QUALITY CONTROL TESTS FOR CAPSULES - EXPERIMENT

EXPT NO: 07                                                                                                            DATE:

QUALITY CONTROL TESTS FOR CAPSULES

AIM: To carry out the various quality control tests for Capsules

PROCEDURE:

Capsules can be evaluated for the following tests:

1.       Weight variation test

2.       Content uniformity test

3.       Disintegration test

4.       Dissolution test.

WEIGHT VARIATION TEST:

Twenty capsules are weighted individually and the average weight is determined .If the weight of each capsule is within ± 10 % of the average weight, it passes the test. If this requirement is not met, than the weight of the contents of each individual capsule is determined with the average weight of contents.

CONTENT UNIFORMITY TEST:

This test is performed when specified by individual monographs. In this case, 30 capsules are selected, 10 of which are assayed by the specified procedure. The requirements are met if 9 of the 10 are within the specified potency range of 85 to 115 %, and the tenth is not outside 75 to 125 %. If more than 1, but less than 3, of the first 10 capsules fall out side the 85 to 115 % limits, the remaining 20 are assayed The requirements are met if all 30 capsules are with in 75 to 125 % of the specified potency range, and not less than 27 of the 30 are within the 85 to 115% range.

DISINTEGRATION TEST:

Disintegration test is usually not required for ordinary capsules. Disintegration test is required only for enteric-coated capsules. Five capsules are placed in a tube. The button of the tube is covered with 10-mesh screen. The tube is allowed to move up and down in a trough containing 0.6% VN HCL for three hours. The acid is maintained at 35°-39° C in this specified time the coating particles alone will pass through the mesh but all other portions of the capsule will retain on the mesh screen. The acid in the trough is replaced with a solution of standard pH 6-8. The tube is then allowed to move up and down into this solution for one hour. At the end of this period,, all particles will pass through the mesh except the fragments of coating materials and gelatin shells. If it fails to comply the test, the procedure should be repeated with another five capsule.

DISSOLUTION TEST:

Procedure is similar to those employed in the case of tablets.

STORAGE OF CAPSULES:

Capsules are packed either in strip packing or blister packing. Capsules should be stored in cool place with controlled humidity. At higher temperatures, due to loss of moisture, the capsules become brittle and tend to crack. In humid atmosphere the capsules absorb moisture and loose their shape.

REFFERENCE: The theory and practice of industrial pharmacy, by Libermann & Lachman, P 1996