Analytical method validation establishes documented evidence that the procedure adopted for a test is fit for the intended purpose in terms of quality, reliability, and consistency of results. CD Formulation provides effective validation services of active pharmaceutical ingredients (APIs), excipients, and finished products required for development in oral thin film drug delivery systems, thereby reducing the cost, complexity, and overall timeline process of development.

Fig.1 Quality management requirements for innovative drug development. (PharmaBlock)

What is Analytical Method Validation?

Method validation is an evaluation process on the performance characteristics of an established analytical procedure through laboratory studies with all performance characteristics meeting the intended analytical applications. In other words, an analytical method should be examined from various aspects to prove that the test result of the analytical process can be trusted and appropriately applied to the intended quality objective.

What Types of Analytical Procedures Require Validation?

Analytical methods that affect the quality attributes of oral thin film products and directly or indirectly affect product quality or efficacy are usually included in the validation system. For example:

• Test methods for the identity of API
• Qualitative measurements for impurities/degradants
• Limit tests for impurities/degradants
• Quantitative assays of an API or drug product active material
• Physical product characteristics, e.g. dissolution rate

Our Oral Thin Film Analytical Method Validation Services

CD Formulation develops standardized verification procedures for oral thin film drug delivery systems by industry standards and regulatory guidelines. Our list of oral thin film available services includes but is not limited to:

Accuracy

The accuracy is determining how close the test result is to the true value of the analysis.

Precision

The precision is assessing the repeatability and intermediate precision of the method, including within-laboratory and between-laboratory variations.

Specificity

The specificity confirms that the method is selective and can accurately measure the analyte of interest in the presence of interferences.

Limit of Detection (LOD)

The LOD is a certain level (usually presented as concentration) set to determine how a method can distinguish the measured signal of the sample from the noise of the background matrix. It can be considered as an index of the limit test.

Limit of Quantification (LOQ)

The LOQ is the lowest concentration of sample (usually expressed as concentration) that can be determined by the method with acceptable precision and accuracy.

Linearity

The linearity is establishing the relationship between the analyte concentration and the response of the method over a specified range.

Range

The range is an interval of different analyte concentrations between lower and upper levels.

Robustness

The robustness of the method is an index of how a technique is capable of remaining stable under normal operation despite the existence of variation from the procedures.

Our Oral Thin Film Analytical Method Validation Steps

Fig.2 Oral Thin Film Analytical Method Validation Steps. (CD Formulation)

What Problem Can We Solve?

• Verify accuracy and precision to ensure consistency between measured values and true values.
• Establish linearity and range to ensure reliable quantification of different analyte concentrations.
• Determine the LOD and LOQ to assess method sensitivity.
• Establish system suitability criteria to ensure proper operation of analytical instruments.
• Test specificity and selectivity to accurately measure the oral thin film sample.
• Assess the robustness and durability to identify potential sources of variation for biological products.

Advantages of Our Oral Thin Film Analytical Method Validation

• We have extensive experience in analytical methods validation, including API, excipient, and oral thin film products.
• Our laboratory instruments are qualified, and we have a well-developed analytical methods validation documentation process.
• We have trained and qualified oral thin film analysts.
• We have reliable and stable reference standards.

Published Data

CD Formulation has extensive experience in the analytical method validation of oral thin film, whether you want to validate existing old methods or develop and validate new analytical methods, we provide professional technical support and services. If you require our oral thin film analytical method validation services, please contact us by phone or email, and our colleagues will get back to you within three working days.