What is the evaluation test for capsule?
What is the evaluation test for capsule?
In-process quality control tests for capsule drug products Gel ribbon thickness and uniformity across the ribbon. Softgels seal thickness at the time of encapsulation. Weight of the capsule fill and its variation from capsule-to-capsule. Weight of the capsule shell and its variation from capsule-to-capsule.
What are the official USP tests required for capsules?
All USP tablets must pass a test for disintegration, which is conducted in vitro using a disintegration test apparatus. The apparatus consists of a basket-rack assembly containing six open-ended transparent tubes of USP-specified dimensions, held vertically upon a 10-mesh stainless steel wire screen.
How will you determine the hardness of capsule shell?
Gelatin Capsule Hardness tester is a device that indicates the hardness of a capsule by measuring the effect on its surface of a localized penetration by a standardized flat-shaped indenter made of hard steel.
Why opacifying agent are used in capsule shell?
Opacifying agents. Opacifiers (e.g., titanium dioxide) may be included to make clear gelatin opaque. Opaque capsules may be employed to provide protection against light or to conceal the contents.
Which type of apparatus is used in the dissolution testing of capsule?
Basket types apparatus
Basket types apparatus are used for ( for Tablet and Capsule) it consists of the following parts: A. Cylindrical vessel: Basket types dissolution apparatus Made of borosilicate glass or suitable transparent materials with a hemispherical bottom and its nominal capacity of 1000 ml.
How do you perform a disintegration test?
Lift the basket from the fluid, and observe the tablets: all of the tablets disintegrate completely. If one or two tablets fail to disintegrate completely, repeat the test on 12 additional tablets: not less than 16 of the total of 18 tablets tested disintegrate completely.
What is friability test?
Friability testing determines how much mechanical stress tablets are able to withstand during their handling by the customer.
What is inprocess quality?
IPQC stands for in process quality control. These are checks that are carried out before the manufacturing process is completed. The function of of in-process controls is monitoring and if necessary adaption of the manufacturing process in order to comply with the specifications .
Which test is performed to determine the integrity of gelatin capsule for determining the shelf life of capsules?
1.STABILITY TESTS Stability tests for capsules are performed to know the integrity of gelatin capsule shell ( but not to know the stability of therapeuticallay active agent ) and for determining the shelf life of capsules.
What is weight variation test?
In the case of pharmaceutical dosage forms, the weight variation test (also referred to as uniformity of dosage units) is a non-destructive test that compares the individual weights of a sample of tablets with the average weight of the selected sample.
Which method is used to prepare capsules?
Hard gelatin capsules are manufactured by the dipping method which is dipping, rotation, drying, stripping, trimming, and joining. Softgels are filled at the same time as they are produced and sealed on the rotary die of a fully automatic machine.
Which of the following plasticizer is preferred in capsule manufacturing?
The most common plasticizer used for soft gelatin capsules is glycerol. Sorbitol, maltitol, and polypropylene glycol can also be used in combination with glycerol.