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Jan. 02, 2019

USP basket specifications and inquiry links: Dissolution basket

USP dissolution sinker specifications and inquiry links: Dissolution sinker

 

Preface:

The main content of this blog:


1. Advantages of ZHEHAN USP basket

2. Basket method for dissolution test

3. The Use of USP basket and Dissolution sinker

 

Keywords in this blog: Dissolution test, USP basket, Dissolution sinker, Dissolution basket

 

ZHEHAN is a well-known USP basket and USP dissolution sinker manufacturer in China. The product page has its detailed specifications. Here I mainly introduce the advantages of our products.

 

Advantages of ZHEHAN USP basket

 

1. Quality&Price

Detailed information is available on the product page, which is not shown here.

 

2. Delivery speed

We have a large stock of conventional products. We can deliver the goods within a week.

We need special customized products. Finish the drawings in one hour.

 

3. High coaxiality

 

4. Patent technology

Our unique process can increase the corrosion resistance of the product by 45% without blackening in hydrochloric acid or sulphuric acid.

 


Dissolution test and USP basket


 

Dissolution and Release Measurements Dissolution refers to the rate and degree of dissolution of active drugs from tablets, capsules or granules under specified conditions, it is also known as release rate in sustained-release, controlled-release, enteric-coated and transdermal patches.

 


Basket method - USP basket


 

- USP basket

 

The USP basket system is divided into two parts: the basket body and the basket axis. Made of stainless steel or other inert materials.

 

- Dissolution cup

 

The vessel is typically a hemispherical 1000ml cup-shaped container made of hard glass or other inert material. The inner diameter of the soil is 102 mm +/- 4 mm (the difference between the maximum inner diameter of the cylinder and the minimum inner diameter should not be greater than 0.5 mm). The height is 185 mm (+25 mm).

 

The dissolution cup is fitted with a suitable lid with proper holes in the lid. The center hole is the position of the basket axis, and other holes are used for sampling or temperature measurement.

The dissolution cup is placed in a constant temperature water bath or other appropriate heating devices.

 

- Basket axle is connected with the motor, and the speed of the motor is controlled by speed regulating device so that the speed of basket axle is within 4% of the specified speed under each variety.

During operation, the whole set of devices should be kept stable, and no obvious shaking or vibration (including the environment in which the device is located) can be produced.

 

When the basket rotates, the deviation between the vertical axis of the basket and the dissolving cup should not be greater than 2 mm at any point, and the swing amplitude of the lower edge of the basket should not deviate from 1.0 mm of the axis.

 

- The instrument is usually equipped with more than 6 sets of measuring devices.

9.75+0.35 Fig. 3 Small cup agitator device Fig. 4 Small cup dissolution cup device Fourth method (Paddle disc method 1 agitator, dissolution cup according to the second method, dissolution cup put people in the stainless steel mesh dish for placing patches (Fig. 5).

 

In this process, the USP basket is indispensable.

For pharmaceutical manufacturers, it is very important to use a high-quality USP basket.

 


Determination method - USP basket


 

Before measurement, the necessary adjustment should be made to make the bottom of the basket or blade away from the bottom of the beaker 25 mm (+2 mm) from the bottom of the dissolving cup.

 

The deviation between the actual volume and the prescribed volume should be within (+) 1%. After the temperature of the dissolving medium is constant at 37 (+) 0.5 (+) C, 6 pieces (granules and bags) of the sample are taken.

 

- For the first method, six dried revolving baskets are put into the dissolving cup, and the revolving baskets are lowered into the dissolving cup.

- For the second method, put in 6 dissolving cups, respectively.

(When the dissolution sinker is required under each category, the capsule can be loaded into the dissolution sinker.

It is not stipulated that when using dissolution sinker if the capsule is floating on the liquid surface, a small piece of corrosion-resistant fine wire can be used to lightly wrap around the capsule shell.)

Care should be taken to avoid air bubbles on the surface of the sample and to start the instrument immediately according to the speed specified under each variety.

Up to the prescribed sampling time (the difference between the actual sampling time and the prescribed time must not be less than (+2%) and the appropriate amount of leachate should be absorbed (the sampling position should be from the top of the basket or blade to the midpoint of the liquid surface, 10 mm from the inner wall of the leachate cup);

 

When multiple sampling is required, the volume of the dissolving medium should be 1% of that of the dissolving medium.

 

If the result is judged to meet one of the following conditions, it may be judged to be in conformity with the provisions.

 

(1) Among the six tablets (granules and bags), the dissolution of each tablet (granules and bags) is calculated according to the labeled amount and is not less than the prescribed limit (Q).

(2) Among the 6 tablets (granules and bags), if 1-2 tablets (granules and bags) are lower than Q, but not less than Q-10% and the average dissolution amount is less than Q.

(3) Among the 6 tablets (granules and bags), 1-2 tablets (granules and bags) were lower than Q, and only 1 tablet (granules and bags) was lower than Q-10%, but not less than Q-20%. When the average dissolution amount of Q, another 6 tablets (granules and bags) should be taken for re-examination.

(4) Among the 12 tablets (granules and bags) tested at the beginning and the second time, 1-3 tablets (granules and bags) were lower than Q, and only 1 tablet (granules and bags) was lower than Q-10%, but not less than Q-20% and the average dissolution rate was less than Q-20%.

The 10% and 20% of the results indicated above refer to the percentage (%) relative to the quantity indicated.

 

Dissolution conditions and precautions

 

1) The applicability and performance confirmation test of the dissolution meter should not only meet the above requirements but also apply the dissolution standard sheet to perform the performance confirmation test of the instrument. The test results should conform to the requirements of the standard sheet according to the instructions of the standard sheet.

2) Dissolution medium. The dissolving media specified under each category shall be used, with a volume of 900 ml at room temperature, unless otherwise specified, and shall be freshly prepared and degassed; if the dissolving medium is a buffer solution, the pH value shall generally be adjusted within <0.05 when the pH value needs to be adjusted.

3) The sampling time should be in accordance with the sampling time stipulated in the varieties, and the sampling time from 6 cups should be within 1 minute.

4) Except as otherwise specified, the dosage of granules or dry suspensions should be dispersed on the surface of the dissolving medium to avoid centralized dosage.

5) If the capsule shell interferes with the analysis, no less than 6 capsules should be taken. After the contents are exhausted, the capsules should be placed in a dissolution cup. The average value of empty capsules should be determined according to the analysis method prescribed under this variety, and necessary corrections should be made. If the calibration value is more than 25% of the labeled value, the test is invalid. If the correction value is not more than 2% of the labeled quantity, it can be neglected.

 

That's all for today.

 

If you are interested in our settling basket, please leave us a message.


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