Impurities & working Standards (1)

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In-house Impurities of Pharmaffiliates

• Impurity Synthesis
• Metabolite Synthesis
• Working Standards
• Deuterated Compounds

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• In-house Impurities
• Impurities are unwanted chemicals present in the
  API or FPP arising from normal manufacture.
• Impurities have no therapeutic value and are
  potentially harmful. Therefore they need to be
  controlled.
• A particular manufacturer's manufacturing method
  may lead to unexpected impurities, due to a
  different route of synthesis, different
  reagents, etc.
• Unfortunately no, monographs are developed based
  upon how the API was prepared historically.
• Most of the potential impurities arise during the
  preparation of the API and its subsequent
  degradation.
• Consequently, there is a large focus on the
  control of impurities in the API.
• Genotoxins must be considered carefully due to
  their toxicity at even very low levels.

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When To Specify IMPURITIES

• The ICH Q3 divides impurities into following
  categories.
• Organic impurities (process- and drug-related)
• Residual solvents
• Inorganic impurities
• Metallic impurities

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Advantages of Pharmaffiliates Impurities

• Option to customer for lower pack sizes of 25 mg
  and 50 mg
• Options of Customized pack sizes
• More number of Compounds and largest inventory
  holder presently
• Option of supply/availability of compounds which
  are presently not listed in present
  catalogue
• All the Impurities supplied with complete
  structure elucidation and interpretation
  i.e. IR, NMR , MASS and Chromatographic
  purity along with detailed COA
• Majority of the Impurities are above 98 pure
• Capability of synthesis typical compounds like
  Dimers, Isomers and Unknown
  Impurities
• ISO 17025 USFDA accredited company also
  applied for ISO 34
• Global presence in more than 45 countries

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Pharmaffiliates
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Pharmaffiliates