Quality control tests for capsules are very important while manufacturing, these tests entail the company to see if they meet the standards. The goal of testing is to identify any issues that need attention during the manufacturing process. Good quality control helps companies meet consumer demands for better products.
Definition of Capsules
Capsules are solid dosage forms in which manufacturers enclose the drug substance in a water-soluble shell or envelope. They make the capsule shell from gelatin. Capsules are of two types: hard gelatin and soft gelatin.
Quality Control Test for Capsules
The hard and soft gelatin capsules should be subjected to following tests:
- Physical Tests
- Shape and size
- Disintegration test
- Weight variation
- Chemical Tests
- Dissolution test
- Content uniformity
- Moisture permeation test
- Stability testing
01. Shape and Size
A capsule diameter sorter allows it to pass to the next unit of any capsule within 0.02inch of theoretical diameter. The capsules are fed to it automatically from the diameter sorter by a pneumatic conveyor. In this unit, the analyst discards any capsule whose colour does not match the reference colour standard for that product, while the remaining capsules pass the test.
02. Disintegration Test
The Disintegration test determines whether capsules disintegrated with a prescribed time when placed in a liquid medium under the prescribed integral conditions.
Method:
According to B.P and which applies to hard and soft gelatin capsules.
- Introduce 1 capsule in each tube and suspend the apparatus in a beaker containing 60 ml water at 37 degree centigrade.
- Operate the apparatus for 30 min, remove the assembly from the liquid.
- The capsule passes the test if no residue remains on the screen of the apparatus or if the residue remains, it consists of fragments of shells, if a soft mass with no palpable core. If the analyst uses the disc, any residue remaining on its lower surface should consist only of shell fragments.
03. Weight Variation
Generally, analysts perform weight variation tests differently for hard and soft gelatin capsules, as listed below.
For Hard Capsules
Weigh about 20 capsules individually and calculate the avg. weight. The individual weights should be in the limits of 90-110%of avg. weight. Weigh 20 capsules individually. Remove the net content of each capsule with the aid of a small brush. Weigh the empty shells individually.
Net weight of contents individually = The weight of shell-gross weight.
Determine the average net content from the sum of individual weight. Then determine the difference between each individual net content and average net content.
For Soft Capsules
Proceed as directed under hard capsules, but determine the net weight of the contents of individuals as follows:
- Weigh the capsules individually then cut and open the capsules.
- Remove the contents by washing with the suitable solvent.
- Allow the solvents to evaporate from the shells at room temperature.
- Weigh the individual shells.
- Calculate the net contents.
04. Dissolution Test
The dissolution test uses a dissolution apparatus. The analyst places the capsule in a basket, immerses it in the dissolution medium, and rotates it at a specified speed. A covered 1000 ml glass vessel holds the dissolution medium, and a suitable constant-temperature water bath maintains it at 37 °C. The individual monograph specifies the stirrer speed and the type of dissolution medium.
05. Content Uniformity
10 capsules are taken and subjected to assay. 9 of 10 capsules should be in the range of 15%. And 10 capsules are beyond +15% range then 20 capsules are assayed. All capsules within range of +25%.
06. Moisture Permeation Test
The degree and rate of moisture permeation test is determined by packaging the dosage unit together with a colour revealing desiccant pellet. Expose the packaged unit to know relative humidity over a specified time. Observe the desiccant pellet for colour change.
07. Stability Testing
Stability testing of capsules determines the physicochemical stability of the drug substance in the finished drug product under specified packaging and recommended storage conditions. It also checks the intrinsic stability of the active drug molecules and the effect of environmental factors.
Conclusion
In this article we discussed the quality control tests for capsules which includes physical tests and chemical tests. We have written all the possible information and hope that this will help you. If you have any queries regarding this topic don’t hesitate to post it in the comment box. If you like this article please bookmark our page. Stay tuned for more updates.
Frequently Asked Questions
These are some commonly asked questions by most of the viewers regarding quality control tests for capsules.
01. What is Quality Control?
The word quality control refers to the collection of methods used to assure a pharmaceutical product’s identification and purity. A pharmaceutical product is tested chemically, physically, and sometimes microbiologically.
02. What are Disintegration times of Capsules?
- Gastro resistant capsule DT 2 hrs without disk in 0.1 M Hcl and phosphate buffer pH 6.8 for further 60min as per BP.
- Hard and soft gelatin capsules DT 30 min as per BP & USP.
03. Which tablets are used in calibration of dissolution apparatus?
Non disintegrating (Salicylic acid) and disintegrating (Prednisone) tablets are majorly used in the calibration of dissolution test apparatus.
04. How many conditions are there in stability?
There are three stability conditions:
- Long term or Controlled Room
- Temperature (CRT)
- Accelerated and Intermediate.