产品说明
一般描述
Soybean Casein Digest Broth is a sterility medium and a critical component of our STERITEST® solution. Composition and growth performance of this medium comply with the European Pharmacopeia (EP) 2.6.1, United States Pharmacopeia (USP) 71 and Japanese Pharmacopeia (JP) 4.06. Our manufacturing approach ensures the highest level of quality for our media, improving accuracy and significantly reducing the risk of incorrect interpretation and false results. The appearance of the media is a light-yellow clear liquid. It has a pH of 7.3 ± 0.2 and the storage temperature is 2-25℃. The incubation temperature varies between 20-25℃, with an incubation time of 7-14 days. One box of product contains 12 bottles of 100ml of Medium. Each bottle has a screw cap with a septum, which minimizes the risks of cross-contamination and optimizes the disinfection procedures.
应用
Sterility testing (membrane filtration and direct inoculation)
Bioburden testing
Soybean-Casein Digest Medium is intended for the detection of aerobic bacteria and fungi. The QC organisms include Bacillus subtilis (ATCC 6633), Candida albicans (ATCC 10231), Aspergillus brasiliensis (niger) (ATCC 16404), Staphylococcus aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 9027). This medium is used for sterility testing by membrane filtration or direct inoculation. It is also used as a pre-enrichment broth for nonsterile products.
组分
装有隔膜的螺旋盖
产品规格
Incubation Temperature: 20–25 °C
Incubation Time: 7–14 days
美国药典、欧洲药典、日本药典
培养基
TSA
分析说明
混浊指示生长。
法律信息
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
基本信息
| eCl@ss | 32014001 |
| NACRES | NA.74 |
产品性质
| 质量水平 | 400 |
| agency | in accordance with EP 2.6.1 in accordance with JP 4.06 in accordance with USP 71 |
| 无菌性 | sterile; autoclaved |
| 形式 | liquid |
| 保质期 | 12 mo. |
| 特点 | ready-to-use |
| 包装 | pkg of 100 mL pack of 12 bottles |
| technique(s) | cell counting: suitable (total microorganisms) |
| 体积尺寸 | 100 mL |
| input | sample type pharmaceutical(s) |
| pH值(酸碱度) | 7.3±0.2 (25.0 ℃) |
| application(s) | pharmaceutical sterility testing |
| 相容性 | for use with Steritest® |
| 运输 | ambient |
| 储存温度 | 2-30℃ |
| 适用性 | nonselective for |
安全信息
| 储存分类代码 | 12 - Non Combustible Liquids |
| WGK | WGK 2 |
| 闪点(F) | Not applicable |
| 闪点(C) | Not applicable |
