Endotoxin detection can be challenging when pharmaceutical formulations interfere with conventional test methods or affect endotoxin recovery.
Microcoat combines established assay formats with scientific expertise to develop suitable testing strategies for your product. From routine sample analysis to method validation and low endotoxin recovery studies, our team supports your specific testing requirements.
Reliable endotoxin determination using established assay formats, with testing approaches selected according to sample characteristics and analytical requirements.
Investigate endotoxin masking in pharmaceutical formulations through product-specific hold-time studies and evaluation of recovery over time.
Establish suitable endotoxin testing methods through interference testing, comparative studies and product-specific method validation.
Support the identification and validation of endotoxin removal approaches in small-scale models and investigate challenging testing results.
Kinetic chromogenic and turbidimetric assays for sensitive endotoxin detection in suitable sample matrices.
Fluorescence-based assays using recombinant Factor C instead of horseshoe crab lysate — a sustainable, animal-free alternative for endotoxin-specific detection.
ELISA-based endotoxin detection: endotoxin is captured on a solid phase, interfering matrix components are washed away, and detection follows with recombinant Factor C.
Low Endotoxin Recovery (LER) occurs when endotoxin becomes increasingly difficult to detect in certain pharmaceutical formulations over time.
Endotoxin masking may occur in formulations containing certain surfactants and chelating agents, reducing measurable endotoxin recovery over time.
Microcoat supports product-specific hold-time studies to investigate endotoxin masking and assess recovery under defined storage conditions. Demasking feasibility studies can help explore alternative approaches for challenging formulations.
Product-specific hold-time studies
Evaluation of endotoxin masking over time
Demasking feasibility studies
Scientific support for interpreting results
When standard endotoxin testing approaches reach their limits, Microcoat provides scientific support to investigate interference, evaluate alternative methods and develop product-specific testing strategies.
Investigate the Challenge
Identify potential causes of test interference, unexpected results or low endotoxin recovery.
Evaluate Alternatives
Compare suitable testing approaches and explore potential solutions for challenging formulations.
Establish a Suitable Strategy
Support method adaptation, validation and the interpretation of study results.
Tell us about your product, sample matrix and testing challenge. Our team will review your requirements and discuss suitable next steps.
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Share a few details about your testing requirements. Our team will get in touch to discuss your project.
Microcoat's Pyrogen Testing Services support the detection of pyrogenic substances beyond bacterial endotoxins, including testing approaches based on the Monocyte Activation Test (MAT).
From assay development to commercial manufacturing — we support your project at every stage.
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