Our Expertise

Isolation and Characterization of Unknown Impurities in Pharmaceuticals and Chemicals

At Chemicea, we provide comprehensive analytical solutions for the isolation, identification, and characterization of unknown impurities found in pharmaceutical products, active pharmaceutical ingredients (APIs), intermediates, fine chemicals, and specialty chemicals.

Unknown impurities can arise during synthesis, storage, manufacturing, packaging, or degradation processes. Regulatory authorities require thorough investigation and identification of impurities above specified reporting thresholds to ensure product safety, efficacy, and quality.

Our Expertise

Our team of experienced scientists utilizes advanced analytical techniques to isolate, identify, and characterize unknown impurities, degradation products, process-related impurities, and extractables/leachables.

Services Offered

• Unknown impurity isolation from APIs and formulations
• Degradation product identification
• Forced degradation studies
• Process-related impurity characterization
• Genotoxic impurity investigation
• Structural elucidation of unknown compounds
• Extractables and leachables studies
• Impurity profiling and qualification support
• Method development for impurity isolation
• Regulatory documentation support

Analytical Techniques Used

We employ a combination of sophisticated analytical instruments to accurately determine impurity structures:

Chromatographic Techniques

• HPLC (High-Performance Liquid Chromatography)
• Preparative HPLC
• UPLC
• GC (Gas Chromatography)
• LC-MS/MS
• GC-MS

Spectroscopic Techniques

• NMR Spectroscopy (⊃1;H NMR, ⊃1;⊃3;C NMR)
• FTIR Spectroscopy
• UV-Visible Spectroscopy
• HRMS (High Resolution Mass Spectrometry)

Structural Characterization

• Mass Fragmentation Analysis
• Molecular Formula Determination
• Structural Elucidation
• Comparative Spectral Analysis

Our Isolation and Characterization Process

1. Detection of Unknown Impurity

The impurity is detected through routine analysis, stability studies, process development, or quality control testing.

2. Isolation and Enrichment

The impurity is isolated using preparative chromatography techniques to obtain sufficient quantity for characterization.

3. Structural Elucidation

Advanced analytical tools such as LC-MS, HRMS, NMR, and FTIR are used to determine the molecular structure.

4. Confirmation and Reporting

The proposed structure is confirmed through comprehensive data interpretation and documented in a detailed analytical report.

Industries We Serve

• Pharmaceutical Companies
• CROs and CDMOs
• Biotechnology Companies
• Specialty Chemical Manufacturers
• Agrochemical Industries
• Research and Development Laboratories
• Academic Institutions

Why Choose Chemicea?

✔ Experienced analytical scientists

✔ Advanced instrumentation and laboratory capabilities

✔ Regulatory-compliant documentation

✔ Fast turnaround time

✔ Customized project support

✔ Confidential and secure handling of samples

✔ Cost-effective analytical solutions

Regulatory Importance

Regulatory agencies such as the U.S. Food and Drug Administration and International Council for Harmonisation require identification and qualification of impurities that exceed specified thresholds. Proper impurity characterization helps ensure product quality, patient safety, and regulatory compliance.