1.46469

Fluid D acc. USP

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

• Synonym(s): Washing Fluid, Rinse Fluid
• UNSPSC Code: 41106200
• NACRES: NA.74

Properties

• Agency: USP 71
• Quality Level: 300
• description: 500 ml rinsing fluid in 500ml bottle with screw cap and septum; suitable for sterility testing
• sterility: sterile; autoclaved
• shelf life: 12 mo.
• feature: closure type screw cap with septum; ready-to-use
• packaging: pkg of 500 mL; bottle of
• technique(s): sterile filtration: suitable
• bottle capacity: 500 mL
• bottle volume: 500 mL , filling volume
• pH: 7.1 ( in H₂O); 7.1
• application(s): cosmetics
• storage temp.: 2-25°C

Description

General description

Fluid D is a washing solution for sterility testing of pharmaceutical samples containing lecithin or oil using the membrane filtration method. Rinse the membrane with Fluid D after filtration and provide a suitable medium to observe microbial growth.

Application

Fluid D is suitable for rinsing the solutions containing oil or lecithin during sterility testing by membrane filtration.
The oil should penetrate the membrane by its own weight followed by filtering applying the pressure or suction gradually. The membrane may be washed 3 times with 100 ml Fluid D (Fluid A with 0.1% Tween^® 80) afterwards. At least one or one half of the filter is incubated in Tryptic Soy Broth (e.g. article number 146458) and a second or the other half of the filter in Fluid Thioglycollate Medium (e.g. article number 146385) for not less than 14 days.

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.

Legal Information

TWEEN is a registered trademark of Croda International PLC

Safety Information

• Storage Class Code: 10 - Combustible liquids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable