DSI-pharm – Your Partner for Pharmaceutical Analyses!

Analytical and Regulatory Consulting

Analysis of Medicinal Cannabis

Stability Testing

Laboratory Equipment

Batch Release Testing and EU Re-tests

Method Development and Method Validation

DSI-pharm – a Tentamus company

As a GMP certified laboratory we support our clients in regards of pharmaceutical quality control quickly, reliably and without complications. As a partner of pharmaceutical industry DSI-pharm shoulders responsibility for R&D projects and operates as an extension of our clients’ quality control (QC) workbench. Needs based, efficient, and with short turnaround times – since 1995.

Our Services – Your benefit:

Analytical consulting
Method development and method validation
Stability testing
Batch release testing and EU re-tests

Analytics and consulting

At the GMP-certified pharmaceutical laboratory, medicinal and related products, such as food supplements and medical devices, are tested by applying modern instrumental analyses. These include chromatography (UHPLC, HPLC, IC HS-/GC, DC) as well as pharmacopoeia-specified tests. The contract laboratory offers a combination of

well-researched analytical and regulatory consulting,
project management and
practical lab work.

DSI-pharm knows the legal requirements and how authorities interpret them in day-to-day business. This allows development of economical, targeted pharmaceutical analytics for every product.

Laboratory with narcotics licence and manufacturing authorisation

The GMP laboratory sets the highest standards for operations, as verified by the GMP certification. In addition to this, DSI-pharm has been granted a licence pursuant to section 3 of the German Narcotic Drugs Act as well as a manufacturing authorisation for testing and batch release in accordance with Directive 2001/83/EC. The pharmaceutical laboratory provides QP-certified batch release testing to assist qualified persons in the process of batch release. Excellent services at a fair price – for DSI-pharm, this is all in a day’s work.

News

Reduction of limits for prohibited substances chloramphenicol and nitrofurans (additionally newly demanded: Nifursol)

The “minimum performance limits” (MRPL) for the prohibited antibiotic substances chloramphenicol (MRPL = 0.3 ppb) and nitrofuran metabolites (MRPL = 1.0 ppb) in animal foods such as honey, which have been in force in the EU for many years, have been replaced by “reference points for action” (RPA) and tightened significantly. The new RPA are ... Continued

The synthesis lab at aromaLAB GmbH is now DIN EN ISO 9001 accredited

aromaLAB GmbH is proud to announce that aromaLAB’s synthesis department achieved a successful certification of DIN EN ISO 9001 for the development and production of unlabelled and isotopically labelled standards. These aroma standards are used for research and analytical purposes by well-known international food companies, breweries and universities. The ISO 9001 certification was a ... Continued

Authenticity of soluble coffee ("instant coffee")

The authenticity of food is increasingly the focus of the food industry and third-party monitoring. The proof of an authentic food product is provided by a combination of different measures such as documentation along the supply chain, audits, risk analysis, avoidance strategies, but also by actual chemical analysis of products. For soluble coffee (“instant coffee”), ... Continued

Labocor Analítica expands its ENAC scope in food and feed

Labocor Analítica achieves an important extension of its ENAC scope in food and feed, as a result of its commitment to the continuous improvement of all its analytical services. Labocor Analítica has achieved the extension of its ENAC scope in the following tests: Fat by gravimetry for Feed and its raw materials, Cereals and derivatives, ... Continued

New developments in HACCP by the EC

The European Commission has issued a new communiqué which aims to lay the foundations and provide tools to instil a Food Safety Culture in the EEA, which goes beyond the simple implementation of a HACCP-based system. With the entry into force of COMMISSION REGULATION (EU) 2021/382 of 3/03/21 amending the Annexes to Regulation (EC) No ... Continued

New version of efficiency standard UNE EN 13624

On 27 July 2022, the new version of the efficiency standard UNE EN 13624 was published. This standard cancels and replaces Standard EN 13624:2013. Chemical antiseptics and disinfectants. Quantitative suspension test for the evaluation of fungicidal or levuricidal activity in medicine. Test method and requirements (phase2, step1) The standard applies to products used in ... Continued

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