Mammalian cell culture medium (2)

5 traits

Pink or almost white solid powder

6 requirements

The mammalian cell culture medium should meet the technical requirements shown in Table 2

Table 2 Technical requirements

7 Test method

Unless otherwise specified, only reagents confirmed to be analytically pure and purified water specified in the 2005 edition of the Pharmacopoeia of the People's Republic of China are used in the analysis

7.

Weigh the labeled amount of laboratory sample per liter, place it in a 1000 mL beaker, add 1000 mL of water, and stir until it dissolves

7.

Weigh the labeled amount of laboratory sample per liter, place it in a 1000 mL beaker, add 1000 mL of water, and stir until it dissolves

7.

According to the 2005 edition of the People's Republic of China Pharmacopoeia Erbufu recorded VIIL loss on drying method

Take the arithmetic mean of the two parallel determination results as the determination result, and the absolute difference between the two parallel determination results shall not be greater than 10% of the arithmetic mean of the two determination values

7.

Weigh the labeled amount of laboratory sample per liter, place it in a 1000 mL beaker, add 1000 mL of water, and stir until it dissolves

Take the arithmetic mean of the two parallel determination results as the determination result, and the absolute difference between the two parallel determination results shall not be greater than 5% of the arithmetic mean of the two determination values

7.

According to the gel method in the 2005 edition of the People's Republic of China Pharmacopoeia Appendix E Bacterial Endotoxin Inspection Method

Weigh 1/100 of the labeled laboratory sample per liter, accurate to 0.
0001g, add 10mL of bacterial endotoxin test water (commercially available) to dissolve it, absorb 0.
1mL of the solution and add 3.
9mL of bacterial endotoxin test water (commercially available) to mix Evenly get the test solution
.

7.
6 Determination of microbial limit

According to the 2005 edition of the People's Republic of China Pharmacopoeia Appendix XIJ Microbial Limit Inspection Method, the inspection items are the number of bacteria and mold
.
The inspection method adopts the petri dish method
.

Weigh 1g of laboratory sample, accurate to 0.
01g, add 10mL of sterile purified water to dissolve, and mix well to obtain the test solution
.

7.
7 Cell growth test

7.
7.
1 Method summary

7.
7.
1.
1 The containers and solutions used in this test are all sterile, and the test operations are all aseptic operations
.

7.
7.
1.
2 Cells are grown in a cell culture medium containing 10% calf serum for 48h-72h at a constant temperature of 37°C, and the cell morphology is observed and the cell count is performed; after the cells have grown for 48h-72h, replace the cells that do not contain small cells.
Cell culture medium of bovine serum, continue to culture for 48 hours, observe the cell morphology and count the cells
.

7.
7.
2 Reagents and materials

7.
7.
2.
1 Calf serum : Three appendix XⅢD of Pharmacopoeia 2005 edition of the People's Republic of China
.

7.
7.
2.
2 Balanced salt solution: weigh 0.
2g potassium chloride , accurate to 0.
01g; anhydrous potassium dihydrogen phosphate 0.
2g, accurate to 0.
01g; sodium chloride 8.
0g, accurate to 0.
01g; anhydrous dihydrogen phosphate Sodium 1.
15g, accurate to 0.
001g; add 1000mL purified water, mix well, filter and sterilize
.

7.
7.
2.
3 VERO cells: the generation number does not exceed 150 generations
.

7.
7.
2.
4 Cell culture solution: Prepare according to the requirements of the product instructions
.

7.
7.
2.
5 Trypsin solution: Weigh 2.
5g trypsin (activity 1:250), accurate to 0.
01g, add 1000mL balanced salt solution, mix well, filter and sterilize
.

Related links: mammalian cell culture medium (1)