|
Quality Control Specifications
|
Lot specific results are available in the Certificate of Analysis, which is available at www.atcc.org or by contacting ATCC technical service.
SPECIFICATION CERTIFICATE
|
Test
|
Specification
|
|
pH1
|
7.1 to 7.4
|
|
Osmolality2
|
256 to 286 mOsm/kg
|
|
Endotoxin3
|
≤ 0.25 EU/mL
|
|
Mycoplasma4
|
Tested Negative
|
|
Sterility5
|
Pass
|
*Please consult the Certificate of Analysis for lot-specific test results.
- Measured with a standard pH meter. Meters are calibrated daily using standards traceable to the National Institute of Standards Technology using guidelines outlined in the current edition of USP.
- Measured with a standardized osmometer, i.e. freezing point depression. Meters are calibrated daily using standards traceable to the National Institute of Standards Technology using guidelines outlined in the current edition of USP.
- Chromogenic LAL Assay using guidelines outlined by the manufacturer & FDA (December 1987), “Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices”.
- Large volume method of Kern and Barile as per “Isolation of Mycoplasmas from Cell Culture by Agar and Broth Techniques,” M.F. Barile and G.J. McGarrity in Methods in Mycoplasmology, Vol. 11.5 Razin and J.G. Tulley, eds., Academic Press, NY (1983) pp. 159-165.
- Tested by membrane filtration techniques.
|