20 years of
helping you
in your development
and quality control
Packaging
ICH Q3D
Nitrosamines
Analyses RMN
Titrage antibiotiques
VALIDATION OF YOUR PACKAGING
- Expertise and customized monitoring
- A single site for storage and leading tests
- Large storage capacity and diversity of climatic conditions
A comprehensive container-content study requires evaluating stability ofthe product in its packaging:
We check compliance of your raw materials (plastic, lubricants, etc.) used for manufacturing your packaging with the different Pharmacopeia. We control quality of your packaging used for the primary packing of drugs or medical devices (blisters, sachets, IV bags, plastic containers, etc.).
perfusion, récipients en plastique…).
Each specific issue is covered by our adapted solutions.
Extractables / Leachables
- Analytical expertise
- 'All inclusive' service
- Bespoke / outsourced offer
- Last generation equipment
- Single contact for monitoring your project
- Risk analysis
- Toxicological report
Stability studies
- 500 m³ of climatic rooms and chambers (ICH Q2, OMS, ...).
- All types of volumes (rooms up to 50 m³).
- All types of packaging: sealed, semi-permeable...
- Photostabilities (suntest) as per ICH Q1B.
- Multiple and customizable conditions (ASTM F1980, ICH)
ICH Q3D
Albhades offers a standardized service to respond within the best time to all basic impurity issues:
- 20 years expertise in inorganic analysis and major player in the ICHQ3D process.
- Latest-generation NMR equipment
- Customized support in the choice of your strategy
Approach per finished product / component.
A standardised service for the 24 elements of ich q3d Comprising:
- Screening of 69 elements.
- Screening of 24 elements.
- Method check (LOQ, repeatability, accuracy (point 30% EJA only, 3 independent preparations) for each matrix.
- Other elements possible with specific development.
- Optimised times (15 to 20 work days).
- Analysis of 3 batches.
NITROSAMINES
- A service tailored to your needs
- A list of nitrosamines compliant with the EMA
- A self-checked service adapted to each case
NITROSAMINES
- A service tailored to your needs
- A list of nitrosamines compliant with the EMA
- A self-checked service adapted to each case
NITROSAMINES
NITROSAMINES
- A service tailored to your needs
- A list of nitrosamines compliant with the EMA
- A self-checked service adapted to each case
STRUCTURAL & MOLECULAR ANALYSES
The romainville site, dedicated to rmn analyses, is the only french laboratory to run bpf-certified rmn and cofrac approved analyses.
The benefits of NMR
- A Certipharm certified site (BPF)
- COFRAC approved analyses
- A team of experts fully dedicated to RMN analyses
- An optimised organisation and timetable
- Summary of the new candidates:
- Spectrums for summary monitoring/control.
- Control of structures.
- Purity measurement.
- Screening of applicants:
- Targets/ligands interactions.
- Base Discovery Frame.
- Pharmacy library check.
- Study of applicants structure/properties.
- Identification/quantification of unknown and impurities.
- Optimisation of processes (synthesis, purification...).
- Ab initio standards qualification.
- Development and validation of methods.
- Pharmacopeia methods:
- Raw material check.
- Release control:
- Identification.
- Limit tests.
- Dosage (DS, similar substances).
- Standards qualification.
ANTIBIOTIC TITRATION
(Ph. Eur. 2.7.2/5.3) :
- A combined offer: microbiology & chemistry
- A global expertise: validation of methods / routine analyses
- A solution tailored to your needs: Activity (LATIN SQUARE) / Dosage
The antibiotic titration comprises 2 parts:
- 1 : Technical implementation of the method: preparation, dilution, inoculation, filling of the wells and inhibition diameter measurement.
- 2 : Titration validation by a statistical analysis and an interpretation of the results obtained.
For a global offer, performance of all chemical analyses described in the monographies in order to perform a complete check of the material: biological activity & chemical dosage.