hydrochloride RS in DiluentPACKAGING AND STORAGE: Preserve in tight, light-resistant
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of 4-epianhydrotetracycline hy- Add the following:
drochloride in the portion of Capsules taken: • LABELING: When more than one Dissolution test is
U/rS) × (CS/CU) × F × 100 given, the labeling states the test used only if Test 1 is not = peak response of 4-epianhydrotetracycline from • USP REFERENCE STANDARDS 11
= peak response of 4-epianhydrotetracycline from USP 4-Epianhydrotetracycline Hydrochloride RS 2-Naphthacenecarboxamide, 4-(dimethylamino)- = concentration of USP 4-Epianhydrotetracycline 1,4,4a,5,12,12a-hexahydro-3,10,11,12a-tetrahydroxy-6- Hydrochloride RS in the Standard solution methyl-1,12-dioxo, monohydrochloride, [4R-(4α, 4aβ, = nominal concentration of tetracycline hydro- chloride in the Sample solution (mg/mL) (4S,4aS,5aS,6S,12aS)-4-(Dimethylamino)- Acceptance criteria: NMT 3.0%
1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a- pentahydroxy- 6-methyl-1,11-dioxo-2-naphthacenecarbox- SPECIFIC TESTS
LOSS ON DRYING 731: Dry 100 mg of Capsule contents in a
capillary-stoppered bottle in vacuum at a pressure not ex- ceeding 5 mm of mercury at 60° for 3 h: it loses NMT 4.0% 2010 The United States Pharmacopeial Convention All Rights Reserved.

Source: http://www.usp.org/sites/default/files/usp_pdf/EN/tETRACYCLINEHYDROCHLORIDECAPSULES-M81820.pdf

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