Implant checking experiments
Implant checking experiments
Implants (Appendix I J of the 2010 edition of the Chinese Pharmacopoeia, Part II) are sterile solid preparations of drugs and excipients for implantation in the body. Implants are usually implanted by special syringes, or can be implanted by surgical incision, and the drug is released continuously in the body and maintained for a longer period of time. For the quality requirements of implantable agents, in addition to the test items specified in the Pharmacopoeia under species, the "loading discrepancy" and "sterility" should also be checked.
Operation method
"Volume discrepancy" checking method
Principle
This method applies to the checking of loading discrepancies of implantants in single-dose bottles or ampoules. The purpose of this check is to control the consistency of loading between bottles (or ampoules) to ensure the accuracy of the dose used.
Materials and Instruments
Implant Move I. Instruments and Appliances Caveat 1. When opening the ampoule for implantation, avoid glass chips falling into or spilling out; when opening the rubber stoppered glass vial for implantation, slightly open the rubber stopper to equalize the air pressure inside and outside of the vial, and then tighten the cap before weighing. 2. When washing the container with water or ethanol after pouring off the content, do not wipe off the writing of the number on the outside of the bottle, so as not to affect the weighing result; and pair the empty container with the original rubber stopper or the neck of the ampoule and put it back to the original fixed position. 3. The empty containers can be heated at about 70°C for 1-2 h, or dried in a desiccator for a longer period of time. 4. When weighing empty containers, attention should be paid to the pairing of the bottle with the stopper (or the neck of the broken ampoule). For more product details, please visit Aladdin Scientific website.
Water Ethanol
Analytical balances Empty containers Dryers
Analytical balance: 0. 1 mg capacity (for implantants with an average charge of 0. 15 g and below) or 1 mg capacity (for implantants with an average charge of 0.15 g and above).
II. Methods of operation
1. Take 5 bottles (sticks) of test material, remove the aluminum cap and bottle label (if paper label, wet with water and remove; if the label is printed directly on the glass, can be wiped with organic solvents), the outer wall of the container is washed with ethanol, placed in a desiccator and placed in 1-2 h, to be dry, numbered and placed in a fixed position in turn.
2. Tap the rubber stopper or the neck of the ampoule, so that all the powder or small particles of implantable drugs attached to it fall down, open the container (pay attention to avoiding foreign objects such as glass shavings falling into the container), respectively, quickly and accurately weighed each vial (bottle), pouring out the contents of the container washed with water or ethanol, and then return it to the original fixed position in order, and then after drying it in suitable conditions, then accurately weighed each container to find out the amount and average amount of each vial (bottle). A bottle (branch) of the amount of filling and the average amount of filling.
3. Re-examination
In the initial test, if the volume of one bottle (vial) exceeds the limits of the volume difference, another 10 bottles (vials) shall be retested according to the methods under 1 and 2.III. Records and calculations
1. Record each weighing data.
2. Calculate the weight of the contents of each bottle (vial) based on the difference between the weight of the bottle (vial) and the empty bottle.
3. Divide the sum of the weight of the contents of each bottle (vial) by 5 (or 10 in the case of retesting) to obtain the average loading ( m-pints ), retaining three significant digits.
4. Determine the permissible loading range (m flat ± m flat X loading variance limit) by applying the loading variance limits as shown in the table below.
5. Where the permissible filling range is exceeded and is marginal, the percentage difference in the filling of the bottle (vial) should be calculated by comparing it to the average filling, and the limits of the difference in the filling specified in the table above should be used as the basis for the decision (to avoid the influence of numerical modification in the calculation of the permissible filling range).
IV. Results and determinations
1. Each bottle (bottle) is judged to be in compliance if none of its contents exceeds the permissible loading range (m psi m psi X the limit of loading variance) or if none of its loading variance exceeds that specified in the table above.2. If more than one bottle (vial) of implantable agent exceeds the limit of variance in filling when the quantity in each bottle (vial) is compared with the average quantity, it is judged to be non-compliant.
3. preliminary examination results only 1 bottle (branch) of the loading difference beyond the limits of the loading difference, another 10 bottles (branch) retest, retest results of each bottle (branch) of the loading difference are not beyond the limits of the loading difference, judged to be in accordance with the provisions; if there is still a bottle (branch) or 1 bottle (branch) or more than 1 bottle (branch) beyond the limits of the loading difference, judged to be not in accordance with the provisions.