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Dissolution

GBA Group - Dissolution

Determine the dissolution rate

The determination of dissolution rate is an essential part of quality control.

Dissolution testing aims to determine the rate at which an active pharmaceutical ingredient (API) is released from its formulation under standardized conditions. In practice, the quantity of drug dissolved in the dissolution medium at time X after addition of the FDF or API is determined. The amount of time required to dissolve the desired amount of API can vary significantly depending on the product being tested.

In the case of immediate release dosage forms, the test is usually carried out at a single point in time (usually 45 minutes or less). Multiple samples are collected in the case of extended or delayed release.

So-called dissolving profiles are also possible. For this purpose, the active substance content in the dissolution medium is determined at several time points and displayed as a function of time.

The results obtained can be used to indicate batch-to-batch consistency and consistent efficacy of the product. In addition, batch homogeneity, compliance and stability can be tested.

The dissolution rate is usually measured for the following dosage forms:

  • Solid dosage forms (e. g. capsules, tablets, medicated chewing gums)
  • Pure solid susbstances / active substances in preparations presented as powders or granules (apparent dissolution rate)
  • Lipophilic dosage forms (e. g. suppositories, soft capsules)
  • Transdermal patches

The GBA Group is experienced in testing all of the following dosage forms.

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 Group team offers a variety of different services in the following Areas.

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GBA Pharma Labs - Packaging Material Testing

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GBA Pharma Labs - Elemental Impurities Testing

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GBA Pharma Labs - iCEF

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GBA Pharma Labs - Protein characterization

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GBA Pharma Labs - Limit test for DEG and EG by GC

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