Certificate of Analysis

Transcription

1 Fetal Bovine Serum, Certified Origin: United States heat inactivated Performance, Mycoplasma, Virus, Bacteriophage and Endotoxin tested Catalog Number: Lot Number: Storage Temperature: -5 to -20C Expiration Date: For in vitro diagnostic use. SSterile filtered (triple 0.1 um) TEST SPECIFICATION RESULT UNITS 1 Alkaline Phosphatase Check & Record 228 u/l 2 Bacteriophage Testing Check & Record Negative 3 Bicarbonate Check & Record 13.0 MMOL/L 4 Bilirubin (Total) Check & Record 0.20 mg/dl 5 Blood Urea Nitrogen (BUN) Check & Record 15 mg/dl BUN/Creatinine Ratio Check & Record Calcium Check & Record mg/dl 7 Chloride Check & Record 95 MMOL/L 8 Cholesterol Check & Record 36 mg/dl 9 Creatinine Check & Record 2.40 mg/dl 10 Electrophoretic Pattern Normal Normal 11 Endotoxin Testing >=0 to <=5 <0.20 EU/mL 12 Gamma Glutamyl Transpeptidase (GGPT) Check & Record 4 u/l 13 Glucose Check & Record 109 mg/dl 14 Hemoglobin >=0 to <= mg% 15 High Density Lipoproteins (HDL) Check & Record 11 mg/dl 16 Hormone Profile: Estradiol Check & Record pg/ml 17 Hormone Profile: Insulin Check & Record 7.18 uiu/ml Page 1 of 5 Life Technologies

2 18 Hormone Profile: Progesterone Check & Record <0.05 ng/ml 19 Hormone Profile: Testosterone Check & Record <0.10 ng/ml 20 Hormone Profile: Thyroxine (T4) Check & Record ug/dl 21 Lactic Dehydrogenase (LDH) Check & Record 512 u/l 22 Low Density Lipoproteins (LDL) Check & Record 11.0 mg/dl 23 Mycoplasma, Supplemental (H-Stain) Negative Negative 24 Mycoplasma Testing Negative Negative 25 Origin Confirmation Passes Test Passes Test Pass = U.S. Origin 26 Osmolality >=280 to <= mosm/kg 27 Performance Testing: Cloning Assay Check & Record 106 % 28 Performance Testing: Growth Assay Check & Record 74 % 29 Performance Testing: Plating Assay Check & Record 86 % 30 ph >=6.9 to <= Phosphorous (Inorganic) Check & Record mg/dl 32 Potassium Check & Record MMOL/L 33 Serum Glutamyl Oxalactate Transaminase Check & Record 53 u/l 34 Sf-9 Performance Assay Check & Record 90 % 35 Sodium Check & Record 136 MMOL/L 36 Sterility Testing Negative Negative 37 Tetracycline None Detected None Detected 38 Total Iron Binding Capacity Check & Record 225 mcg/dl 39 Total Protein >=3.0 to <= g/dl 40 Transferrin Check & Record mg/dl 41 Triglycerides (TG) Check & Record 72 mg/dl 42 Uric Acid Check & Record 1.90 mg/dl 43 VT - Bluetongue Virus FA Negative Negative 44 VT - Bovine Adenovirus FA Negative Negative Page 2 of 5 Life Technologies

3 45 VT - Bovine Parvovirus FA Negative Negative 46 VT- BRSV Fluorescent Antibody Negative Negative 47 VT - BVDV Fluorescent Antibody Tested Tested 48 VT - Cytopathogenic Agents Negative Negative 49 VT - Hemadsorbing Agents Negative Negative 50 VT - Rabies Virus FA Negative Negative 51 VT - Reovirus FA Negative Negative Read SDS GIBCO brand, Life Technologies cell culture liquid products are prepared by an aseptic process for which each step has been validated to ensure that all products meet the industry standard sterility assurance level of 10^-3; i.e. product that demonstrates a contamination level of no more than 1 of 1,000 units during the manufacturing process. The highest level of sterility assurance (equal to or greater than 10^-6) cannot be achieved without terminal sterilization which is harmful to the performance of cell culture products. We certify that all Fetal Bovine Sera meets USDA requirements for abbatoir-sourced animals, traceability and country of origin. ABBATOIR-SOURCED ANIMALS: All fetal blood is collected from fetuses derived from healthy dams that have passed pre and post mortem certified veterinary inspection. TRACEABILITY: All Fetal Bovine Sera is traceable by date and location of collection. COUNTRY OF ORIGIN: Fetal Bovine Serum collected and processed in the United States is from USDA approved and inspected slaughter establishments. The United States is recognized by the USDA as being free of foot and mouth disease and rinderpest. NOTICE: Since our sera are not pre-aged before filtration, turbidity or flocculent debris may develop upon thawing or storage. This condition does not adversely affect performance characteristic of the serum. Parent Lot No. is Quality Systems Department Date: 20-Jan-2017 Page 3 of 5 Life Technologies

