Stability Testing

Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.

Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l...

XEDEV provides a broad range of analytical tools including : • Solid state analysis: mDSC, XRPD, PLM, TGA, FTIR, RAMAN • Powder characterisation : SEM, PSD (both wet and dry), flowability • Tablet characterisation : friability, disintegration, hardness, dissolution • Residual solvent determination :...

Creating pharmaceutical reference standards to customer specification has always been at the heart of the Mikromol business. We understand that you are constantly discovering new actives and impurities of interest - each year, our dedicated, highly-qualified customs team produces several hundred new materi...

Grünenthal GmbH offers a selected range of products which includes Tramadol HCl, as API, bulk and/ or finished dosage form. Please contact us for more information.

Method Development and validation
Stability Studies
European testing & batch certification

QACS Lab is GMP/GLP certified and provides contract laboratory testing for Pharmaceuticals. Methodologies stay in accordance with EMA & FDA. QACS is equipped with Microbiological - Chemical - Molecular - Packaging laboratory premises to provide variety of Pharmaceutical testing solutions &...

Analytical Services: QC Chem/Microbio, stability, etc.

Conscio offers GMP-certified and ICH-compliant chemistry, manufacturing and controls assays (CMC) as well as analytical support during validation of manufacturing processes. Samples are analyzed by approved and validated methods for routine batch testing, stability studies, analyses of high potency product...

We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...

• Genexol®PM Inj.(Paclitaxel)   • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...

Solvias offers the complete range of stability studies according to ICH guidelines for drug development and follow-up stability studies, covering all ICH standard storage conditions as well as low temperature storage. All our processes take place on one connected site, where there is a high degree of QC ex...

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing

GALENIC DEVELOPMENT
• Preformulation studies.
• Design and galenic develop...

Imagine design and prototyping Services that enable accelerated market introduction with increased accuracy in stability testing using the most cost-effective blister film to meet your requirements. Contact us for more information.

MedPharm leverages its 20 years of experience to help develop and validate IVRT methods for its clients. We successfully perform IVRT based on FDA and EMA guidelines and continue to influence how these methods are utilized in regulatory submissions.

IVRT is the established method recogniz...

Our expert team provides full analytical, microbiology and stability services to ensure that your raw materials, bulk product and finished products are qualified, analyzed and released to cGMP standards.

Our services include:

Analytical
• Raw material and drug product...

Neotron Pharma provides Stability tests according to ICH standards (zones I, II, IV). We can carry out stability studies in their entirety (storage + analysis) or provide only storage service. The conditions we can offer are listed below:

- 40°C ± 2°C , 75% ± 5% U.R. 
- 30°C ± 2°C&n...

Study Types-In-use studies (broaching, reconstituted product stability, multi-use container stability)
-Formulation development studies including stress studies
-Photostability (Options I and II)
-Comparator studies
-Thermal cycling/freeze thaw
-Shipping excursion studies
-Long-term stabi...

From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 2...