Isolation, Purification and Characterisation of Unknown Impurities

We specialize in analytical services focused on the isolation, purification, and characterization of unknown impurities in various pharmaceutical compounds. Our services cover:

  • NCEs
  • APIs and formulation of DS and DP
  • Small peptides
  • Nucleosides
  • Nucleosides
  • More

Isolation of Unknown Impurity

Regulatory agencies prioritize controlling impurities, specifically potential genotoxic impurities (PGIs), during drug development approval to ensure the safety of pharmaceutical products. Guidelines set by ICH govern reporting, identification, and qualification thresholds of impurities to safeguard human health when administering drugs.

Impurities in drug substances can originate from different stages of the synthetic process, from starting materials to the degradation process during storage. ICH guidelines mandate the characterization of any unknown impurity exceeding 0.1% in new drug substances, while those below this threshold generally do not require identification unless the potential risk is significant.

It is essential to address impurities early in the API scale-up process to avoid delays in drug development and ensure patients’ safe administration of pharmaceutical products. Adhering to ICH guidelines is crucial in controlling impurities and maintaining the quality and safety of drugs throughout the manufacturing process.

To isolate and identify an unknown impurity, a series of analytical techniques are typically employed. These include:

  1. Chromatographic separation: High-performance liquid chromatography (HPLC) or gas chromatography (GC) can be used to separate the drug substance from its impurities based on its different physicochemical properties.
  2. Mass spectrometry: Mass spectrometry is used to detect and characterize impurities based on their molecular weight and fragmentation patterns. Techniques such as liquid chromatography-mass spectrometry (LC-MS) or gas chromatography-mass spectrometry (GC-MS) are commonly utilized.
  3. Nuclear magnetic resonance spectroscopy (NMR): NMR spectroscopy provides information about the chemical structure of molecules, including impurities. It can be used to determine the connectivity of atoms in a compound, as well as identify functional groups and confirm the presence of specific structural motifs.
  4. Infrared spectroscopy (IR): IR spectroscopy is useful for identifying functional groups present in compounds by measuring their absorption of infrared radiation.

By employing these techniques, scientists can isolate and characterize unknown impurities present in pharmaceutical drug substances with high precision and accuracy. This ensures that any potential risks associated with these impurities are identified and controlled during drug development processes for improved patient safety.

Veeprho’s Expertise

The Veeprho lab is equipped with cutting-edge technology for high-end purification processes, including LCMS and preparative HPLC in both normal and reverse phases. 

Our equipment allows us to achieve the necessary analyses for the determination of the structure of an impurity or of your compound

  • NMR analyses (1H, 13C, DEPT, COSY, HMBC, HSQC…)
  • HRMS
  • IR
  • LCMS

Therefore, we can deliver a Certificate of Analysis (CoA) corresponding to your needs.

Our experienced scientists handle Mass Directed Purification (MDP) and Supercritical Fluid Chromatography (SPC) for achiral and chiral compounds, providing thorough analytical support from start to finish.

Our Methodology

Our methodology combines advanced chromatographic techniques with skilled analytical expertise to ensure precise isolation and purification of impurities. 

We employ Mass Directed Purification (MDP) to target and segregate specific masses from complex mixtures, optimizing purity levels. Our Supercritical Fluid Chromatography (SFC) enables the efficient separation of enantiomers, crucial for chiral compounds’ analysis.

This meticulous approach ensures that even the subtlest impurities are identified and extracted, upholding the integrity of pharmaceutical development.

End-to-End Analytical Support

At the core of our service is a commitment to comprehensive customer support. Our state-of-the-art analytical lab center is a testament to this, featuring the latest in analytical instrumentation. From initial isolation to the final purification and detailed characterization, our end-to-end support spans the entire spectrum of analytical services.

By providing a Certificate of Analysis (CoA) tailored to your specific needs, we affirm our dedication to delivering high-quality, cost-effective solutions that propel pharmaceutical advancements forward.

The Challenge

Isolating the peak of interest from complex matrices like degraded samples or crude mixtures is a formidable challenge, but one that our team meets with advanced method development and a deep understanding of column chemistry.

We have successfully isolated impurities at concentrations of less than 1.0% and have optimized degradation procedures to ensure the utmost purity and efficacy of the pharmaceuticals.

The Benefits to Pharmaceutical Manufacturers

Pharmaceutical impurities are the unwanted chemicals that remain with APIs or develop during formulation, or upon degradation of both API and formulated APIs to medicines.

Our services are essential to mitigate the presence of these unwanted chemicals that, even in small amounts, influence the efficacy and safety of pharmaceutical products.
Impurity Reference Standards are essential for maintaining the reliability and security of pharmaceutical products. Identification, measurement, and control of contaminants in drug substances and drug products depend on these reference materials.

Why Impurity Isolation Services are Required

Impurity isolation is not merely a procedural necessity; it is crucial and required in drug safety and efficacy.

  1. Patient safety: Establishing impurity limits to ensure drug safety and effectiveness.
  2. Regulatory compliance: Adhering to health authority regulations for market approval.
  3. Quality control: Referencing impurity levels to maintain product purity during production.
  4. Stability and shelf life: Assessing impurity effects to ensure drug stability over time.

Process optimization: Using impurity data to refine manufacturing and enhance product quality.

Our Commitment

At Veeprho, we understand the profound impact that precise impurity standards have on the entire pharmaceutical landscape. Our dedication to providing comprehensive and reliable impurity standards has empowered researchers and manufacturers to achieve excellence.

We are committed to delivering services that not only meet the rigorous demands of industry regulations but also support the advancement of medical science for the betterment of patient outcomes.

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