Quality Level
material
glass bottle
agency
EP (2.6.13), JP (5.02), USP (62)
description
For the microbiological examination of non-sterile pharmaceuticals
sterility
sterile; autoclaved (tested for 14 days at 20-25°C and 30-35°C)
form
liquid
shelf life
360 days
feature
closure type Red screw cap with septum and protector, 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 bottles
technique(s)
direct inoculation: suitable, microbiological culture: suitable, sterile filtration: suitable
bottle capacity
250 mL
bottle filling volume
200 mL
color
clear colorless
pH range
6.8-7.2
application(s)
bioburden testing
food and beverages
pharmaceutical
storage temp.
2-25°C
suitability
nonselective for
General description
Buffered NaCl-Peptone solution has low peptone, along with phosphate buffer and sodium chloride that maintains the viability of micro-organisms in the solution without supporting further growth. The polysorbate 80 also assists in the suspension of hydrophobic substances. It further serves to neutralize disinfectants such as quaternary ammonium compounds, iodine, and parabens.
Application
Buffered NaCl-Peptone solution with 1% Tween® 80 is suitable for the microbial examination of non-sterile pharmaceutical products. It is also used as a solution for sample preparation or as a dilution or washing solution.
Features and Benefits
Our ready-to-use media provide the highest level of quality and testing confidence. They have been formulated and tested to meet the pharmacopeia requirements. Sterility testing media and rinse solutions are manufactured in an ISO 9001, environmentally controlled production center. Each lot undergoes a stringent quality control (QC) procedure, including pH, sterility, and growth promotion tests. Our manufacturing approach ensures the highest level of clarity for our media and rinsing fluids, thus improving accuracy and reducing the risk of incorrect interpretation and false results.
Analysis Note
The appearance of the medium is clear and colorless.
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
nwg
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 |
|---|---|
| 656402-250MG | 04061833483534 |
| 656402-1G | 04061826699218 |
| 1467810006 | 04061838830876 |