Low-endotoxin BSA is a highly purified, lyophilized powder. This product is processed to provide a minimum of 98% albumin and to have endotoxin levels ≤2.0IU/mg. It may be suitable for cell culture applications and for assays that require low endotoxin levels.
| SPECIFICATION - Bovine Serum Albumin - Low Endotoxin (BSA-LE) | |
| Product | Bovine Serum Albumin - Low Endotoxin |
| Catalogue No. | BSALE |
| Certificate of Suitability | Australia: R1-CEP 2005-191-Rev 00New Zealand: R1-CEP 2003-205-Rev 00 |
| Source | Bovine plasma from healthy animals inspected ante and post mortem by New Zealand or Australian Government veterinarians and passed as fit for human consumption |
| Collection/Processing Method | Cohn Fraction V Purified by heat shock treatment with charcoal treatment and diafiltrarion. |
| Description | Off white to pale green / yellow lyophilised powder |
| Stability | Stable for a minimum of 5 years under correct storage conditions |
| Storage | Store in sealed containers with a desiccant under dry conditions between 2 - 8°C |
| Analysis | Method | Range |
| pH | pH meter | 6.5 - 7.2 |
| Albumin | Gel Electrophoresis | ≥ 98% |
| Protein | LECO CF003.1 (dry basis) | ≥ 96% |
| Moisture Content | Oven Moisture Content | ≤ 5.0% |
| Chloride | Coulometric | ≤ 0.15% |
| Calcium | ICP-OES | ≤ 0.05% |
| Iron | ICP-OES | ≤ 0.002% |
| Magnesium | ICP-OES | ≤ 0.005% |
| Phosphorus, inorganic | Coulometric | ≤ 0.005% |
| Potassium | ICP-OES | ≤ 0.015% |
| Sodium | ICP-OES | ≤ 0.08% |
| Lead | ICP-OES | ≤ 0.003% |
| Ash Content | Gravimetric | ≤ 2.5% |
| Optical Density | Abs 405nm at 60mg/ml sol | ≤ 0.2 |
| Solubility | 60mg/ml sol. | Soluble |
| Bioburden | Heterotrophic Colony count - pour plate | ≤ 100 CFU/g |
| Endotoxin | Kinetic - Turbidimetric | ≤ 1.0 IU/mg |
EDQM
The European Directorate for the Quality of Medicines (EDQM) has originated from the European Pharmacopoeia Secretariat which, with the addition of new responsibilities changed its name to the European Department for the Quality of Medicines (EDQM). The EDQM sits alongside the European Medicines Agency (EMEA).
Amongst other activities, the EDQM is responsible for the European Pharmacopeia and the issuing of Certificates of Suitability (CEP).
Certificates of Suitability (CEP) are recognised by all signatory states of the European Pharmacopoeia Convention and by the European Union. Other countries have also chosen to recognise them. In the case of Fetal Bovine Serum and other Bovine Serum a CEP can be used by the manufacturers of Fetal Bovine Serum and other Bovine Serum which is intended for use in the manufacture of pharmaceutical products to demonstrate compliance with the Bovine Serum monographs of the European Pharmacopoeia and the EDQM requirements for substances concerned by TSE risk.
The discovery of Bovine Spongiform Encephalopathy (BSE), which is one of a group of similar infections now referred to as Transmissible Spongiform Encephalopathies (TSEs), and it’s spread over many countries of the European Union as well as its discovery in Canada, the USA and Japan is well known. The European events provided the impetus for the Council of Europe Public Health Committee (CEPHC) to pass Resolution AP-CSP (99) 5 addressing the TSE concerns and creating a Certificate of Suitability (COS) pursuant to Directive 75/318/EEC.
The granting of a CoS to a manufacturer, for a particular product, certifies that the product in question has been assessed for the level of risk of transmission of TSEs, and that the risk level is considered low enough that the product is certified as suitable for use in the manufacture of medicinal products in the European Union.
The process of approval requires the manufacturer to submit a dossier that covers all relevant aspects of the collection of raw material and further processing that is performed to reach the product that is offered to end users. This dossier is detailed and covers the specific material that is collected, the collection method, process validation, testing, traceability, quality systems and an expert review.
Only after this dossier has been examined and approved by two rapporteurs and, if necessary, by a panel of experts appointed by the European Directorate for the Quality of Medicines (EDQM) is the manufacturer granted a COS.
Moregate Biotech has been granted a COS for:
- Fetal Bovine Serum – Australian Origin – CEP2000-187
- Fetal Bovine Serum – New Zealand Origin – CEP2000-188
- Adult Bovine Serum - New Zealand Origin – CEP2001-093
- Adult Bovine Serum (Defibrinated) - New Zealand Origin – CEP2000-174
- Bovine Plasma – New Zealand Origin – CEP2003-199
- Bovine Serum Albumin – manufactured in Australia from New Zealand origin Bovine Plasma – CEP2003-205
- Bovine Plasma – Australian Origin - CEP 2005-192
- Bovine Serum Albumin – manufactured in Australia from Australian origin Bovine Plasma - CEP 2005-191
Copies of the Certificates of Suitability are available upon request
Hazards Identification
SPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT
- Not hazardous.
First Aid Measures
Get Medical attention immediately.
Inhalation
If inhaled, remove to fresh air. If breathing becomes difficult, call a physician
Ingestion
If swallowed, give several glasses of water to drink to dilute.
Skin Contact
Wash skin with soap and copious amounts of water.
Eye Contact
Flush with water for at least 15 minutes, lifting upper and lower eyelids occasionally.
Procedures for Personal Precaution
Exercise appropriate precautions to minimize direct contact with skin or eyes.
Methods for Cleaning Up
Mop up
Ventilate area and wash spill site after material pickup is complete
Fire fighting Measures
Extinguishing Media
Water spray. Carbon dioxide, dry chemical powder, or appropriate foam.
Special Risks
Emits toxic fumes under fire conditions
Special Protective Equipment for Firefighters
Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
Accidental Release
Procedures for Personal Precaution
Exercise appropriate precautions to minimize direct contact with skin or eyes.
Methods for Cleaning Up
Mop up
Ventilate area and wash spill site after material pickup is complete
Handling and Storage
Handling
Avoid contact with eyes, skin and clothing.
Storage
Keep tightly closed. Store at 2 - 8 °C.
Exposure Controls / Personal Protection
- Wash thoroughly after handling.
- Wear dust mask
- Protective gloves
- Chemical safety goggles
Disposal Considerations
Contact a licensed professional waste disposal service to dispose of this material.
Transport Information
- Non-hazardous for road transport
- Non-hazardous for sea transport
- Non-hazardous for air transport
Note: The above information is believed to be correct, but shall be used as a guide only.
Disclaimer: For pharmaceutical use only.
BOVINE SERUM ALBUMIN
Moregate Bovine Serum Albumin BSA is manufactured from Bovine Plasma of Australian or New Zealand origin in a well equipped facility located in Bulimba, Australia. The manufacturing process is a modified Heat Shock method.
The process includes ultrafiltration, micro filtration and freeze-drying.
Trained personnel following Standard Operating Procedures perform all operations. Each batch has a Manufacturing Record, which is reviewed after batch completion.
