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Lotion
Regarding the quality requirements of the lotion: it should be clarified that there should be no deterioration such as foreign matter, rancidity, etc.
(1) Checking the quantity
1.
2.
3.
4.
(1) The filling and average filling of the contents of each container shall be in accordance with the minimum filling inspection method (gravity method or volumetric method), and the filling volume of each container shall not be less than the allowable minimum filling volume; and the average filling shall be If the quantity is not less than the marked quantity, it will be judged to meet the requirements
(2) If one container does not meet the requirements, take another 5 (3 for 50ml or more) for retest
(3) The average filling quantity and the filling quantity of each container (calculate the percentage according to the marked filling quantity), and take three significant figures to judge the result
5.
(2) Microbial limit inspection
Unless otherwise specified, the microbial limit inspection of non-sterile products of the lotion: the microbial enumeration method (General Rule 1105) and the control bacteria inspection (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) shall meet the requirements
Tea
Quality requirements for tea preparations: Both tea and drinking tea bags should meet the relevant requirements of the drinking tea standards.
(1) Moisture check
1.
2.
(1) Sugar-free lumpy tea: Take the test product and break it, and operate according to the method under each corresponding item of the Chinese herbal medicine moisture determination method (General Rule 0832)
(2) Sugar-containing block tea: take the test product, break it into granules with a diameter of about 3mm, and operate according to the methods under the corresponding items of the moisture determination method of Chinese medicinal materials (General Rule 0832)
(3) Tea bag and decoction tea: take the test product and operate according to the methods under the corresponding items of the Chinese herbal medicine moisture determination method (General Rule 0832)
3.
The precautions are the same as the corresponding methods of the Chinese herbal medicine moisture determination method
.
4.
Results and Judgment
(1) Sugar-free lumpy tea: The water content of the test product does not exceed 12.
0%, and it is judged to meet the requirements
.
(2) Sugar-containing block tea: The water content of the test product does not exceed 3.
0%, and it is judged to meet the requirements
.
(3) Tea bag and decoction tea: the water content of the test product does not exceed 12.
0%, and it is judged to meet the requirements
.
5.
Records and calculations are the same as the corresponding methods of the Chinese herbal medicine moisture determination method
.
(2) Meltability inspection
1.
Brief description This law is applicable to the dissolution test of sugar-containing block tea
.
The purpose of this inspection is to control the quality of medicines
.
2.
Operation method Take 1 piece of test product, add 20 times the amount of hot water, stir for 5 minutes, and observe the result immediately
.
3.
Matters needing attention The hot water temperature should be 70~80℃
.
4.
Results and Judgment
(1) The sugar-containing block tea should be completely melted or slightly turbid, without scorching, etc.
, and it is judged to meet the requirements
.
(2) If the sugar-containing block tea can be completely melted or slightly turbid, but has scorched chips, it will be judged as non-compliant
.
5.
Record the sampling volume, solvent volume, time and observe the phenomenon of tea melting
.
(3) Weight difference check
1.
Brief description This law is applicable to the weight difference inspection of block tea.
The purpose of this inspection is to control the consistency of the weight of each piece
.
To ensure the accuracy of the dosage
.
2.
Method of operation
(1) Sugar-containing block tea: Take 10 pieces of the test product, weigh them separately, and compare the weight of each piece with the labeled weight
.
(2) Sugar-free block tea: Take 10 pieces of the test product, weigh them separately, and compare the weight of each piece with the labeled weight
.
3.
Precautions Avoid direct contact with the test product with your hands during the weighing process
.
4.
Results and Judgment
(1) Sugar-free block tea: According to the provisions of Table 15-22, the weight of each block is within the weight difference limit compared with the labeled weight; or the weight difference limit is not more than 2 pieces, and none of them exceed the weight difference limit.
If it exceeds the weight difference limit by 1 times, it will be judged as conforming to the regulations
.
Table 15-22 Limits for weight difference of non-sugar block tea
Comparing the weight of each piece with the marked weight, if it exceeds the weight difference limit by more than 2 pieces; or if it exceeds the weight difference limit, although there are no more than 2 pieces, but 1 piece exceeds the weight difference limit by 1 time, it is judged as non-conforming Regulations
.
(2) Sugar-containing block tea: According to the provisions of Table 15-23, the weight of each piece is within the weight difference limit when compared with the labeled weight; or the weight difference limit is not more than 2 pieces, and none of them exceeds the weight difference limit.
The weight difference limit is 1 times; all are judged to meet the regulations
.
Comparing the weight of each piece with the marked weight, there are more than 2 pieces that exceed the weight difference limit; or if the weight difference limit is not more than 2 pieces, but one piece exceeds the weight difference limit by 1 time, it is judged as non-compliance.
.
Table 15-23 Limits for weight difference of sugar-containing block tea
5.
Records and calculations
(1) Record the model of the analytical balance
.
(2) Record the data of each weighing
.
(3) According to the marked weight of each block, find the allowable block weight range
.
(4) Checking the difference in loading
1.
Brief description This law is applicable to the inspection of the difference in the filling quantity of tea bags and decoction tea
.
The purpose of this inspection is to control the consistency of the filling volume between the bags (boxes) and to ensure the accuracy of the dosage
.
2.
Method of operation
(1) Tea in bags and decoction tea: Take 10 bags (boxes) of the test product, weigh each bag (box) separately, open the seal, pour out the contents, and then weigh each empty packaging bag separately The weight of the (box) can be calculated for each bag (box)
.
(2) Compare the volume of each bag (box) with the labeled volume
.
3.
Matters needing attention
(1) When weighing, the contents of each bag (box) must be poured out completely
.
(2) Do not directly touch the test product with your fingers during the weighing process
.
4.
Results and Judgment
(1) Comparing the quantity per bag (box) with the marked quantity, according to Table 15-24, the quantity per bag (box) compared with the marked quantity does not exceed the difference limit of the quantity; or The limit of difference in quantity is not more than 2 bags (boxes), and none of them exceeds the limit of difference in quantity by 1 time
.
All were judged to meet the regulations
.
Table 15-24 The limit of the difference between the bagged tea and the decoction tea
(2) If more than 2 bags (boxes) are exceeded for the difference in quantity, or if the difference is not more than 2 bags (boxes), but there is 1 bag (box) that exceeds the difference in quantity by 1 time, both It was judged not to meet the regulations
.
5.
Records and calculations
(1) Record the model of the analytical balance
.
(2) Record each weighing data
.
(3) Calculate the weight of the contents of each bag (box)
.
(4) Calculate the allowable filling quantity range based on the marked filling quantity
.
(5) Microbial limit inspection
Unless otherwise specified, the microbial limit inspection of non-sterile products for tea: the microbial enumeration method (General Rule 1105), the control bacteria inspection (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) shall meet the requirements
.