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DOXYCYCLINE HYCLATE CAPSULES

Category Antibacterial; antiprotozoal.

      Doxycycline Hyclate Capsules contain the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C22H24N2O8. Strength available 100 mg (base).

      Dose Adults and children over 8 years of age weighing over 45 kg: 100 mg twice a day for one day, then 100 mg daily.

      Children over 8 years of age weighing 45 kg and under: 2.2 mg per kg of body weight twice a day for one day, then 2.2 mg per kg of body weight daily.

Contra-indication; Warning; Additional information See under Doxycycline Hyclate, p. 96.

Precaution See under Tetracycline Hydrochloride, p. 139.

Packaging and storage Doxycycline Hyclate Capsules shall be kept in tightly closed containers, protected from light.

Labelling The label on the container states the quantity equivalent to the amount of doxycycline.

Identification The capsule contents comply with the tests for Identification B, C and D described under Doxycycline Hyclate, p. 96. 

Water Not more than 8.5 per cent w/w (Karl Fischer Method, Appendix 4.12). 

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).

      Dissolution medium: water; 900 ml. 

      Apparatus 2: 75 rpm. Maintain a distance of 45±5 mm between the blade and the inside bottom of the vessel.

      Time: 30 minutes.

      Procedure Determine the amount of C22H24N2O8 dissolved from absorbances at the maximum at about 276 nm of filtered portions of the test solution, suitably diluted with Dissolution medium, if necessary, in comparison with a standard solution having a known concentration of Doxycycline Hyclate RS in the same medium (Appendix 2.2).

      Tolerances Not less than 80 per cent (Q) of the labelled amount of C22H24N2O8 is dissolved in 30 minutes.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

      Mobile phase, Diluent, Resolution solution, Standard preparation, Chromatographic system, and Procedure Proceed as directed in the Assay described under Doxycycline Hyclate, p. 96. 

      Assay preparation Remove, as completely as possible, the contents of not less than 20 Doxycycline Hyclate Capsules, and weigh accurately. Mix the combined contents, and transfer an accurately weighed portion, containing about 100 mg of doxycycline, to a 100-ml volumetric flask, add 75 ml of Diluent, sonicate for 5 minutes, shake for 15 minutes, dilute with Diluent to volume, mix, and filter.

      Calculation Calculate the content of C22H24N2O8 in the portion of the Capsules taken, using the declared content of C22H24N2O8 in Doxycycline Hyclate RS.

Other requirements Comply with the requirements described under “Capsules” (Appendix 1.16).

 

MONOGRAPHS • DOXYCYCLINE HYCLATE CAPSULES
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หมายเหตุ / Note : TP II 2011 PAGE 98-99