Comparative Dissolution Profiling (CDP) vs Analytical Method Validation (AMV)

This article contains the Difference Between  Analytical Method Validation (AMV) and Comparative dissolution profiling (CDP)

Difference Between Comparative dissolution profiling (CDP) and Analytical Method Validation (AMV)

Comparative dissolution profile and Analytical method validation are two different processes in the pharmaceutical industry, both of those play essential roles in ensuring the quality and efficacy of pharmaceutical products. Here are the key differences between them:

What is mean by Comparative Dissolution profiling (CDP)?

Comparative dissolution testing is primarily conducted to assess the performance and consistency of different batches or formulations of a drug product. It aims to demonstrate whether various batches of the same drug product or different formulations release the active pharmaceutical ingredient (API) at a similar rate and to ensure that the drug’s therapeutic effect is consistent.

The primary focus of comparative dissolution testing is to compare the dissolution profiles of different drug products or batches to ensure they meet established specifications and are bioequivalent. This helps in assessing the interchangeability of generic and brand-name drug.

Key parameters in comparative dissolution testing include the rate at which the API dissolves in various media, the dissolution profiles, and the similarity factors between profiles of different batches or formulations.

Comparative dissolution testing is often required by regulatory agencies to support the approval of generic drug products, as it demonstrates the similarity in dissolution profiles between the generic and reference (brand-name) drugs.

Note :

In Comparative dissolution profiling (CDP) fit factors can be expressed by two strategies  : F1- Difference factor and F2 – Similarity factor . Two dissolution profiles to be considered similar and bioequivalent, F1 should be in between of 0 and 15 whereas F2 should be between in 50 and 100.

The f2 value must be between 50 and 100. If more than 85 per cent of the active substance is dissolved within 15 minutes in all tested batches, dissolution profiles are considered to be similar without the need to calculate the similarity factor

What is mean by Analytical Method Validation (AMV) ?

Analytical method validation is the process of demonstrating that an analytical method used to test pharmaceutical products is suitable for its intended purpose. This includes ensuring that the method is accurate, precise, specific, robust, and reliable. Analytical method validation is not limited to dissolution testing but encompasses various analytical techniques used in pharmaceutical quality control.

Analytical method validation aims to establish the credibility and reliability of a specific analytical method. It involves testing the method’s ability to accurately quantify or identify the drug’s API and related substances, as well as assessing its sensitivity, specificity, linearity, and precision.

Analytical method validation is a regulatory requirement for pharmaceutical companies to ensure that the methods used for quality control testing are scientifically sound and reliable. This is applicable to various analytical techniques like assay, Related substances, Residual solvents but not limited to dissolution testing.

Analytical method validation is a regulatory requirement for pharmaceutical companies to ensure that the methods used for quality control testing are scientifically sound and reliable. This is applicable to various analytical techniques like Assay, Related substances, Residual solvents and not limited to dissolution testing.

Different analytical Techniques having different Test parameters those are enlisted as below :

Analytical method validation parameter for :

Assay :

1. Specificity and System suitability
2. Forced Degradation
3. Linearity
4. Precision
5. Accuracy
6. Solution stability
7. Robustness
8. Filter study

Dissolution : 

1. Specificity and System suitability
2. Linearity
3. Precision
4. Accuracy
5. Solution stability
6. Robustness
7. Filter study

Related Substances/Impurities:

1. Specificity and System suitability
2. Forced Degradation
3. Prediction of LOD and LOQ
4. Linearity
5. Precision
6. Accuracy
7. Solution stability
8. Robustness
9. Filter study

Residual Solvents:

1. Specificity and System suitability
2. Prediction of LOD and LOQ
3. Linearity
4. Precision
5. Accuracy
6. Robustness

Photostability : 

1. 1.2 Lux million hours in LUX light
2. 200 watt hours/square meter in Ultraviolet light