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GBA Pharma Labs Trace-level analytic for N-nitrosamines

Trace-level analytic for N-nitrosamines

Testing for N-nitrosamines is a hot topic in the pharmaceutical industry since 2018 when these potential carcinogens were found first in sartans and later on in ranitidine and some slow-release metformins. Manufacturing requirements have now become more stringent and demands on chromatography and mass spectrometry methods that meet regulatory requirements are increasing. Detection and quantification of these trace nitrosamines in APIs and drug products can be challenging and necessitates the use of advanced and sensitive tools to meet regulatory requirements.

GBA Pharma Labs offers highly sensitive Orbitrap-based mass spectrometry capable of selectively determining analytes at low concentrations with high confidence. Data acquisition and processing are carried out with a cGMP qualified Chromeleon CDS software with audit trails to assure data integrity and protection.

Our approaches meet and exceed FDA’s established regulatory requirements to help pharmaceutical customers to identify and quantify trace (ppb) nitrosamine in customized systems optimized for the respective sample matrix.

Besides a targeted screening of nine common nitrosamines (Figure 1), GBA Pharma Labs offers full scan measurement of samples including MS/MS experiments in APCI+ mode allowing non-targeted screening followed by data processing using Compound Discoverer software and database queries to cover for other nitrosamines present in the samples.

Compared to other currently available methods, the non-targeted screening approach offers a higher safety level and is another unique selling point of the Orbitrap-based method. GBA Pharma Labs will be pleased to provide you with further advantages and details of the method in a personal talk.

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs - GMP Testing

GBA Pharma Labs – GMP Testing

GBA Pharma Labs - GMP Quality Control

GMP Quality Control

GBA Pharma Labs - Method Development & Validation

Method Development & Validation

GBA Pharma Labs - Stability Studies

Stability Studies

GBA Pharma Labs - Dissolution


GBA Pharma Labs - Extractables & Leachables

Extractables & Leachables

GBA Pharma Labs - Packaging Material Testing

Packaging Material Testing

GBA Pharma Labs - Particle Determination

Particle Determination

GBA Pharma Labs - Elemental Impurities Testing

Elemental Impurities Testing

GBA Pharma Labs - Microbiology


GBA Pharma Labs - Regulatory Services

Regulatory Services

GBA Pharma Labs - Amino Acid Analysis

Amino Acid Analysis

GBA Pharma Labs - Instrumentation


GBA Pharma Labs - N-nitrosamines


GBA Pharma Labs - qPCR


GBA Pharma Labs - iCEF


GBA Pharma Labs - Protein characterization

Protein Characterization

GBA Pharma Labs - Limit test for DEG and EG by GC

Limit test for DEG and EG by GC

GMP Testing

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