1.46779
溶液K - 即用型冲洗液
bottle capacity 500 mL, bottle filling volume 500 mL, closure type, Blue flip cap with septum, pack of 6 bottles
别名:
Diluting Fluid K, Fluid K, Fluid K for Sterility Testing, Rinse Fluid, Rinsing Solution Fluid K, Washing Fluid
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UNSPSC Code:
41106214
Bottle capacity:
500 mL
Bottle filling volume:
500 mL
Feature:
closure type Blue flip cap with septum, ready-to-use
Agency:
EP (2.6.13), JP (4.06), USP
(71)
(71)
Ph:
6.7-7.1
material
glass bottle
Quality Level
agency
EP (2.6.13), JP (4.06), USP
(71)
sterility
sterile; autoclaved (tested for 14 days at 20-25°C and 30-35°C)
form
liquid
shelf life
180 days
feature
closure type Blue flip cap with septum, ready-to-use
composition
Beef Extract, 3 g , Peptic Digest of Animal Tissue, 5 g , Tween® 80, 10 g
packaging
pack of 6 bottles
technique(s)
microbiological culture: suitable, sterile filtration: suitable
bottle capacity
500 mL
bottle filling volume
500 mL
color
clear slightly to yellowish
pH
6.7-7.1
application(s)
pharmaceutical
sterility testing
compatibility
for use with Sterility Testing
storage temp.
2-25°C
suitability
nonselective for bacteria
General description
Fluid K is designed as a washing solution for sterility testing of petrolatum solutions or oil-soluble pharmaceutical products using the membrane filtration method. Post filtration, the membranes are rinsed with Fluid K, whose composition also supports the growth of microorganisms upon incubation.
Application
Fluid K is suitable for sterility testing of petrolatum products or oil-soluble pharmaceutical products. The washing solution serves as a medium for the growth of microorganisms in test samples. The fluid is also excellent for rinsing pathways of medical devices and products that are difficult to filter or dissolve.
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 slightly yellowish.
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.
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存储类别
12 - Non Combustible Liquids
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| 1467790006 | 04061838830852 |