Packaging and storage Cefaclor for Oral Suspension shall be kept in tightly closed containers and stored at a temperature not exceeding 30º. After constitution, it should be used within the period stated on the label.
Identification Complies with the test for Identification B described under Cephadine, page65.Apply separately to the plate, 20 μl of each of the following solutions. For solution (A), constitute the oral suspension as directed in the labeling. Mix a portion of the resulting suspension with water to obtain a concentration of 2 mg of cefaclor per ml, filter and use the filtrate. Solution (B) contains 2 mg/ml of Cefaclor RS in water.
PH 2.5 to 5.0,in the suspension constituted as directed in the labeling (Appendix4.11).
Water Not more than 2.0 per cent W/W (Karl Fischer Method, Appendix4.12).
solution
Assay Constitute Cefaclor for Oral Suspension as directed in the labeling. Proceed as directed in the microbiological assay of Cefaclor according to the “Microbiological assay of Antibiotics”(Appendix 6.10), using an accurately measured volume of the oral suspension, freshly mixed and free from air bubbles, diluted with sufficient Buffer 1 to obtain a stock solution having a convenient concentration. Dilute this stock solution quantitatively and stepwise with Buffer1.
Other requirements Complies with the requirements described under “Oral Liquids” (Appendix1.16).