The quality requirements of the syrup: it should be clarified.
During storage, there should be no mold, rancidity, gas generation or other deterioration, and a small amount of precipitate that can easily disperse when shaken
.
In addition to the inspection items specified under each variety (generally, the relative density and pH value should be checked), the loading volume and the microbial limit should also be checked
.
(1) Checking the quantity
1.
Brief description
(1) This law is applicable to single-dose filling and multi-dose filling syrup inspection, with the purpose of ensuring the accuracy of the dosage
.
(2) Multi-dose filled syrups shall be inspected according to the minimum filling quantity inspection method
.
2.
Method of operation
(1) Single-dose filling syrup: Take 5 test samples, open them carefully, pour the contents into standardized dry measuring cylinders, pour out as much as possible, check at room temperature, and read out The quantity of each piece (accurate to 1% of the quantity)
.
(2) Multi-dose filled syrups (applicable to those whose marked filling quantity is calculated by volume): operate in accordance with the minimum filling quantity inspection method (general rule 0942)
.
Take 5 test samples (take 3 samples if the marked capacity is more than 50ml).
When opening, take care to avoid loss, and transfer the contents to a pre-standardized dry measuring cylinder (the size of the measuring tool should be at least the volume to be measured (Accounting for 40% of its rated volume), after the viscous liquid is poured out, unless otherwise specified, invert the container for 15 minutes, as much as possible
.
Use a pre-standardized dry volume human syringe to drain the volume of 2ml or less
.
Read the volume of the contents of each container and find the average volume
.
3.
Matters needing attention
(1) The graduated cylinder used should be clean, dry, and calibrated regularly; its maximum capacity should be consistent with the labelled volume of the test product, or no more than twice the labelled volume
.
(2) After the contents of the test product are poured into the graduated cylinder, the container should be turned upside down for 15 minutes to make it as full as possible, and then read the content of each container
.
4.
Results and Judgment
(1) Single-dose filling syrup: Comparing each bottle with the labelled volume, if there is no more than one bottle less than the labelled volume, and not less than 95% of the labelled volume, it is judged to meet the requirements; Otherwise, it is not in compliance with the regulations
.
(2) Multi-dose filling syrup
1) The filling quantity and average filling quantity of the contents of each container, according to the minimum filling quantity inspection method (volume method), the filling quantity of each container is not less than the minimum allowable filling quantity; and the average filling quantity is not less than The marked loading quantity is judged to be in compliance with the regulations
.
2) If one container does not meet the requirements, take another 5 (3 for more than 50ml) for retest
.
All the results of the retest meet the requirements, but they can still be judged as in compliance
.
3) The average filling quantity and the filling quantity of each container (calculate the percentage based on the marked filling quantity), and take three significant figures to judge the result
.
5.
Records and calculations
(1) recording temperature, means for marking the number and amount of test sample, the measured amount of loading of each container contents
.
(2) Divide the total volume of each container by 5 (or 3) to get the average volume
.
(3) Calculate the volume and average volume of the contents of each container
.
Calculate the minimum amount allowed
.
(2) Microbial limit inspection
Unless otherwise specified, the microbial limit inspection of non-sterile products for syrups: microbial enumeration method (General Rule 1105) and control bacteria inspection (General Rule 1106) and non-sterile drug microbial limit standards (General Rule 1107) inspection should meet the requirements
.
Related link: Inspection method of powder