4 REFERENCES: 1 Bowers, McComb: Measurement of Total Alkaline Phosphatase activity in human serum, Clin Chem 21:1988, Bacteriophages (ed. Adams, M.H.) Interscience Publishers, Inc., New York, 1959 (Life Technologies Modified). 3 Direct potentiometry, ion selective electrode; Tietz (1986), and Henry (1974). 4 Diazonium salt, dual wavelength reflectance spectrophotometry; Tietz (1976) and Kuenzle, Maier, Ruttner (1964). 5 Urease catalyzed hydrolysis, colorimetric determination; Faulkner, King (1976). 6 Cresolphthalein Complexone; Tietz (1976). 7 Ion selective electrode (diluted). 8 Enzymatic (cholesterol esterase/oxidase/peroxidase); Allain, Poon, Chan: Enzymatic determination of total cholesterol in serum, Clin Chem, 20, 470, Rate-Blanked Compensated Kinetic Alkaline Picrate (Jaffe Reaction). 10 Protein Electrophoresis - Life Technologies Specifications 11 Current United States Pharmacopeia, <85> Bacterial Endotoxins Test. 12 L-Y-Glutamyl-4-nitroanalide/glycylglycine: Szasz (1969). 13 Hexokinase, UV; Tietz (1976). 14 Fleming, A.F. and Woolf, A.J. (1965) Clin. Chem. 12, Enzymatic Determination of Total Cholesterol in serum. 16 McCann, J.P. and Reimers, T.J. (1986) J. Anim. Sci. 62, 772. Modified by Cornell Endocrinology Diagnostic Laboratory, New York College of Veterinary Medicine, Ithaca N.Y Reimers, T.J., Cowan, R.G., McCann, J.P., Ross, M.W. (1982) Amer.J.of Vet. Res. 43:7, Reimers, T.J., McCann, J.P. and Cowan, R.G. (1983) J. Anim. Sci. 57, 683. Modified by Cornell Endocrinology Diagnostic Laboratory, New York College of Veterinary Medicine, Ithaca, N.Y Unpublished, Cornell Endocrinology Diagnostic Laboratory, New York College of Veterinary Medicine, Ithaca, N.Y Reimers, T.J., Cowan, R.G., Davidson, H.P., Colby, E.D. (1981) Amer.J.of Vet.Res.42:11, Pyruvate to lactate, NADH oxidation measured by reflectance spectrophotometry at 340 nm. 22 LDL=(cholesterol - HDL - (triglycerides/5)) 23 Hoechst H Stain Chen, T.R. (1977) Exp. Cell Res., 104, 255 Life Technologies Modified. 24 Barile, M.F. and Kern, J. (1971) P.S.E.M.B. 138, 432, Life Technologies Modified. 25 Acid digestion, ICP-MS and statistical modeling. 26 Life Technologies Specifications. 27 Life Technologies Specifications, Ref.: GIBCO Catalog. Cell Line Used: Sp2/O-Ag14 (ATCC No. CRL-1581) or P3 x 63 - Ag8.653 (ATCC No. CRL-1580). The cloning efficiency assay analyzes the ability of each FBS lot to support cloning and growth of murine myeloma cells and derived hybridomas. 28 Life Technologies Specifications, Ref.: Cell Line Used: Human Diploid Normal Lung Fibroblast. GIBCO growth promotion assay measures the ability of each FBS lot to support proliferation of fastidious human diploid fibroblasts through multiple subcultures. 29 Life Technologies Specifications, Ref.: GIBCO Catalog. Cell Line Used: Human Lung Carcinoma (A549), ATTC No. CCL-185. Analysis of cellular attachment and proliferation of a human transformed cell line. 30 Life Technologies Specifications. 31 Phosphomolybdate, UV; Tietz (1976). 32 Ion selective electrode (diluted). 33 Sodium Pyridoxal-5-phosphate-(malate dehydrogenase/nadh). Page 4 of 5 Life Technologies

5 REFERENCES: 34 Life Technologies Specifications. Cell Line Used: Spodoptera frugiperda (Sf9), ATCC No. CRL Sf9 cells are set up in shaker flasks at 2.75 x 10^5 cells/ml. Test samples are counted after 96 hours. Each new production lot is compared to a previously approved lot. The relative cell number must be equal to or greater than 80% of the control and the test sample viability must be equal to or greater than 80%. 35 Ion selective electrode (diluted). 36 Current edition of USP. 37 Life Technologies Specifications. Analysis of tetracycline in fetal bovine serum (FBS). Protein precipitation is performed on the FBS sample followed by a reverse phase HPLC separation of tetracycline from endogenous components of the protein free serum supernatant. The assay detects the presence of tetracycline in FBS at a part per billion level. 38 Stokey, L.L., (1970) Ferrozine, "A New Spectral Photometric Reagent For Iron." Analytical Chemistry 42, Tietz, Norbert W. : Biuret Method for the Determination of Total Protein in Serum and Exudates. Fundamentals of Clinical Chemistry, 1976, pages Ritchie. R.F., et al (1978) Automated Immunoanalysis Part I, Clinical Chemistry Biochemical Analysis Ser Vol: 7, Enzymatic (glycerol phosphate oxidase); Spayed, Multilayer film elements for clinical analysis, Clin Chem 24, , Uricase/allantoin; Kageyama, A direct colorimetric determination of uric acid in serum and urine with uricase catalysts system, Clin Chem Acta 31, 421, 1971; Trivedi, Rabar, Berta, New enzymatic method for serum uric acid at 520nm, Clin Chem 24, , Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. 44 Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. 45 Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. 46 Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. 47 Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. 48 Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. 49 Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. 50 Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. 51 Virus Testing (VT) is performed according to the Code of Federal Regulations, (CFR), Title 9, Part (c) [113.46, ]. Page 5 of 5 Life Technologies