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- FEDGAS High-Fat Meal
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PRODUCT DESCRIPTION
FEDGAS High-Fat Meal dissolution media simulate gastric fluids after a high-fat FDA meal. 900ml of medium (the volume we recommend using per dissolution vessel) contains the 62.5g of fat and 62.5g of carbohydrate present in a partially digested meal.
Fluids from three different stages of stomach emptying are simulated: Early, Mid and Late.
Testing in these three media will reveal the dissolution of your drug in gastric fluids after a high-fat FDA meal.
- Preparation is simple and instant with buffer included for ease of use
- Each pack produces 6 x 900ml of dissolution medium
- Suitable for all types of drugs (acid, base, neutral, salt)
- Compatible with USP Apparatus 1 or 2 and standard HPLC analytical equipment
- Easy to filter so avoids the need for time consuming separation techniques
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Preparation
FEDGAS™ Preparation Instructions
FEDGAS™ dissolution media simulate human stomach fluids in the fed state. You should use 900mL per dissolution vessel: this contains the amount of fat and carbohydrate present in a high-fat FDA meal. FEDGAS is available at 3 different pH values: 6, 4.5 and 3 (each sold separately).
Equipment
- Calibrated balance
- Suitable container
- Stirrer plate and PTFE magnet
Method
To make 900mL of FEDGAS pH6:
- Weigh 36.8g of FEDGAS Buffer Concentrate (pH6) into a suitable container
- Add 732.6g of purified water
- Add 153.0g of FEDGAS gel
- Stir until mixed thoroughly. The medium will be white like milk and is ready to use
To make 900mL of FEDGAS pH4.5:
- Weigh 36.8g of FEDGAS Buffer Concentrate (pH4.5) into a suitable container
- Add 730.8g of purified water
- Add 153.0g of FEDGAS gel
- Stir until mixed thoroughly. The medium will be white like milk and is ready to use
To make 900mL of FEDGAS pH3:
- Weigh 36.8g of FEDGAS Buffer Concentrate (pH3) into a suitable container
- Add 729.9g of purified water
- Add 153.0g of FEDGAS gel
- Stir until mixed thoroughly. The medium will be white like milk and is ready to use
Usage
- We recommend using FEDGAS dissolution medium at 37⁰C. It can be used for up to 24 hours at this temperature
- Store the FEDGAS gel pouch in the refrigerator and use within 7 days of opening
- Store the FEDGAS buffer bottle at room temperature
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TECHNICAL INFO
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SDS/COA
