Membrane agent inspection test
Membrane (Appendix I M of the 2010 edition of the Chinese Pharmacopoeia, Part II) refers to the membrane preparation made by processing the drug and suitable film-forming materials. It is used for oral administration or mucous membrane. For the quality requirements of film preparation, in addition to the appearance of integrity and smoothness, consistent thickness, uniform color, no obvious air bubbles, as well as the test items stipulated in the Pharmacopoeia under the item of varieties, it should also be checked for "weight difference" and "microbial limit".
Operation method
"Weight discrepancy" checking method
Principle
This method is suitable for checking the weight difference of membrane agent. The production of film dosage mostly adopts casting method, and the flow rate of liquid, coating speed, as well as the process of stripping and cutting all affect the weight difference of film dosage. The purpose of this check is to control the consistency of the weight of each tablet to ensure the accuracy of the dosage. Where the content uniformity check of the membrane agent, no longer carry out the weight difference check.
Materials and Instruments
membrane agent Move I. Instruments and Appliances Caveat The number of film pieces should be carefully checked before and after weighing. During the weighing process, direct hand contact with the test material should be avoided. Removed tablets should not be returned to the original packaging container.. For more product details, please visit Aladdin Scientific website.
Water
Analytical balance Flat weighing flask Surgical forceps
Analytical balance (0.1 mg or 0.01 mg sensitivity), flat weighing flask, curved or flat-tipped tweezers.
II. Methods of operation
1. Take the empty weighing bottle, weigh precisely; then take 20 slices of the test article, put it into the weighing bottle, weigh precisely. The difference between the two weighing values is the total weight of the 20 test pieces, divided by 20 to get the average weight (m flat ).
2. From the 20 pieces of test pieces which have been weighed to determine the total weight, take out 1 piece of test piece in turn with forceps and weigh them precisely to obtain the weight of each piece.III. Records and calculations
1. Record each weighing data.
2. Determine the average weight (m flat ), retaining three significant figures.3. Determine the allowable weight range (m psi m psi X weight variation limit) by using the weight variation limits specified in the table below.
4. In the case of a piece that exceeds the permissible weight range and is borderline. Compare the weight of the piece with the average weight, calculate the percentage of weight difference, and base your decision on the weight difference limits specified in the table above (to avoid numerical modifications in the calculation of the allowable weight range).
IV. Results and determinations
1. The weight of each piece does not exceed the permissible weight range (m pings m pings X weight difference limit); or the weight difference limit is exceeded by not more than 2 pieces of membrane, and none of them exceeds the limit by a factor of 1; are judged to be in compliance with the regulations.2. The weight of each piece, when compared to the average weight, is judged to be in noncompliance if more than two pieces of film exceed the limit of weight variation, or if not more than two pieces of film exceed the limit of weight variation, but one piece exceeds the limit by a factor of one.