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Quality Control Specifications
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Sterility tests are performed on each lot of fetal bovine serum using current USP and EP methods. Specific tests for contaminants are listed below in the Specification Certificate. This serum is tested for ability to support the growth and maintenance of embryonic stem cells in an undifferentiated state. Undifferentiated embryonic stem cells are determined by colony morphology and expression of three pluripotent markers. The results are compared to a control lot of serum. The serum is triple filtered through 0.1 μM filters and each lot of fetal bovine serum is tested for sterility.
Origin
This fetal bovine serum is manufactured from fetal bovine blood collected in USDA-inspected abattoirs located in the United States.
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Test*
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Specification
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Sterility Testing (Current USP and EP)
Bacteria and Fungi
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No growth
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Virus Testing (9 CFR 113.53)
Fluorescent antibody
Bluetongue
Bovine Adenovirus
Bovine Parvovirus
Bovine Respiratory Syncytial Virus
Bovine Diarrhea Virus
Rabies
Reovirus
Cytopathogenic Agents (e.g. IBR)
Hemadsorbing Agents (e.g., PI3)
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Not detected
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Mycoplasma Testing
Large volume, direct culture Hoechst DNA stain
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Pass
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Endotoxin (Limulus Amebocyte Lysate -Gel Clot)
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≤ 10 EU/mL
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Hemoglobin (Spectrophotometric)
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Report result
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Growth Promotion
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Pass
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ES Cell Testing
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Pass
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*Please consult the Certificate of Analysis for lot-specific test results.
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