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Quality Control Specifications
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Lot-specific test results are listed 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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pH1
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Report results
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Osmolality2
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Report results
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Endotoxin3
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≤ 0.25 EU/mL @ 1:100
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Antimicrobial Activity4 (1:100)
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Inhibition of S. aureus & E. coli
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Pass
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- 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”.
- Measured using Minimal Inhibitory Concentration (MIC). At 100 CFU/mL, MIC must meet user concentration.
- Tested by a modified membrane filtration technique.
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