The standard dissolution test strip is a key tool for verifying the performance of dissolution testers and the standardization of experimental operations. Its selection needs to be determined comprehensively based on the instrument type, experimental purpose, and standard requirements. Currently, there are a total of standard tablets (particles) available for dissolution analyzer calibrationhave4There are salicylic acid tablets, prednisone tablets, chlorpheniramine maleate sustained-release tablets, and theophylline sustained-release tabletsgrain1Among them, the paddle method and basket method mainly use prednisone standard tablets (disintegrating type) and salicylic acid standard tablets (non disintegrating type), and the core difference between the two is their dissolution behavior: prednisone tablets will disintegrate under specified conditions, while salicylic acid tablets dissolve in a non disintegrating form.

Applicable scenarios and experimental requirements for different standard films

Prednisone standard tablets (disintegrating type)

Applicable scenarios:Mainly used for performance confirmation of paddle and basket methods, especially suitable for scenarios where the impact of disintegration behavior on dissolution needs to be investigated.

Example of experimental conditions（withR05991For example, batch:

Dissolving medium:High purity water is boiled, filtered, and degassed, and the temperature needs to be maintainedIn37±0.5℃.

Speed:50turn/Minutes, volume of dissolution mediumfor500ml/Cup.

Preparation of reference standard:Weigh prednisone reference substanceabout25mgAfter ethanol assisted dissolution, dilute to volume with dissolution medium to achieve concentrationfor10Mg/ml.

Data processing:By calculatingcalculateGMValue (geometric mean)andCVCompare the value (coefficient of variation) with the dissolution range specified in the standard sheet manual to determine whether the instrument performance is qualified.

Salicylic acid standard tablets (non disintegrating type)

Applicable scenarios:It is commonly used in domestic laboratories for daily performance confirmation of dissolution instruments, with relatively low requirements for water quality and instrument accuracy.

Example of experimental conditions（with100103-201512For example, batch:

Dissolving medium:Phosphate buffer solution（pH=7.4±0.05）Heating is requiredto45℃After vacuum filtration and degassing, the dissolved oxygen content should not exceedpass2.8mg/L.

Measurement method:Using UV visible spectrophotometry, measure the absorbance at a specific wavelength and calculate the dissolution amount

Key considerations for selecting standard films

1. Instrument type and cup configuration

For allocationplace12/14The dissolution apparatus of the cup can be directly used for single-stage experiments；8Cup and below instruments need to be validated through a two-stage experiment (measuring in stages and merging data)1.

2. Objective of the experiment

Daily calibrationPriority should be given to salicylic acid standard tablets (commonly used domestically and easy to operate)1.

Precision verificationIf examining disintegration behavior or compliance with international standards, prednisone standard tablets can be used1.

3. Regulatory and standard requirements

Required symbolscombine, synthesizeUSPTheEPorChPConfirm the dissolution range according to pharmacopoeia standards