Our methodology is built upon regulatory adherence and the use of specialized analytical technology to solve complex, ultra-trace impurity challenges.

I. Specialized Instrumentation and Technique

We utilize specialized, state-of-the-art instrumentation as the primary platform for all high-risk impurity work:

• Mass Spectrometry (MS) Platforms: Our core methodology relies heavily on High-Resolution Mass Spectrometry (LC-HRMS) and Triple Quadrupole LC-MS/MS for achieving the necessary ultra-trace Limits of Detection (LODs) for nitrosamines and genotoxic impurities. This capability is essential for overcoming complex matrix interference issues.

• Chromatographic Separation: Comprehensive separation is achieved using advanced HPLC/UHPLC and GC/GC-MS techniques, ensuring high selectivity before MS detection.

II. Regulatory & Pharmacopeial Frameworks

All method development and testing procedures are governed by global regulatory standards:

• ICH Guidelines: Methods are developed and validated in accordance with the latest ICH Q2(R2), ICH Q14, and ICH M7 guidelines, ensuring they are stability-indicating and suitable for global submissions.

• Pharmacopeial Standards: We maintain adherence to current USP (United States Pharmacopeia) and EP (European Pharmacopoeia) standards for all relevant testing procedures.

• Data Integrity (21 CFR Part 11): Our entire analytical process operates under a 21 CFR Part 11 compliant quality system, guaranteeing the traceability, security, and integrity of all raw data and final reports.

III. Method Validation & Assurance

We specialize in advanced validation protocols designed to meet the most rigorous FDA and EMA expectations:

• LOD/LOQ Determination: Specialized protocols are employed to accurately and reliably determine Limits of Detection (LOD) and Quantification (LOQ) at the stringent Acceptable Intake (AI) levels required for nitrosamine compliance.

• Robustness and Specificity: Validation studies are specifically designed to prove the specificity and robustness of the method against known matrix components, ensuring the data will withstand regulatory scrutiny.