HWI group

The HWI group is an innovative and independent partner of the pharma, medtech and biotech industries. Today we offer our services for active ingredients, medical devices and associated products at our sites in Rülzheim (HWI pharma services GmbH), Appenweier (HWI development GmbH) and Planegg (HWI regulatory services GmbH).

Development and validation

We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, ready-to-use products and medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.

Quality control

In our GMP- and FDA-certified laboratory we conduct analytical testing as part of batch release for active ingredients, medicinal products and drug-related medical devices. We can undertake all your stability testing: storage, analytical testing and stability report as part of ICH studies and follow-up studies.

Drug development

The active ingredient is at the heart of our risk-based formulation development. Its properties have a critical influence on the quality of the product. By using statistical design of experiment (DoE) we offer an efficient pharmaceutical development that completely fulfils the requirements of quality by design.

Reference standards
Reference standards

Reference standards

Qualification of pharmaceutical reference standards:
primary and working standards

Experience

Our 28 years of experience in the manufacture, isolation, purification and qualification of pharmaceutical reference standards for quality control make us your trusted partner for reference standards.

In our GMP- and FDA-certified lab, we qualify our reference standards according to the latest scientific and technical knowledge, thereby meeting the current legal and regulatory requirements.

Choose the most suitable standard for your purpose from our portfolio.

Primary standards

Within the scope of qualifying primary standards we also test the identity, content and purity.

Identity testing

Identity testing using spectroscopic methods:

1H-NMR and 13C-NMR spectroscopy, recording of coupled spectra as required
Mass spectroscopy
UV and/or IR spectroscopy

Assay

Assays using two independent methods:

Quantitative NMR or titration as an absolute method
Chromatographic purity using validated HPLC or GC separation systems including other impurities such as
- Residual solvents (determination by validated GC separation systems)
- Water content (Karl Fischer titration)
- Inorganic impurities

Retesting the primary standards regularly ensures the contents over a defined period.

Dossier

The dossier on the primary standard contains the results of qualification including validation data, an interpretation of the spectroscopic data and an assessment of the specified contents. It can be directly incorporated in CTD modules 3.2.S.5 or 3.2.P.6.

Certificate of analysis

Besides the qualification results, the batch-specific certificate of analysis also includes details on the shelf life and recommended storage conditions as well as sample spectra and chromatograms.

Standards for research
and development
(R&D standards)

Our R&D standards are tested using chromatographic and spectroscopic methods and come with a batch-specific certificate of analysis.

Standards for identity
and purity testing
(ident-purity standards)

Ident-purity standards come with proof of identity, determined chromatographic purity and a batch-specific certificate of analysis.

Standards for assay
(assay standards)

We offer assay standards for pharmaceutical quality control as primary reference standards or working standards derived therefrom.

Working standards

We offer a wide range of working standards for quality control at an excellent price–performance ratio. The content of our working standards is derived from a qualified primary standard using a validated process. The identity is also verified.

Regular retests and pre-portioning in quantities for an analysis period ensure the stability of the working standard.

Please see our product range for the instant availability of our working standards. Other working standards can be supplied upon request.

Besides the qualification results, the batch-specific certificate of analysis also includes details on the shelf life and recommended storage conditions as well as sample spectra and chromatograms.

#referencestandard

Identity and purity standards

As part of the qualification of identity and purity standards we test identity and purity. Identity testing using spectroscopic methods:

1H-NMR and 13C-NMR spectroscopy, recording of coupled spectra as required
Mass spectroscopy and/or UV and/or IR spectroscopy

Purity testing via chromatographic purity using HPLC or GC separating system.

Besides the qualification results, the batch-specific certificate of analysis also includes details on the recommended storage conditions as well as sample spectra and chromatograms.