BIOLOGYCHEMISTRY

ANALYTICAL EXPERTISE AND QUALITY CONTROL FOR THE PHARMACEUTICAL INDUSTRY

Albhades, a multidisciplinary expertise for an optimized and personalized management of your projects.

A mature quality system regularly audited and inspected: customer audits, ISO 13485 and ISO 9001 certifications, pharmaceutical GMP, accreditations ISO 17025 by COFRAC*, FDA registration. On request, studies performed under GLP quality system.

Why Albhades?

The diversity of our technical platforms allows us to meet most of the requirements of analytical development and quality control. Our teams ensure an efficient and personalized follow-up of your requests, from the feasibilty to the delivery of the service. Our project managers are attentive to your needs: development, validation and transfer of methods, stability studies, new services...

*certificates and scope available on www.albhades.com

FROM DEVELOPMENT TO QUALITY CONTROL

ANALYTICAL EXPERTISE AND QUALITY CONTROL FOR THE PHARMACEUTICAL INDUSTRY

CHEMISTRY

ELEMENTAL IMPURITIES - STRUCTURAL ANALYSES - STERILITY - STABILITY CONTENT-CONTAINING INTERACTION - ICHQ3D - CHALLENGE TEST - ANALYTICAL DEVELOPMENT - METHOD VALIDATION - MICROBIOLOGY - ANALYTICAL CHEMISTRY EXTRACTABLES/LEACHABLES

ACCREDITED ACCRÉDITATIONN° 1-1322PORTÉE

DISPONIBLE SURWWW.COFRAC.FR

ESSAIS

DevelopmentDevelopment and validation of analytical methods

Process validation

ICH Q3D

Forced degradations

Extractables / Leachables

Content-containing interaction

Stability studies

Quality control

Finished products

Packaging items

Qualification of process water

Raw materials

FROM DEVELOPMENT TO QUALITY CONTROL

Raw materials according to pharmacopoeias. All finished products according to the methods described in your regulatory file.Process water (analyses upon receipt).

*certificates and scope available on www.albhades.com

• 20 years of experience in chemistry and biology.

• A complete technical offer in accordance with your needs.

• Services accredited ISO 17025 by COFRAC*.

FOCUS NEWSLaser particle size

according to Ph. Eur. 2.9.31 /

USP <429>

Packaging A complete content-containing interaction study involves evaluating the stability of the product in its packaging:• Stability: adsorption, absorption:• Integrity of the packaging: tightness, sterility, evaporation, test in use...• Release of certain compounds constituting the packaging: labels, inks...• Forced degradations.

For each of these problems, we offer you adapted solutions.

• Expertise and personalized service.• A single site for storage and testing.• Large stocking capacity and diverse climatic

conditions.

Extractables / Leachables

• An «all inclusive» offer of tailor-made prices including personalized support from the study design to the writing of the report.

Stability studies

• 400 m3 of rooms and climatic chambers (ICH Q2, WHO,...).

• All types of volumes (up to 30 m3).• All types of packaging: waterproof,

semi-permeable...• Photostabilities according to ICH Q1B.

FOCUS NEWSCompliant with Ph. Eur. and USP requirementsForced contamination

Use tests

Albhades offers you a standardised service to respond as quickly as possible to your problems concerning elementary impurities

ICH Q3D

Finished product / Component approach :

A standardized service for researching the 24 elements of the ICH Q3D including: • Screening of 69 elements.• Screening of the 24 elements.• Verification of the method (LOQ, repeatability,

accuracy (point 30% PDE only, 3 independent preparations) for each matrix.

• Other possible elements with specific development.

• Optimized lead times (15 to 20 days).• Analysis of 3 batches.

• 20 years of expertise in inorganic analyses. • A major player in the ICH Q3D approach.• Latest generation equipment.• Personalized advice in the choice of your strategy.

FOCUS NEWS Manufacturer of

veterinary pharmaceutical products: be ready for

new guideline on elemental impurities

EMA/CVMP/QWP/631010/2017 applicable from 2020-2022 depending on the product.

Rely on our ICH Q3D solutions

• A turnkey offer.• GMP environment.• A team of experts to support you.

Structural & molecular analysesCharacterization of your productsImpurity identification Absolute purity measurementDetermination of concentrations

NMR HRMSUHPLC-HRMS

Our equipment:GC-MSLC-MS

An absolute method for the qualification of primary standards / references (identification, title): no need to use other primary standards !

• Synthesis of new candidates Spectra for monitoring

/ control of syntheses Structural inspection Purity measurement• Screening of candidates Target / ligand interaction Fragment Base Discovery• Pharmacological control• Structural study / candidate

properties

• Identification / quantification of unknowns and impurities

• Process optimization (synthesis, purification...)

• Qualification ab initio of standards

• Method development and validation

• Pharmacopoeia methods Raw material control• Quality control Identification Limit tests Assays (drug substance,

related substances ...)

Search Development Quality control

FOCUS NEWS Advantages of NMR: Universal technology

QuantitativeNon-destructive

Robust

At Albhades, take advantage to perform structural analyses conform with the GMP requirements

• Qualification of standards

940 avenue de Traversetolo 04700 Oraison - FranceTél. : + 33 (0) 492 794 141 Fax : + 33 (0) 492 794 142albhades@albhades.com www.albhades.com

For any request for a quote: info@albhades.com For any request for information: + 33 (0) 492 794 148

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Our job: to support you in your projects.Our teams are experts, available and attentive to your requests.Our customers appreciate our technical skills, our reactivity, our multidisciplinary approach and the maturity of our quality system.