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Lactose Monohydrate Low Endotoxin

Premium sieved lactose monohydrate with low endotoxin content for inhalation and parenteral applications.

MEGGLE’s Lactose Monohydrate Low Endotoxin (LE) is a high-purity excipient designed for parenteral and inhalation applications, where low endotoxin levels are essential for patient safety. By meeting stringent regulatory standards such as Ph. Eur., USP-NF, JP, and ChP, it ensures global acceptance and simplifies pharmaceutical formulation development. Additionally, its inclusion in the FDA Inactive Ingredient Database confirms its suitability for use in critical drug formulations, supporting compliance with industry requirements.

Lactose Monohydrate Low Endotoxin plays a crucial role as a bulking agent and stabilizer, particularly in freeze-drying (lyophilization) and spray-drying processes, where its cryoprotective properties help preserve the structural integrity and functionality of temperature-sensitive APIs. Its low bioburden and endotoxin content reduce the risk of adverse immune reactions, making it particularly beneficial for injectable formulations and dry powder inhalers (DPIs). With its high consistency, stability, and safety profile, Lactose LE is a versatile and reliable excipient that enhances pharmaceutical manufacturing efficiency and product quality.

Benefits

  • High purity grade
  • Low bioburden, low endotoxin
  • Q3D statement for parenteral and inhalation applications
  • Conforms to Ph. Eur., USP-NF, JP and ChP
  • Listed in FDA inactive ingredient database for inhalation and parenteral applications
  • Usage for stabilization and protection in temperaturesensitive production processes

Areas of Application

  • DPI formulations
  • Parenteral/Injectables
  • (Thin-film) freeze-drying and spray-drying (high dose formulations and sensitive APIs)

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