What Are ICH Guidelines? The ICH, a non-profit international organization founded in 1990, developed the ICH guidelines as scientific consensus documents. The ICH guidelines full form stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human…
Ozempic Impurities Explained: Ensuring Purity and Safety in Semaglutide-Based Therapies
Semaglutide has emerged as a groundbreaking therapy for managing type 2 diabetes, marketed under brand names like Ozempic. As a glucagon-like peptide-1 (GLP-1) receptor agonist, it significantly benefits glucose regulation and weight management. Its patent is set to expire…
AMSbiopharma, Sponsor of the XIX Iberian Peptides Meeting (EPI 2025)
We are pleased to announce that AMSbiopharma will be an official sponsor of the XIX Iberian Peptides Meeting (EPI 2025), which will take place from February 26 to 28, 2025. This biennial event is a key meeting point for Portuguese…
Peptide Drugs: Discovery and Development Explained
What Are Peptide Drugs and How Are They Used in Therapeutics? Peptide drugs, also known as therapeutic peptides, are short chains of amino acids, typically consisting of molecular weights of 500-5000 Da. These molecules are designed to mimic natural peptides…
Application of Hydrophilic Interaction Chromatography (HILIC) in pharmaceutical analysis
Analyzing polar compounds via high-performance liquid chromatography (HPLC) has long posed a challenge due to their limited retention on reverse-phase stationary phases, the most widely used in laboratories. To increase the retention of these compounds in reverse phase, ion-pairing chromatography…
How to Manage Nitrosamine Contamination in Active Pharmaceutical Ingredients
In 2018, the detection of nitrosamines in sartan-type drugs, medications to treat high blood pressure and heart failure, set off all the alarm bells. The presence of N-nitrosodimethylamine (NDMA) in Valsartan was the first indication. Later appearances of other nitrosamines…
AMSbiopharma launches an Innovation Plan to strengthen its position in the biopharmaceutical analytical services sector
AMSbiopharma, a CRO (Contract Research Organization) belonging to AMSlab Group and specialized in advanced analytical services for the chemical, pharmaceutical, and biopharmaceutical industries, announces the launch of its new Innovation Plan. The objective is to position the company as a…
New update for the ICH Q2 (R2) guidance on Analytical Process Validation
As planned for months, the draft ICH Q14 Guideline for AQbD Method Development and the draft ICH Q2 (R2) Guideline for Analytical Process Validation were published at the end of 2023. Both were developed over the past year and come…
AMSbiopharma and LEF announce strategic partnership to expand service offering
AMSbiopharma is pleased to announce a new strategic partnership with LEF, a CRO and CDMO based in Portugal and part of the National Association of Pharmacies (ANF) Group. This partnership will allow both companies to complement each other’s strengths and expand the…
AMSbiopharma introduces an important advance for the analysis of nitrosamines in different active pharmaceutical ingredients of vitamin B12
AMSbiopharma, our specialized line of analytical solutions for the quality control of pharmaceutical products, announces the launch of a service for the analysis of nitrosamines in vitamin B12. This service, developed with state-of-the-art technology, makes a difference in the analytical services for…