PHARMACEUTICAL ANALYTICS

CURRENTA offers a whole host of analytical services for pharmaceutical production. As a GMP-certified laboratory that is also registered with the FDA, we support our customers throughout the development and quality control processes for pharmaceutical products.

Our pharmaceutical analysis specialists have many years of experience in developing, optimizing and validating methods in line with ICH guidelines. We conduct the relevant tests under GMP conditions and in line with international pharmacopoeia. We are also happy to integrate your methods or develop methods geared specifically to your needs.

We enter into technical agreements with you to ensure the necessary legal framework is in place. We also conclude confidentiality agreements as a matter of course.

OUR PHARMACEUTICAL ANALYSIS SERVICES

PHARMACOPOEIA / RAW MATERIAL TESTING

For quality control purposes, we perform identity, purity and content testing in line with the relevant pharmacopoeia, your own requirements or – in consultation with you – our validated in-house methods.

ICH STABILITY STUDIES

We store your pharmaceutical products in line with the ICH guidelines for various climate zones and we have a wide range of analytical methods at our disposal for subsequent testing of your samples.

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS

We develop appropriate analytical methods for your product quality control procedures, gearing the selection of analysis techniques and the scope of validation to your requirements.

ELEMENTAL ANALYTICS IN LINE WITH ICH Q3D

We perform standardized element screenings for you that serve as a basis for risk assessments relating to the elemental impurities of pharmaceuticals in line with the new ICH Q3D guideline. In addition to this, we offer you customized solutions for ongoing checks on pharmaceuticals or feedstocks.

CLEANING VALIDATION

Our expertise in numerous analysis techniques helps you test your production facilities for residues.

DEFECT ANALYSIS

We test active ingredient crystals and medical products for defects. We also analyze the particles found to define their type, distribution and size.

POLYMORPHY

We use X-ray diffractometry for unambiguous, non-destructive identification of the various polymorphic substances in pharmaceutical products. The relevant tests are possible under various environmental conditions, e.g. at different temperatures or humidities.

TESTING OF PACKAGING MATERIALS

Pharmaceuticals are in direct contact with process and packaging materials. Since plastics are increasingly used in packaging materials, we offer extractable studies that enable the transfer of additives and degradation products to the relevant pharmaceutical to be assessed.

ELUCIDATION OF SECONDARY COMPONENTS

Products on the market may contain secondary components. We offer structural elucidation of these secondary components so as to enable a risk assessment.

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