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Quality Control Specifications
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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
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Test
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Specification
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Sterility Testing1
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Pass
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Osmolality
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400 to 500 mOsm
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pH
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5.0 -6.0
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Mycoplasma2
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Negative
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Endotoxin3
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For information
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Cell Growth Testing4
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Pass
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- Tested by membrane filtration techniques in accordance with United States Pharmacopeia Chapters [71] and [1211].
- Large-volume method of Kern and Barile as per “Isolation of mycoplasmas from cell culture by agar and broth techniques,” Barile MF and McGarrity GJ. In: Tully JG and Razin S, eds. Methods in Mycoplasmology, Vol. II. New York: Academic Press; 1983; pp. 159-165.
- Chromogenic LAL assay using guidelines outlined by the manufacturer and 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.”
- Growth-promotion capability is analyzed by measuring the fold increase over time of the appropriate cell lines according to predetermined standards (harvest to plant ratio) for rate of growth, density, atypical morphology, and evidence of cytotoxicity.
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