技术规格说明书
产品名称
胎牛血清 γ-irradiated, USA origin, sterile-filtered, suitable for cell culture, suitable for hybridoma
产品编号
f3885
产品品牌
sigma
化学文摘社编号
分子量
Test皿 | 规格 |
|---|---|
| Mycoplasma | None detected (Broth Culture) |
| Osmolality | 260 - 340 mOsm/kg H2O |
| AVA (9CFR113.53) | Bovine Adenovirus (type 3 and 5) -,None detected |
| Bovine Parvovirus - None detected | |
| Blue Tongue Virus - None detected | |
| BVDV by FA - None detected | |
| Cytopathic Effect - None detected | |
| Hemadsorption - None detected | |
| Infectious Bovine Rhinotracheitis - None,detected | |
| Parainfluenza 3 - None detected | |
| Rabies Virus - None detected | |
| Reovirus - None detected | |
| Bovine Respiratory Syncytial Virus -,None detected | |
| Vesicular Stomatitis Virus -,None detected | |
| Bacteriophage Testing | Record (PFU/mL) |
| Total Protein | 3.0 - 4.5 g% |
| Chemical Analysis | Cholesterol - Report result |
| Hormone Level | Estradiol - Report result |
| Chemical Analysis | Iron - Report result |
| Gamma Glutamyl Transferase - <10 IU/mL | |
| Glucose - Report result | |
| Hormone Level | Insulin - Report result |
| Chemical Analysis | Sodium - Report result |
| Hormone Level | Progesterone - Report result |
| Sterility per current USP | Negative |
| Hormone Level | Testosterone - Report result |
| Tetracycline | Report Result |
| Chemical Analysis | Triglyceride - Report result |
| Serum Antibody Titer - BRSV | Report result |
| Serum Antibody Titer - BVDV | Report result |
| Serum Antibody Titer - IBR | Report result |
| Serum Antibody Titer - PI3 | Report result |
| Cloning Assay | Pass |
| Mycoplasma | None detected (DNA Fluorochrome Stain) |
| Insect Cell Culture Test | Pass |
| Cell Lines | Record cell lines used |
| pH | 6.7 - 8.0 |
| Bovine IgG | <= 1 mg/mL |
| Endotoxin | <= 10 EU/mL |
| Serum Performance Test | Pass |
| Cell Lines | Record Cell Lines Used FIO |
| Hemoglobin | <= 20 mg% |
| Electrophoretic Profile | Albumin - Report result |
| Alpha 1 Globulin - Report result | |
| Alpha 2 Globulin - Report result | |
| Beta Globulin - Report result | |
| Gamma Globulin - Report result | |
| Irradiation Certificate | Present |
| Irradiation Date | Date of Irradiation |
| Irradiation Dosage | 25.0 - 40.0 kGy |
| Country of Origin | Record |
| Appearance | Clear light straw to dark amber colored,liquid |
| COMMENTS | |
| Intended Use | For R&D use only. Not for drug, household, or other uses. |
| Storage | Store at -20 C |
| Extended Item Desc. | Fetal Bovine Serum |
| Gamma Irradiated by | |
| SER-TAIN (TM) Process | |
| Sourced in USA | |
| Origin | The material used in this product was collected in the United States. |
| Animals used for collection of serum were USDA inspected and acceptable | |
| for slaughter. | |
| C of A comments | Country of final product processing: United States |
| This product was gamma-irradiated at 25 - 40 kGy as part of a | |
| validated process for the inactivation of biological extraneous | |
| agents. This product remained in a frozen state at the time of | |
| irradiation and during the transportation process. Certificate(s) of | |
| Irradiation for this lot of material is/are attached to document the | |
| treatment. Due to processing constraints, more than one Certificate | |
| of Irradiation may result; however, all processing is verified to be | |
| within the validated dose range. | |
| Label Requirements | DOM: N EXP: Y Format MM/YY |
| Expiration Notes for FG | Expiration Date: 60 months from date of manufacture |
| Stop Lot Date: 58 months from date of manufacture | |
| Label Requirements | Expiration date on the Sigma label is in MM/YY format. As an example: |
| if material expires 31AUG12 the expiration date on the label will be | |
| listed as 08/12. | |
| Use Sigma label stock. Reference F2442 master approved labels. | |
| Misc. | Expiration date for SAFC/BPCS purposes is the last day of the month. As |
| an example: 31AUG12 | |
| Create both a BPCS generated COA and a SAP generated COA. | |
| If the insect cell culture test (C402A) does not pass advise Serum Product | |
| Manager. | |
| Specification | F3885.000000002 |
| Approval Date | 6/15/2022 |