|
Defined Iron-Supplemented Bovine Calf Serum, US Origin, EMEA
Conforming
| Defined
Iron-Supplemented Bovine Calf Serum, US Origin, EMEA Conforming |
| SH30534.02 |
100 mL |
| SH30534.03 |
500 mL |
| SH30534.04 |
1000
mL |
|
Defined Iron-Supplemented
Bovine Calf Serum is collected by venipuncture from formula-fed
veal calves, which produce exceptionally high levels of transferrin.
We carefully supplement this serum with iron to load serum transferrin
levels to physiological levels. After supplementation, our Iron-Supplemented
Bovine Calf Serum contains three to four times as much available
iron and transferrin as FBS or equine serum. Many researchers have
found this product to be an excellent and cost-effective alternative
to FBS. Growth promotion studies have demonstrated the many applications
of Iron-Supplemented Bovine Calf Serum and show that it often out
per forms FBS in many applications. As with all our calf serum products,
this product is sterile filtered using three sequential 100 nm
(0.1 µm) pore-size rated filters..
HyClone recognizes
the challenges in changing regulatory filings, so we also offer
an option to those serum users who need to meet the human guideline
requirements, but prefer to continue using the same products (no
changes to the product part number) with the addition of three tests.
These products
are ordered using the non-EMEA part numbers and are tested per the
information below. Standard serum products that require EMEA/CPMP/
BWP/1793/02 conformance are provided with the standard Certificate
of Analysis, in addition to an addendum, which includes the additional
testing results. It is the combination of both documents that provide
assurance that the product purchased is EMEA/CPMP/ BWP/1793/02 Conforming.
|
| Endotoxin (Limulus Amebocyte Lysate - Gel Clot) |
<10 EU/mL |
| Hemoglobin (spectophotometric) |
<10 mg/dl |
| Sterility Testing Current USP & EP |
|
| Bacteria & Fungi |
No Growth |
| Virus Testing (9 CFR 113.53) |
|
| Flourescent Antibody |
|
| Bluetongue |
Not Detected |
| Bovine Adenovirus |
Not Detected |
| Bovine Parvovirus |
Not Detected |
| Bovine Respiratory Syncytial Virus |
Not Detected |
| Bovine Viral Diarrhea Virus |
Not Detected |
| Antibodies |
Pass |
| Interference/Comparative Titration |
No Interference |
| Quantitation |
Not Detected |
| Rabies |
Not Detected |
| Reovirus |
Not Detected |
| Bovine Leukemia Virus |
Not Detected |
| Cytopathogenic Agents - e.g IBR |
Not Detected |
| Hemadsorbing Agents - e.g. PI3 |
Not Detected |
| Mycoplasma |
|
| Large Volume, Direct Culture |
Not Detected |
| Hoechst DNA Stain |
Not Detected |
| Bovine Viral Diarrhea |
|
| Antibodies |
Not Detected |
| Interference/Comparative Titration |
Not Detected |
| Gamma Irradiation |
>30 kGy (>3.0 Mrad) |
| Post-Irradiation Testing |
|
| Antibodies |
Pass |
| Interference/Comparative Titration |
No Interference |
| Quantitation |
Not Detected |
| Certificate of Suitability |
Included |
|
| Defined
Iron-Supplemented Bovine Calf Serum, US Origin, EMEA Conforming |
| SH30072.02 |
100 mL |
| SH30072.03 |
500 mL |
| SH30072.04 |
1000
mL |
|
HyClone recognizes
the challenges in changing regulatory filings, so we also offer
an option to those serum users who need to meet the human guideline
requirements, but prefer to continue using the same products (no
changes to the product part number) with the addition of three tests.
These products
are ordered using the non-EMEA part numbers and are tested per the
information below. Standard serum products that require EMEA/CPMP/
BWP/1793/02 conformance are provided with the standard Certificate
of Analysis, in addition to an addendum, which includes the additional
testing results. It is the combination of both documents that provide
assurance that the product purchased is EMEA/CPMP/ BWP/1793/02 Conforming.
|
| Endotoxin (Limulus Amebocyte Lysate - Gel Clot) |
<10 EU/mL |
| Hemoglobin (spectophotometric) |
<10 mg/dl |
| Sterility Testing Current USP & EP |
|
| Bacteria & Fungi |
No Growth |
| Virus Testing (9 CFR 113.53) |
|
| Flourescent Antibody |
|
| Bluetongue |
Not Detected |
| Bovine Adenovirus |
Not Detected |
| Bovine Parvovirus |
Not Detected |
| Bovine Respiratory Syncytial Virus |
Not Detected |
| Bovine Viral Diarrhea Virus |
Not Detected |
| Rabies |
Not Detected |
| Reovirus |
Not Detected |
| Cytopathogenic Agents - e.g IBR |
Not Detected |
| Hemadsorbing Agents - e.g. PI3 |
Not Detected |
| Mycoplasma |
|
| Large Volume, Direct Culture |
Not Detected |
| Hoechst DNA Stain |
Not Detected |
| Certificate of Suitability |
Included |
| Sterility Testing (Current EP) |
|
| Bacteria & Fungi |
No Growth |
| Mycoplasma (per EP) |
|
| Large Volume, Direct Culture |
Not Detected |
| Hoechst DNA Stain |
Not Detected |
| Bovine Viral Diarrhea Virus(pre- & post- irradiation) |
|
| Interference/Comparative Titration |
Not Detected |
|
|