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The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
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Transportation of samples from the collection point to the laboratory, as well as storage and preservation techniques, are crucial for maintaining sample integrity and ensuring accurate and reliable test results.
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Storing cocaine and its metabolites in biological samples like blood and urine requires specific conditions for stability. Optimal preservation involves -20°C storage, NaF for blood, and a pH of 4 for urine to ensure accurate post-analysis custody results.

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Area of Science:

  • Forensic toxicology
  • Analytical chemistry
  • Pharmacology

Background:

  • Accurate quantification of cocaine and its metabolites in biological samples is crucial for forensic and clinical toxicology.
  • Post-analysis storage conditions can significantly impact the stability of these compounds, potentially affecting results.
  • Understanding the stability of cocaine (COC), benzoylecgonine (BE), ecgonine methyl ester (EME), and benzoylecgonine ethyl ester (EBE) is vital for reliable interpretation.

Purpose of the Study:

  • To evaluate the in vitro stability of cocaine and its primary metabolites in blood and urine over a one-year period.
  • To determine the influence of storage temperature, preservatives, and pH on the stability of these compounds during post-analysis custody.

Main Methods:

  • Stability assessment of COC, BE, EME, and EBE in blood and urine samples.
  • Evaluation of storage at -20°C and 4°C for up to one year.
  • Investigation of preservative (NaF) influence in blood and pH (ranging from 4 to 8) in urine.

Main Results:

  • At -20°C, all compounds remained stable (>80% recovery) in blood after one year.
  • Storage at 4°C led to significant degradation in blood, with NaF preservative enhancing stability.
  • Urine samples were stable except at pH 8 and 4°C, where rapid degradation occurred, with BE showing partial stability.

Conclusions:

  • Optimal storage temperature for cocaine and metabolite stability in biological samples is -20°C.
  • NaF preservative in blood and a pH of 4 in urine significantly improve long-term stability.
  • Adherence to these conditions is essential for maintaining the integrity of cocaine analytes in post-analysis custody.