What are the dissolution calibration parameters?

What are the dissolution calibration parameters?

Check the physical parameters for the each paddle like appearance, height, shaft diameter, blade upper chord, lower chord, height, radius (disk), thickness, and distance from bottom, distance shaft axis and vertical axis of vessel. All parameters should be fall within the limit as given in the calibration log.

Which standard is used for qualification of dissolution test apparatus?

Performance Qualification  Effectiveness of dissolution will be qualified by determining drug content in the solution.  For the comparison, solution of known concentration of USP Reference Standard is used.

Why prednisone is used for dissolution calibration?

Prednisone and Salicylic acid tablets USP were used for the calibration of dissolution test apparatus. Prednisone tablets were disintegration type and Salicylic acid tablets were non-disintegration type.

What is CV in dissolution?

The PVT acceptance criteria for geometric mean (GM) and coefficient of variation (%CV) are a measure for the trueness and precision of the results within the context of ISO 5725-6.

What is HPLC calibration parameters?

Know the procedure to calibrate the High Performance Liquid Chromatography ( HPLC) including leakage test, flow rate, reproducibility and linearity, lamp energy and pump pressure drop in Pharmaceutical Quality Control.

What is wobbling in dissolution?

Wobble is the movement from the centre line of a shaft or basket as it rotates. This causes a disruption in the flow profile in the vessel and can have a significant impact on dissolution rate. The measurement is made on the basket or paddle shaft close to the paddle blade or basket position.

Why do we use basket 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 wobble in dissolution?

What does Q stand for in dissolution?

The quantity, Q is the amount of dissolved active. Dissolution Medium—Proceed as directed for Immediate- ingredient. specified in the individual monograph, expressed Release Dosage Forms under Apparatus 1 and Apparatus 2.

What is RSD in dissolution?

Dissolution results may be considered highly variable if the relative standard deviation (RSD) is greater than 20% at time points of 10 minutes or less and greater than 10% RSD at later time points. 1 However, most dissolution results exhibit less variability than this.

How many types of dissolution are there?

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 to calibrate the Dissolution Apparatus?

Switch on the mains. Set the rpm to 50 as per procedure given in start up. Start the stirrer and measure the RPM either manually or by using a calibrated tachometer. Record the values. Similarly calibrate the Dissolution Apparatus for 100 and 200 RPM and record.

What is a calibration standard?

Calibration standards are devices that are compared against less accurate devices to verify the performance of the less accurate devices. The standard’s accuracy varies depending on what is being calibrated; most professionals recommend using a calibration standard that is at least four times more accurate than the device being calibrated.

What is the calibration standard operating procedure (SOP)?

This calibration Standard Operating Procedure (SOP) describes all the individual steps necessary for calibrating dissolution test apparatus type 1 (basket apparatus) and type 2 (paddle apparatus) in accordance with USP requirements and cGMP (current good manufacturing practices).

What is the procedure for calibration in ISO 9001?

Procedure for Calibration Using ISO 9001 Clause 7.1.5 of ISO 9001:2015 defines the requirements for calibration in ISO 9001 and is called Monitoring and Measuring Resources for ISO 9001. This standard does not provide the actual procedure for calibration but outlines the requirements an organization must follow.