What is USP apparatus?
USP Apparatus 3 (reciprocating cylinder) is a very versatile device for the in vitro assessment of release characteristics of solid oral dosage forms, because it enables the product to be subjected to different dissolution media and agitation speeds in a single run.
What is dissolution Apparatus 1?
Adopted in 1970 the rotating basket method of dissolution testing was the first official method. The apparatus consists of a metallic drive shaft connected to the cylindrical basket. The basket is positioned inside a vessel made of glass or other inert, transparent material.
What is USP dissolution test?
A dissolution experiment evaluates the rate and extent that a compound forms a solution under carefully controlled conditions. The dissolution test in a USP drug product monograph helps evaluate the performance of a drug product (article) and indicates when the drug product performs in a substandard fashion.
What are the types of dissolution apparatus?
Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.
How many dissolution apparatus are in USP?
General chapter <711> Dissolution includes 4 standardized apparatus: basket, paddle, reciprocating cylinder, and flow-through cell. Where specified in a monograph, USP dissolution tests are legal requirements.
Why is basket apparatus used in dissolution?
This apparatus is called a basket. It is cylindrical in shape and is constructed from non-reactive mesh to prevent any unwanted chemical reactions that may alter the final result. The pores in the mesh allow the dissolving drug to move from the basket into the holding vessel, creating a uniform solution.
What is S1 and S2 in dissolution?
The dissolved amount of each unit in S1 stage should not be less than Q+5%. It shows that each product should exceed 5% of the dissolved amount specified in the individual Manograph. If any of the units falls below the limit, then we have to reanalyse the sample in the next stage. i.e. S2 stage.
What is dissolution limit?
The amount of dissolved active ingredient is known as Q in the dissolution test. The limit of Q may be different in different monographs according to the nature of the formulation and its active ingredients. Dissolution test is done using 6 units or dosage forms.
What is dissolution profile?
Dissolution Profile Behavior Rate of dissolution is a critical quality attribute of a pharmaceutical tablet. Tablet dissolution is typically studied by examining the form of the dissolution profile, which is the percentage of the tablet dissolved at various points in time.
How do you select rpm in dissolution?
The selection of RPM depends upon type of formulation, solubility characteristics of active substances and apparatus used for dissolution study. For capsules (both soft gel and hard gel), USP-I i. e. Basket apparatus is recommended, rotation speed for paddle shall be 50 to 75 RPM.
What is USP Apparatus II?
Drug Dissolution Apparatus II USP (Paddle) The paddle apparatus (Apparatus II) consists of a special, coated paddle that minimizes turbulence due to stirring. The paddle is attached vertically to a variable-speed motor that rotates at a controlled40 speed.