amsbiowp, Author at AMSbiopharma

ICH Q3E Guideline: Impurities Assessment and Control

The safety and efficacy of pharmaceutical products largely depend on controlling impurities in their formulations. Therefore, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed various guidelines, with the upcoming ICH Q3E guideline…

the ICH guidelines for drug stability testing explained

ICH Guidelines: Drug Stability Testing Essentials

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…

Advanced Analytical Methods in Detecting Impurities in OZEMPIC

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…

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…

ICH Q3E Guideline: Impurities Assessment and Control

ICH Guidelines: Drug Stability Testing Essentials

Ozempic Impurities Explained: Ensuring Purity and Safety in Semaglutide-Based Therapies

Peptide Drugs: Discovery and Development Explained

Application of Hydrophilic Interaction Chromatography (HILIC) in pharmaceutical analysis

How to Manage Nitrosamine Contamination in Active Pharmaceutical Ingredients

AMSbiopharma launches an Innovation Plan to strengthen its position in the biopharmaceutical analytical services sector

New update for the ICH Q2 (R2) guidance on Analytical Process Validation

AMSbiopharma and LEF announce strategic partnership to expand service offering

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