Products and Packaging Validation
Residual solvent content, residual monomer content & identification and quantified endocrine disruptors
Residual solvent content
Residual solvents are determined using chromatographic techniques such as gas chromatography.
The toxicity and residual level of each solvent should be taken into consideration, and the solvents are limited according to defined principles and the requirements specified in Residual Solvents <467>.
Quality Guidelines Overview – Residual Solvent
- ICH Q3C (R4) Impurities: Guideline for Residual Solvents
- USP <467> Residual Solvents/Organic Volatile Impurities
Rescoll can help you to select an appropriate method to validate analytical procedures for your products or biomaterials according to ICH or USP guidelines.
Residual monomer content
The presence of residual monomers may result in toxicity effects. Residual monomers of complex polymeric materials can be identified using several techniques such as gas chromatography with a flame ionization detector (GC-FID) or gas chromatography coupled with mass spectrometry (GC/MS) and also high performance liquid chromatography (HPLC).
These analysis methods are useful for :
- Bioabsorbable polymers (PLA, PLGA, PCL)
- Methyl methacrylate (MMA)
- Products for the presence of Bis-phenol A (BPA)
Rescoll can help you to select an appropriate method to evaluate the residual monomer content according to the relevant guideline for your biomaterials or your medical devices.
Identification and quantified endocrine disruptors
(phthalates, brominated compounds, phenols, etc)
The presence of endocrine disruptors may cause toxicity effects and must be replaced in some cases. ANSES, EU and REACH Régulations are in agreement with this and will take action to reduce exposure to endocrine disrupting chemicals that may still be present in some products.
Endocrine disruptors can be identified and quantified using several techniques such as Soxlhet extraction and gas chromatography coupled with mass spectrometry (GC/MS).
Rescoll can help you to select an appropriate method to identify and quantify the endocrine disruptors present in your product according to the relevant guideline for your biomaterials or your medical devices.