What is an injectable product?
An injectable product is a drug (gel or solution) that can be injected into the body by parenteral route. Injections are most frequently intravenous, intramuscular, intradermal or subcutaneous.
This type of administration allows for an exact dosage of a product, without undergoing any digestive changes. The action of an injected drug is also faster than by oral route.
Injectable drugs are administered with specific equipment such as syringes, needles, ampoules or glass vials.
Why analyze your injectable products?
Faced with stringent quality requirements, vaccines and other pharmaceutical injectables are subject to particular attention throughout the production process, with the aim of guaranteeing product conformity.
From formulation to filling, through filtration and sterilization, the quality issues involved in the production of vaccines and injectables differ depending on the manufacturing environment.
The presence of impurities, degradation during product ageing, active ingredient-excipient interaction, etc. can constitute problems that can lead to the withdrawal of the injectable solution or to its not being approved for marketing.
To meet these technical challenges, you are looking for a reliable and reactive laboratory.
FILAB supports you in the quality monitoring and expertise of your injectable products
FILAB provides pharmaceutical companies with high-level human skills and state-of-the-art analytical equipment in order to offer them services that meet their compliance criteria.
FILAB is accredited ISO 17025 by COFRAC (www.cofrac.fr: accreditation number 1-1793) for the analysis of elemental impurities in pharmaceutical matrices.
From analysis to R&D, the FILAB laboratory offers tailor-made expertise for several types of requests related to the analysis of injectable products
- Analysis of particles in your injectable formulation (troubleshooting) by SEM-EDX, FTIR, LC-MSMS…
- Analysis of the chemical composition of injectable solutions by GC-MS, LC-MS, ICP…
- Search for elemental impurities in your injectable product (ICHQ3D context) by ICP-MS or ICP-AES
- Study of extractables and leachables between injectable products and injection materials.
- Stability study
