Analysis of related substances of pharmaceutical products
Your needs: analyze the related substances present in your pharmaceutical products
To begin with, related substances are organic impurities. They can be derived from intermediates also called by-products of synthesis or degradation products. Once identified, these substances have an acceptance threshold when they are present in a pharmaceutical product.
Indeed, related substances are the subject of monographs in the pharmacopoeia. Regulations have been defined that describe the requirements they must meet to guarantee the quality of the medicine.
Are you looking for a reliable and responsive analytical laboratory with know-how and analytical expertise? Call on FILAB!
Our solutions: supporting pharmaceutical manufacturers in the research and quantification of related substances in pharmaceutical products
FILAB offers pharmaceutical companies technical expertise and state-of-the-art analytical equipment. Indeed, FILAB offers you tailor-made expertise services for the research and quantification of related substances in your drug or active ingredient (API):
Our services
Analytical development in laboratory by GC-MS or LC-MS
Analysis of the final chemical composition of the product according to the environmental conditions (temperature, humidity, exposure to light...) by GC-MS, HPLC or FTIR
Study of container-content interactions
Analysis of active ingredients
Analytical laboratory validation according to the ICH Q2 guideline
Stability study according to ICH Q1A
Analysis and identification of impurities (molecular characterizations,...)
Laboratory support and advice
In order to have a substance analysed as a pharmaceutical related substance, it is recommended to use a laboratory specialised in pharmaceutical testing and analysis.
It is important to note that the analysis process may vary depending on the substance to be analysed and the specific needs of each client. It is therefore recommended that you contact us directly to discuss your requirements and obtain detailed information on the analytical process.
Are you wondering "how to analyse a substance"?
FILAB is your accredited analytical laboratory experienced in the analysis of pharmaceutical products. Here are some reasons why you might consider using FILAB to analyse a pharmaceutical-related substance:
Expertise: FILAB has a team of qualified experts in pharmaceutical analysis who can provide solutions tailored to your specific needs.
Accreditation: FILAB is accredited by COFRAC, the French Accreditation Committee, which guarantees the quality and reliability of its analysis.
State-of-the-art technology: FILAB uses state-of-the-art technologies to perform accurate and reliable analysis on substances, including related substances of pharmaceutical products.
Speed: FILAB strives to provide fast results, usually within 5-10 working days.
Confidentiality: FILAB is committed to protecting the confidentiality and intellectual property of its clients by offering confidential analytical services.
In short, if you are looking for a highly qualified and reliable analytical laboratory to analyse a pharmaceutical related substance, FILAB is the option of choice for you. Contact us to discuss your project.
The following are the recommended steps for having a drug-related substance analysed:
Find a specialised analytical laboratory. FILAB is the laboratory par excellence that can meet your substance analysis needs.
Contact us for a quote
Prepare a sample of the substance: take a representative sample of the substance you wish to have analysed.
Send the sample to the analysis laboratory: contact us to find out more about our sample sending process and send the sample of the substance to be analysed.
Wait for results: the laboratory will test and analyse the sample and provide a detailed report of results.
