Capsule inspection test
Capsule inspection test
Capsule (Chinese Pharmacopoeia, 2010 Edition, Part II, Appendix E) refers to solid preparations in which the drug or excipients are filled in hollow capsules or sealed in soft capsules. Capsules are divided into hard capsules (commonly known as capsules), soft capsules (pills), extended-release capsules, controlled-release capsules and enteric capsules, mainly for oral use. Quality requirements for capsules, in addition to the appearance should be neat, no adhesion, deformation, leakage or rupture of the capsule shell phenomenon, and should be free of odor, as well as the Pharmacopoeia varieties of the test items specified under the item, should also check the "loading differences" and "disintegration time" (or "solubility"). "Dissolution degree", "release degree").
Operation method
"Volume discrepancy" checking method
Principle
This method is applicable to the checking of loading discrepancy of capsule dosage forms. Where it is stipulated to check the content uniformity of the capsule may not be checked for loading discrepancy. In the production process, due to the empty capsule volume, the fluidity of the powder, as well as technology, equipment and other reasons, can cause differences in the contents of the capsule dose filling. The purpose of this check is to control the consistency of the loading of each capsule to ensure the accuracy of the dose.
Materials and Instruments
Encapsulants Move I. Instruments and Appliances Caveat 1.In the two weighings of each capsule, attention should be paid to the order of numbering and the matching of the capsule body and capsule cap without confusion. 2.Wash the soft capsule shell should be immiscible with water and volatile organic solvents, of which ether is the best. Volatile solvent, should be in a ventilated place to make natural dissipation, not heating or long time in a dry place, so as to avoid water loss of the capsule shell. 3.Before and after weighing, the number of capsules should be carefully checked. During the weighing process, avoid direct hand contact with the test material. The removed capsules should not be put back into the original packaging container of the test material. For more product details, please visit Aladdin Scientific website.
Analytical balances Weighing flasks Surgical forceps Scissors Blades
1. Analytical balance with a 0.1 mg capacity (for capsules with an average fill size of 0.30 g or less) or 1 mg capacity (for capsules with an average fill size of 0.30 g or more).
2. Flat weighing flasks.
3. Small brushes.
4. scissors or blades.
5. Curved or flat-tipped surgical forceps.
II. Methods of operation
1. hard capsule unless otherwise specified, take 20 test articles, respectively, precision weighing of each capsule, remove the capsule cap, pour out the contents (shall not lose the capsule shell), with a small brush or other suitable equipment will be inside and outside the capsule shell (including the capsule and capsule cap), and in turn, precision weighing of each capsule shell, you can find out the contents of the contents of each capsule and the average amount of loading.
2. Unless otherwise specified, take 20 soft capsules of the test article, weigh each capsule precisely, place them in a fixed position, cut the capsule shell with scissors or razor blade to pour out the contents (no loss of the capsule shell), wash with volatile solvents such as ether and put it in a ventilated place to let the solvent evaporate naturally, then weigh each capsule shell in turn to find out the contents of the contents of the loading volume and the average loading volume.
III. Records and calculations
1. Record the weighing data for each capsule and its own shell in turn.
2. Calculate the weight of the contents of each capsule from the difference between the weight of each capsule and the weight of the capsule shell, retaining three significant figures.
3. Divide the sum of the weight of the contents of each capsule by 20 to obtain the average loading per capsule (m flat), retaining three significant figures.
4. Find the allowable loading range (m flat m flat loading variation limit) by following the loading variation limits specified in the table below.Average Load Load Variance Limit 0.30 g or less 士10%0.30 g to more than 0.30 g 士7. 5%.
5. Where the permissible loading range is exceeded and is marginal, the percentage difference in loading for the grain shall be calculated by comparing it with the average loading, and the basis for the determination shall be the limit of the difference in loading specified in the table above (to avoid the influence of numerical modification in the calculation of the permissible loading range).
IV. Results and determinations
1. Each capsule is not out of the allowable loading range (m flat X m flat X loading variance limit); or compared to the average loading, none of the capsules exceeds the loading variance limit in the table above or no more than 2 capsules exceed the loading variance limit and none of them exceeds the limit by a factor of 1 is considered to be in compliance.2. If the quantity of each capsule, when compared with the average quantity, exceeds the limit of variation in quantity by more than 2 capsules, or if the limit of variation in quantity is not exceeded by more than 2 capsules, but 1 capsule exceeds the limit by a factor of 1, it is judged to be a nonconformity.