Laboratory analysis and characterization of lyophilisates

Chemical analysis Problem solving R&D support
More than 140 people
More than 140 people at your service
5200 m² laboratory
5200 m² laboratory + 99% of services are provided in-house
Accredited laboratory
Accredited laboratory COFRAC ISO 17025

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 freeze-dried products

Freeze-drying is a critical stage in the development and conservation of many products, particularly in the pharmaceutical industry. This process ensures the stability, integrity and durability of your sensitive formulations. But how can you ensure that your lyophilisates retain all their functional properties after processing? Laboratory analysis and characterisation are essential.

Why analyse lyophilisates?

Freeze-drying 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.

Contrôler la performance du procédé de lyophilisation

Detect cycle faults (overheating, incomplete drying, etc.) or quality deviations that could affect product preservation or effectiveness.

Guaranteeing stability over time

Monitoring the development of the lyophilisate during stability studies (in accordance with ICH requirements), and anticipating any deterioration.

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 techniques

Organic chemical analysis

GC/MS, Py-GCMS, UPLC-MSMS, LC-QTOF-MS, LC-QTOF-MS, LC-ORBITRAP, GPC, RMN, IRTF

Powder analysis

XRD, SEM-FEG EDX, BET, Laser Granulometry

Mineral chemical analysis

ICP, DRX, CI

Thermal analysis

ATG, ATG-FTIR, DSC

Surface characterization

MEB-FEG EDX, XPS, TOF-SIMS

The QRM approach applied to freeze-drying

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, freeze-drying 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.

The filab advantages
A highly qualified team
A highly qualified team
Responsiveness in responding to and processing requests
Responsiveness in responding to and processing requests
A COFRAC ISO 17025 accredited laboratory
A COFRAC ISO 17025 accredited laboratory
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
A complete analytical park of 5,200m²
A complete analytical park of 5,200m²
Tailor-made support
Tailor-made support
Anaïs DECAUX Customer Support Manager
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