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Laboratory analysis of injectable drugs and pharmaceutical vaccines
What is an injectable drug ?
An injectable drug is a type of medication (either a gel or a liquid solution) which can be injected into the body parenterally. Injections are often intravenous, intramuscular, intradermal or subdermal.
This method of drug administration allows for exact dosages of substances to be administered without affecting the digestive system. An injected drug will also take effect faster than one taken orally.
Injectable drugs are administered using specific equipment, such as syringes, needles or glass ampoules.
Why analyze injectable drugs ?
Under strict quality requirements, vaccines and other injectable pharmaceutical products are very closely monitored all throughout their production process. The aim being to ensure that the products comply with standards.
From formulation to the filing of syringes, with filtration and sterilization steps, challenges surrounding vaccine production can vary based on the environment in which production is taking place.
The presence of impurities, a degraded or aging product, interactions between APIs and excipients… These can all cause problems and lead to a product not being put on the market or being called back.
To solve these technical problems, you are looking to cooperate with a reliable and reactive laboratory.
FILAB can assist you in monitoring the quality of your injectable drugs
FILAB offers pharmaceutical industrialists a high level of skill and a cutting-edge analytical fleet to provide services fulfilling their needs and all while complying with relevant standards.
FILAB laboratory is ISO 17025 accredited (www.cofrac.fr accreditation n°1-1793) for analyzing elemental impurities found in pharmaceutical matrices.
From analysis to R&D, FILAB laboratory is able to provide personalized support and expertise to fulfil all types of requests relating to injectable drugs :
- Particulate analysis of your injectable drugs (trouble shooting) using SEM-EDX, FTIR, LC-MS/MS…
- Chemical composition analysis of injectable solutions using GC-MS, LC-MS, ICP…
- Detection of elemental impurities in your injectable drugs (ICH Q3D) using ICP-MS or ICP-AES
- E&L testing between injectable drugs and injection equipment
- Stability testing