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Measuring Aztreonam Variations by Process Analytical Technology.

Uiyeol Yoon1,2, Ayumi Tarianto3, Philip J Almeter1,2

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Near-infrared (NIR) spectroscopy revealed significant physical and chemical inconsistencies in aztreonam for injection lyophilized product. These variations indicate multiple, independent instabilities within the manufacturing process, impacting product homogeneity and potentially clinical efficacy.

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Process Analytical Technology (PAT)

Background:

  • Aztreonam for injection is a critical antibiotic for treating Gram-negative infections.
  • Ensuring the homogeneity of lyophilized drug products is essential for consistent clinical performance.
  • Complex lyophilized matrices present challenges in maintaining uniform physical and chemical properties.

Purpose of the Study:

  • To investigate the physical and chemical homogeneity of commercially available aztreonam for injection.
  • To identify and characterize inconsistencies within and between manufacturing lots using advanced analytical techniques.
  • To assess the impact of these inconsistencies on process control and product quality.

Main Methods:

  • Near-infrared (NIR) spectrometric screening of aztreonam for injection vials.
  • High-dimensional principal component analysis (PCA) for analyzing spectral data.
  • Statistical evaluation including FSOB algorithm and quantile-quantile (QQ) plots for subpopulation validation.

Main Results:

  • Significant intra-lot variability observed, with spectral data exhibiting toroidal patterns indicative of oscillatory dynamics.
  • Extreme multidimensional outliers (up to 5.6 standard deviations) suggest multiple independent instability drivers.
  • Inter-lot analysis confirmed systemic inconsistencies, dividing the spectral library into two distinct subpopulations.
  • Specific manufacturing lots showed batch-level structural deviations, potentially linked to moisture and aliphatic fluctuations.
  • Mathematical validation confirmed the presence of distinct subpopulations, with high correlation coefficients (rtn=0.99, rts=0.88) and statistical significance (p=0.02).

Conclusions:

  • The manufacturing process for aztreonam for injection is subject to multiple, independent sources of instability.
  • Intermittent lapses in process control are suggested by asymmetric outlier distributions.
  • Product homogeneity is compromised by systemic physical and chemical inconsistencies.
  • Operations may intermittently fall outside a strict state of control, necessitating process optimization.