Shampoo ANDAs are deceptively complex submissions. Unlike most topical generics, the formulation exists in three distinct physical states during use, each of which the FDA requires you to characterise independently.
At the Centre for Industrial Rheology, we leverage our specialised analytical experience and extensive suite of techniques to deliver a comprehensive Q3 characterisation package. We support you at every stage of your ANDA submission, with every dataset structured to support a direct comparison to the reference listed drug.
Table 1 – Techniques and Metrics Required for Shampoo ANDA Submissions
| Technique | Description |
|---|---|
| Rheology | Full flow curve characterisation, including shear stress and viscosity vs. shear rate, plateau identification, and yield stress determination where plastic flow behaviour is observed |
| Dynamic Foam Analysis | Quantitative foam characterisation from generation through to complete collapse, including time to complete foam collapse, continuous foam volume over time, and bubble size distribution at multiple time points |
| Surface Tension | Pendant drop analysis providing precise surface tension measurements across the required sample states |
| Particle Sizing | Dynamic light scattering for sub-micron and nanoscale populations, and laser diffraction for broader size distributions where required |
| Specific Gravity | Measured using an oscillating U-tube digital density meter |
| pH | Reported as part of the full characterisation profile |
| Microscopy | High-resolution imaging at multiple magnifications |
Contact us to discuss characterising your samples for ANDA submissions
Q3 Characterisation Requirements for ANDA Submissions
The FDA’s guidance recognises that a shampoo behaves very differently depending on where it is in the application process. As-dispensed refers to the product as it leaves the bottle, foamed reflects the state in which it contacts the scalp during use, and the residual formulation is what remains on the scalp after the foam has fully collapsed. Table 2 summarises the characterisation requirements at each physical state.
Table 2 – Characterisation Requirements for Each Physical State for ANDA Shampoo Submissions
| Technique | As-dispensed | Foamed | Residual |
|---|---|---|---|
| Rheology | ✓ | ||
| Dynamic Foam Analysis | ✓ | ||
| Surface Tension | ✓ | ✓ | |
| Particle Sizing | ✓ | ||
| Specific Gravity | ✓ | ||
| pH | ✓ | ||
| Microscopy | ✓ | ✓ | ✓ |
The Challenges of Q3 Characterisation
Navigating the FDA’s product-specific guidance and performing the testing can be a complex task for topical shampoos. You have to deal with:
- Equipment procurement, setup, and operator training
- Method selection, sample handling, and experimental artefacts
- Results interpretation, presentation, and confidently defending findings against tough technical questions
Having supported many companies through the regulatory submissions process, we have extensive experience delivering robust, reliable data, giving you total confidence from start to finish. If the FDA raises any queries regarding the data we generate, our team provides full response support to keep your submission moving forward smoothly.
If you are preparing a topical shampoo ANDA submission, contact us to discuss how we can streamline your pathway to compliance.