The Nitrosamine puzzle: What We Learned in the Last Five Years

The Nitrosamine (NA) issue, often termed the "Saga," has been a focal point of attention for both the pharmaceutical sector and regulatory entities over the past half-decade...

Impurity Profiling

Impurity profiling plays a crucial role in pharmaceutical product development and quality control. It involves the identification, quantification, and characterization of impurities present in drug substances and drug products...

Key Differences Between Internal Reference Standards, Working Standards, and Reference Standards

In the pharmaceutical field, there are several types of standards used to ensure accuracy, consistency, and reliability in drug development, manufacturing, and quality control processes...

Custom Synthesis of Impurity Standard Material

Impurity standard materials are critical tools in pharmaceutical analysis, enabling the accurate identification, quantification, and control of impurities in drug substances and drug products...

Challenges in HPLC Method Development for Impurity Identification

High-Performance Liquid Chromatography (HPLC) is a widely used analytical technique for impurity identification and quantification in the pharmaceutical industry...

The Complexities of Pharmaceutical Impurity Characterization: Challenges and Solutions

Pharmaceutical impurity characterization is a critical aspect of ensuring the safety, efficacy, and quality of pharmaceutical products...

Working Standards vs. Reference Standards: Understanding the Key Differences

Pharmaceutical manufacturing is a complex process that requires a high level of precision and accuracy. Working standards and reference standards are two important terms that are used in this field...

Helpful Details While Sending an Enquiry of Impurity Standards – SynThink

Pharmaceutical impurity standards play a crucial role in ensuring the safety and efficacy of drugs. They are used as reference materials for the identification, quantification, and control of impurities in pharmaceutical products...

Genotoxic Impurities

Genotoxic impurities are substances that can cause damage to genetic material, including DNA, which can lead to mutations or cancer...

Non-Pharmacopeial Reference Standards

In the pharmaceutical industry, accurate testing and quality assurance are critical for ensuring the safety and efficacy of medicines...

Controlling Nitrosamine Impurities

The nitrosamines may occur in very small quantities in some drugs but they are a potential carcinogen...

Most Important Factors For Pharmaceutical Impurities / Reference Standards

It is interesting to discuss the most important factors for the Pharmaceutical impurities / Reference standards in detail...

Category: Impurities/Reference Standards

The Nitrosamine puzzle: What We Learned in the Last Five Years

Impurity Profiling

Key Differences Between Internal Reference Standards, Working Standards, and Reference Standards

Custom Synthesis of Impurity Standard Material

Challenges in HPLC Method Development for Impurity Identification

The Complexities of Pharmaceutical Impurity Characterization: Challenges and Solutions

Working Standards vs. Reference Standards: Understanding the Key Differences

Helpful Details While Sending an Enquiry of Impurity Standards – SynThink

Genotoxic Impurities

Non-Pharmacopeial Reference Standards

Controlling Nitrosamine Impurities

Most Important Factors For Pharmaceutical Impurities / Reference Standards

SynThink Research Chemicals

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