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      • Calcium Carbonate
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      • Silica
    • Organic Chemicals
      • Actual Sugars
      • Artificial Sweeteners
      • Carbohydrates
      • Cellulose
      • Cellulose Esters
      • Cellulose Ethers
      • CMC and Croscarmellose Sodium
      • Converted Starch
      • Dried Starch
      • Microcrystalline Cellulose
      • Modified Starch
      • Starch
      • Sugars
      • Sugar Alcohols
    • Petrochemicals
      • Acrylic Polymers
      • Glycols
      • Mineral Hydrocarbons
      • Mineral Oils
      • Mineral Waxes
      • Petrolatum
      • Polyethylene Glycol (PEG)
      • Povidones
      • Propylene Glycol
      • Other Petrochemical Excipients
    • Oleochemicals
      • Fatty Alcohols
      • Glycerin
      • Mineral Stearates
      • Pharmaceutical Oils
      • Other Oleochemical Excipients
    • Proteins
  • Applications
    • 3D Printing – Drug Carrier
      • 3D Printing
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      • Coating
      • Colour / Color
      • Coating Systems and Additives
      • Controlled Release Excipient
      • DC excipient
      • Disintegrant / Superdisintergrant
      • Drug Carrier
    • Emulsifier – Glidant
      • Emulsifier
      • Excipient for Inhalation
      • Filler
      • Film former
      • Flavour / Flavor
      • Glidant
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      • Orally Dissolving Technology Excipient
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      • Plasticizer
      • Preservative
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      • Solubilizer
      • Speciality Excipient
      • Surfactants
      • Suspension Agent
      • Sustained Release Agent
      • Sweeteners
      • Taste Masking
      • Topical Excipient
      • Viscosity Agent
  • Sources
    • Handbook of Pharmaceutical Excipients – 9th Edition
    • EINECS Numbers
    • Excipient DMF List
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    Sigachi
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      • Fuji Chemical Industries
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      • Gangwal Healthcare
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      • Dr. Paul Lohmann
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Startseite » News » Quantification of Trace Levels of Active Oxygen in Pharmaceutical Excipients

Quantification of Trace Levels of Active Oxygen in Pharmaceutical Excipients

16. March 2018

16. March 2018

Pharmaceutical drug products contain various excipients in combination with the active pharmaceutical ingredient (API), and those excipients have the potential to have as impurities reactive oxygen species that can react directly with the API and lead to oxidative degradation. Such degradation can impact long-term stability of the drug product, reduce drug product purity, limit shelf life, and increase time to market. Peroxy compounds are a common class of such reactive impurities, but there is an absence in the literature of a method for detection of total peroxide level in pharmaceutical excipients when the identity of the peroxy contaminant is not known. In this thesis, novel modifications were made to the 1966 ASTM E 299-08 method for enhanced and robust detection of active oxygen in pharmaceutical excipients. The modified ASTM E 299-08 method was evaluated using spiked solutions of hydrogen peroxide, a hydroperoxide compound, and a peroxide compound. Liquid and solid excipients were then evaluated for active oxygen levels to demonstrate the utility and breadth of the modified method to cover a wide range of excipients. The polyethylene glycol (PEG) class of compounds was chosen for more in-depth evaluation due to their susceptibility to autoxidation and the existence of various molecular weight grades of PEG compounds. PEG 1000 was chosen along with lestaurtinib (CEP-701) to prepare a novel drug product, which was evaluated on stability for active oxygen and assay impurity levels. The results showed that the modified ASTM E 299-08 method successfully quantified both the total active oxygen levels and the CEP-701 peroxy impurity levels, which agreed with those obtained by an HPLC assay method. The modified ASTM E 299-08 method has important applicability in the pharmaceutical industry as a method that can be used for preliminary screening of excipients and new formulations to predict potential oxidative degradation reactions.

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Thesis Staub, Stephanie Anne, University of Kansas
URI http://hdl.handle.net/1808/26161
https://kuscholarworks.ku.edu/handle/1808/26161
QUANTIFICATION OF TRACE LEVELS OF ACTIVE
Adobe Acrobat Document 3.1 MB
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      • CMC and Croscarmellose Sodium
      • Converted Starch
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      • Modified Starch
      • Starch
      • Sugars
      • Sugar Alcohols
    • Petrochemicals
      • Acrylic Polymers
      • Glycols
      • Mineral Hydrocarbons
      • Mineral Oils
      • Mineral Waxes
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      • Polyethylene Glycol (PEG)
      • Povidones
      • Propylene Glycol
      • Other Petrochemical Excipients
    • Oleochemicals
      • Fatty Alcohols
      • Glycerin
      • Mineral Stearates
      • Pharmaceutical Oils
      • Other Oleochemical Excipients
    • Proteins
  • Applications
    • 3D Printing – Drug Carrier
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      • Binder
      • Coating
      • Colour / Color
      • Coating Systems and Additives
      • Controlled Release Excipient
      • DC excipient
      • Disintegrant / Superdisintergrant
      • Drug Carrier
    • Emulsifier – Glidant
      • Emulsifier
      • Excipient for Inhalation
      • Filler
      • Film former
      • Flavour / Flavor
      • Glidant
    • Lubricant – Preservative
      • Lubricant
      • Nanotechnology
      • Orally Dissolving Technology Excipient
      • Pellet
      • Plasticizer
      • Preservative
    • Solubilizer – Viscocity Agent
      • Solubilizer
      • Speciality Excipient
      • Surfactants
      • Suspension Agent
      • Sustained Release Agent
      • Sweeteners
      • Taste Masking
      • Topical Excipient
      • Viscosity Agent
  • Sources
    • Handbook of Pharmaceutical Excipients – 9th Edition
    • EINECS Numbers
    • Excipient DMF List
    • Excipient cGMP Certification Organisations
    • FDA Inactive Ingredient List
    • FDA GRAS Substances (SCOGS) Database
    • Excipient E-Numbers
    • Whitepapers / Publications
    • Contract Development|Contract Manufacturing
  • Suppliers
    • A-B
      • ADM
      • ARMOR PHARMA
      • Ceolus™ & Celphere™
      • Ashland
      • BASF
      • Beneo – galenIQ
      • Biogrund
      • Budenheim
    • C-G
      • Captisol
      • Croda
      • Cyclolab
      • DFE Pharma
      • DuPont Pharma Solutions
      • Evonik
      • Fuji Chemical Industries
      • Gattefossé
      • Gangwal Healthcare
    • I-O
      • ingredientpharm
      • IOI Oleochemical
      • JRS Pharma
      • Kerry
      • KLK Oleo Life Science
      • Lactalis Ingredients Pharma
      • Lipoid
      • Dr. Paul Lohmann
      • Lubrizol
      • Magnesia
      • MEGGLE Excipients
      • Nagase Viita – Pharmaceutical Ingredients
      • Nordic Bioproducts Group
    • P-Z
      • Pfanstiehl
      • pharm-a-spheres
      • Pharma Line
      • PMC Isochem
      • Roquette Pharma
      • Seppic
      • Shin-Etsu
      • Sigachi Group
      • Südzucker AG
      • VIKRAM THERMO
      • Zerion Pharma
      • ZoomLab® – Your Virtual Pharma Assistant
  • Inquiries
    • Product Inquiry
    • Tailored Tableting Excipients
      • Tailored Film Coating
  • Events
    • Overview Pharmaceutical Webinars
    • Videos CPhI Frankfurt 2025
    • CPhI China 2024
    • ExciPerience – The great excipient event!
  • All4Nutra

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Copyright: PharmaExcipients AG