Quality Level
agency
EP 2.6.13, JP 5.02, USP 62
sterility
sterile; autoclaved (tested for 7 days at 20-25°C)
form
liquid
shelf life
360 days
feature
closure type Red screw cap with 3 loci, ready-to-use
composition
KH2PO4, 3.6 g , NaCl, 4.3 g , Na2HPO4 x 2 H2O, 7.2 g , Peptone, 1 g , Tween®, 1% , Tween® 80, 10 mL
packaging
pack of 6 × 500 mL each, pack of 6 bottles
technique(s)
direct inoculation: suitable, sterile filtration: suitable
bottle capacity
500 mL
bottle filling volume
500 mL
pH range
6.8-7.2
application(s)
bioburden testing
pharmaceutical
storage temp.
2-25°C
suitability
nonselective for
General description
Sodium Chloride peptone buffer with 1% Tween® 80 is designed as a general diluent used for microbial examination of non-sterile pharmaceutical products. The low peptone concentration maintains viability without promoting growth. Presence of Sodium chloride maintains the osmotic balance of the medium and ensures cell integrity.
The neutral pH range is optimum for the viability of microorganisms′ present. The medium aims at maximum recovery of microorganisms present in the test sample.
The addition of Tween® 80(polysorbate) assists the suspension of hydrophobic substances and helps neutralize disinfectant agents like quaternary ammonium compounds, iodine, and parabens.
The neutral pH range is optimum for the viability of microorganisms′ present. The medium aims at maximum recovery of microorganisms present in the test sample.
The addition of Tween® 80(polysorbate) assists the suspension of hydrophobic substances and helps neutralize disinfectant agents like quaternary ammonium compounds, iodine, and parabens.
Application
Sodium Chloride peptone buffer with 1% Tween® 80 is used for microbial examination of non-sterile pharmaceutical samples. Additionally, the product can be used for dilution, washing solution and sample preparation.
Other Notes
Production will take place at Millipore SAS in Molsheim, France. Deliveries will be executed in accordance with the terms and conditions of MLS RTU GmbH. A minimum order quantity is required to process the order. Once the order is placed and confirmed, Merck will ensure product delivery within a maximum timeframe of 10 to 12 weeks. The terms and conditions of Merck KGaA apply to both Millipore SAS and MLS RTU GmbH and can be accessed through the following link: Standard Terms & Conditions
This medium can be modified and/or supplemented based on the required performance criteria.
Legal Information
TWEEN is a registered trademark of Croda International PLC
Disclaimer
This item is created at the customer′s request as a customized product and will not be developed or qualified in accordance with the Merck Product Development Process.
存储类别
12 - Non Combustible Liquids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
新产品
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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| 1466980006 | 04027269699963 |