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COA/COQ

1.46779

Fluid K

Name: Fluid K
Brand: MM

ready-to-use, bottle volume 500 mL , filling volume

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Synonym(s):

Diluting Fluid K, Fluid K for Sterility Testing, Rinse Fluid, Rinsing Solution Fluid K, Washing Fluid

Agency

EP (2.6.13)
JP (4.06)
USP
(71)

Quality Level

300

description

Diluting or rinsing fluid for samples containing petrolatum/oil

sterility

sterile; autoclaved

form

liquid

shelf life

12 mo.

feature

closure type crimp cap with septum
ready-to-use

packaging

pkg of 1000 mL (in 1000 mL bottle with crimp cap and septum)
bottle of

technique(s)

microbiological culture: suitable
sterile filtration: suitable

bottle capacity

500 mL

bottle volume

500 mL , filling volume

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.

Storage Class Code

10 - Combustible liquids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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