Release testing

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GMP-Compliant Release Testing

Release testing is a key component of pharmaceutical quality control. It ensures that raw materials, intermediates, and finished medicinal products meet all specified quality requirements before further processing or commercialization. HHAC supports pharmaceutical companies, medical device manufacturers, and cosmetics companies with GMP-compliant release testing. Through the use of modern analytical techniques, validated testing procedures, and short turnaround times, HHAC delivers accurate and reliable results to support safe batch release.
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The need for rapid results is particularly critical in release testing. To accelerate internal processes and enable flexible responses to market demands, HHAC offers individually agreed delivery deadlines. For established methods and predefined parameters, release testing can often be completed within three days. In special cases, through coordination across multiple specialist departments, analyses can be completed within 24 hours. All workflows and documentation are fully GMP-compliant. Customer-specific templates, evaluation sheets, and protocols can be seamlessly integrated into HHAC’s laboratory documentation system, minimizing administrative effort for clients.
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What Is Release Testing?

Release testing is performed to verify that a product conforms to established specifications. Before a batch is released, defined quality attributes are analytically evaluated. These may include:

  • Identity
  • Assay (active ingredient content)
  • Purity
  • Related substances
  • Residual solvents
  • Water content
  • Dissolution
  • Physical parameters
  • Microbiological parameters

The resulting data provide the basis for the final quality assessment and release decision by the manufacturer and/or the Qualified Person (QP).

Our Release Testing Services

HHAC performs release testing for a wide range of product categories.

Raw Materials and Active Pharmaceutical Ingredients (APIs)

Testing of:

  • Identity
  • Assay
  • Purity
  • Water content
  • Physicochemical parameters

Testing is performed according to:

  • European Pharmacopoeia (Ph. Eur.)
  • United States Pharmacopeia (USP)
  • Japanese Pharmacopoeia (JP)
  • German Pharmacopoeia (DAB)
  • Customer-specific specifications
Intermediates

In-process quality control during manufacturing to ensure the suitability of subsequent process steps.

Customer-specific templates, evaluation sheets, and protocols can be seamlessly integrated into HHAC’s laboratory documentation system, minimizing administrative effort for clients.

Finished Pharmaceutical Products

Release testing for:

  • Tablets
  • Capsules
  • Powders
  • Solutions
  • Suspensions
  • Semi-solid dosage forms

Including all relevant quality parameters.

Medical Devices and Cosmetics

Analytical testing to confirm compliance with defined product specifications and quality requirements.

Available Analytical Techniques

A broad range of analytical methods is available for release testing.

Chromatographic Methods

High-Performance Liquid Chromatography (HPLC)

Used for:

  • Identity testing
  • Assay determination
  • Purity testing
  • Related substances analysis
Gas Chromatography (GC)

Used for:

  • Residual solvent analysis
  • Volatile impurity testing
  • Assay determination
Thin-Layer Chromatography (TLC)

Used for:

  • Identity testing
  • Purity testing
  • Assay determination

Spectroscopic Methods

  • Infrared Spectroscopy (IR)
  • UV/Visible Spectroscopy (UV/Vis)

Used for identity verification and assay determination.

Classical Wet Chemical Methods

  • Karl Fischer titration
  • Potentiometric titration
  • Complexometric titration
  • Acid value determination
  • Peroxide value determination

Classical Physical Methods

  • Friability
  • Hardness
  • Density
  • Osmolality
  • Loss on Drying
  • Sulfated Ash
  • pH measurements
  • Conductivity measurements

Dissolution Testing

Evaluation of the drug release behavior of medicinal products according to pharmacopoeial and product-specific requirements

Method Transfer and Method Optimization

Not every release test is based on an already established analytical procedure. HHAC supports customers with:

  • Method optimization
  • Method development
  • Method validation
  • Method transfers
  • Transfer protocols and transfer plans

These services enable new products and manufacturing processes to be rapidly integrated into routine GMP operations.

Why HHAC?

Your GMP Contract Laboratory for Release Analytics

Since 1992, HHAC has supported companies with analytical challenges in development, manufacturing, and quality control. During this time, experience has been gained with more than 400 active pharmaceutical ingredients and excipients across a wide variety of dosage forms.

Your Benefits

  • GMP-compliant documentation
  • Fast delivery timelines
  • Dedicated project manager as your point of contact
  • Experience with more than 400 active ingredients
  • Modern laboratory equipment
  • Integrated method transfer and validation services
  • Support during quality control capacity bottlenecks

FAQs

Release testing verifies that a raw material, intermediate, or finished medicinal product meets predefined quality requirements and can be approved for further use or commercialization.

HHAC performs release testing for active ingredients, excipients, intermediates, finished pharmaceutical products, medical devices, and cosmetics.

Delivery timelines depends on the scope of testing and the analytical methods required. For established procedures, testing can often be completed within three working days. Shorter delivery timelines may be possible for urgent cases.

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Depending on the product, chromatographic, spectroscopic, wet chemical, physical or dissolution testing methods may be employed, including HPLC, GC, IR, UV/Vis spectroscopy, and Karl Fischer titration.

Yes. Existing analytical methods can be transferred, verified, and integrated into routine GMP operations through a structured method transfer process.

Yes. In addition to release testing, HHAC provides support for method development, method optimization, and validation in accordance with ICH requirements.

Yes. All analyses, evaluations, and reports are performed and documented in compliance with GMP requirements. Customer-specific forms and templates can also be incorporated.

Yes. Accelerated delivery timelines can be arranged for critical batches and time-sensitive projects.

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