You would like to analyse and characterise lyophilisates
What is a lyophilisate?
A lyophilisate is a solid product obtained by the lyophilisation process, also known as sublimation drying. This technique involves freezing a product (solution, suspension, extract, etc.) and then removing the water it contains in vapour form, without passing through the liquid state.
The result is a dry, porous, light substance that retains its chemical, biological or pharmaceutical properties.
Lyophilisates are particularly used to improve the stability, preservation and ease of transport of products that are sensitive to humidity or heat.
Guaranteeing the performance and conformity of your lyophilisation products
Why analyse lyophilisates?
Lyophilisation is a delicate process which has a direct impact on the quality, stability and efficacy of the final product. Carrying out a laboratory analysis makes it possible to :
Check product conformity : ensure that the lyophilisate meets the expected specifications in terms of structure, moisture content, concentration of active ingredient or absence of contaminants.
Guaranteeing stability over time : monitoring the development of the lyophilisate during stability studies (in accordance with ICH requirements), and anticipating any deterioration.
Checking the performance of the lyophilisation process : detect cycle faults (overheating, incomplete drying, etc.) or quality deviations that could affect product preservation or effectiveness.
Understanding a quality problem or non-conformity : in the event of a change in appearance, visible residue or instability, the analysis can identify the origin of the defect (particle, contamination, poor crystallisation, etc.).
The FILAB laboratory can help you analyse and characterise lyophilisates
Why choose FILAB for the analysis and characterization of lyophilisates?
Choosing FILAB to analyse your lyophilisates means choosing a laboratory with expertise in physico-chemical analysis, capable of characterising your products in detail: residual moisture, structure, purity, stability, contaminants.
Our state-of-the-art analytical facilities enable us to respond to all kinds of problems, from development to batch release.
We provide customised support, with an analysis plan tailored to your technical, regulatory or customer constraints.
our analysis services
Our resources
Organic chemical analysis
GC/MS, Py-GCMS, UPLC-MSMS, LC-QTOF-MS, LC-QTOF-MS, LC-ORBITRAP, GPC, NMR, FTIR
Powder analysis
XRD, SEM-FEG EDX, BET, Laser Granulometry
Mineral chemical analysis
ICP, XRD, IC
Thermal analysis
TGA, TGA-FTIR, DSC
Surface characterization
SEM-FEG EDX, XPS, TOF-SIMS
The QRM approach applied to lyophilisation
In a pharmaceutical context where sterility control is crucial, the analysis of lyophilisates in the laboratory is not limited to simple quality control: it forms an integral part of a Quality Risk Management (QRM) approach. As an open stage in the aseptic process, lyophilisation presents specific risks of contamination linked to the environment, cycle performance and container design. At filab, we combine high-precision physico-chemical and structural analyses (residual moisture, porosity, stability, contaminants, etc.) with a scientific approach focused on risk control. This complementary approach enables our customers to document, justify and ensure the reliability of their risk management strategy, within a framework that complies with the requirements of ICH Q9 and Annex 1 of the EU-GMP.
FAQ
A lyophilisate is a product that has undergone lyophilisation (or cryodessiccation), a low-temperature vacuum dehydration process that preserves the physico-chemical properties of a sample, often used in the pharmaceutical, cosmetics or food sectors.
Lyophilisate analysis is essential for :
- Check the regulatory compliance or quality of the finished product
- Check the stability of active substances
- Identify contaminants or impurities
- Characterize the physical properties of the freeze-dried product (porosity, hygroscopicity, homogeneity, etc.)
We carry out targeted investigations to identify the root cause:
- Texture problems (collapse, difficult rehydration, etc.)
- Chemical degradation
- Metallic or organic contamination
- Packaging non-compliance (migration, interaction, etc.)
Our team can intervene as a matter of urgency and suggest corrective measures to avoid a recurrence.
Yes, using GC-MS or the space head (HS-GC), we detect and quantify organic solvent residues present after freeze-drying, in accordance with ICH Q3C standards.
We can detect :
- Abnormal porosity or structural collapse
- Presence of agglomerates, stains or inclusions
- Cross-contamination (metallic, organic particles, etc.)
- Inhomogeneity of the active ingredient
Each defect may be correlated to a problem with the formulation or freeze-drying cycle.
