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Dissolution

Determine the dissolution rate

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. 2.9.42, 2.9.43 and USP <711>). 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)

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs – GMP Testing

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GMP Quality Control

Method Development & Validation

Stability Studies

Extractables & Leachables

Packaging Material Testing

Particle Determination

Elemental Impurities Testing

Microbiology

Regulatory Services

Amino Acid Analysis

Instrumentation

GMP Testing

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