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Dissolution Rate Testing

Dissolution Rate Testing

An essential part of the quality control of solid dosage forms is to determine the dissolution rate. The pharmacopoeias describes different apparatuses, suitable for different tasks (Ph. Eur. 2.9.3 and USP ICH harmonized in Q4B Annex 7R2 and Ph. Eur. 9.2.42, 2.9.43 and ). Due to the high number of devices, continuous qualification work and the great experience ensure that both, time-critical analysis e.g. batch release testing as well as problem solving can be performed.

Our services in detail:

  • Semi-automated dissolution rate systems in accordance with USP I (basket) and USP II (paddle)
  • Dissolution Rate systems according to USP IV (flow-through cells)
  • Release testing of highly effective substances in our safety lab
  • Monitoring according to your needs by LC / UPLC, CE, GC as well as spectrophotometer
  • Great experience in method development and validation as well as batch control testing for all dosage forms (immediate-, extended-, and delayed-release)

GBA PHARMA GMBH

SPECIAL SERVICES:

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