background

Unknown Impurity Isolation And Characterization

Unknown impurities can significantly impact product quality, safety, and regulatory compliance. Cleanchem Lab offers comprehensive impurity isolation and characterization services designed to identify trace-level unknown compounds in pharmaceutical and chemical products.

Unknown Impurity Isolation And Characterization

Our laboratory is equipped with advanced analytical instrumentation and experienced scientists capable of handling complex impurity profiling projects. We isolate impurities from APIs, intermediates, raw materials, finished products, and degradation samples using sophisticated preparative techniques and analytical methodologies.

Our Capabilities Include:

  • Unknown impurity isolation from APIs and formulations
  • Degradation impurity isolation
  • Process-related impurity identification
  • Forced degradation studies
  • LC-MS/MS and GC-MS analysis
  • NMR characterization (1H, 13C, DEPT, 2D-NMR)
  • Preparative HPLC purification
  • Structural elucidation and impurity profiling
  • Support for DMF, ANDA, and regulatory submissions

gallery img
gallery img
gallery img
gallery img
gallery img
Services Related Tips & Info

We are inviting quotations for specialized scientific services involving compound characterization, material refinement, and tailored chemical development. The scope of work may include detailed analysis, quality assessment, enhancement of material purity, and synthesis of target compounds as per project requirements. Service providers should be equipped with modern instrumentation and technical capabilities to ensure high accuracy, regulatory compliance, and efficient turnaround. We expect comprehensive documentation, including data reports, certificates, and analytical results, along with adherence to confidentiality and data protection protocols. Please include estimated timelines, pricing details, input material requirements, and any applicable terms and conditions in your quotation.

Which analytical techniques are available in-house?

We offer HPLC, GC, UV, FTIR, LC-MS/MS, ICP-MS, and NMR (1H, 13C), among others.

Do you follow regulatory guidelines such as ICH or USP?

Yes, we comply with ICH Q2(R1) for method validation and follow USP/EP monographs for testing.

Can you perform method development and validation?

Absolutely. We offer full method development, optimization, and validation services as per regulatory standards.

What will be included in the final analytical report?

Our reports include chromatograms, raw data, integration details, method summary, and a signed Certificate of Analysis (COA).

Do you conduct stability studies under ICH conditions?

Yes, we offer long-term and accelerated stability studies under ICH conditions with time-point analysis.

Overview

We offer a comprehensive range of specialized scientific services tailored to meet the dynamic needs of the pharmaceutical, chemical, and biotechnology industries. Our analytical services encompass method development, validation, impurity profiling, and stability studies using advanced instrumentation like HPLC, GC, NMR, and LC-MS in compliance with international regulatory standards. Our purification capabilities ensure high-purity isolation of raw materials, intermediates, and final compounds through techniques such as preparative HPLC, flash chromatography, and crystallization. Additionally, we provide custom synthesis solutions ranging from milligram to kilogram scale, covering route development, process optimization, and complete structural characterization. Each service is delivered with a focus on accuracy, efficiency, confidentiality, and regulatory compliance to support your research, development, and manufacturing goals.

Document