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Chemical and Physical Testing

A team of around thirty experts and laboratory personnel conducts extensive analytical services for customers from the pharmaceutical, medicinal products and cosmetics industry – always in compliance with the relevant regulations. Whether limit testing, purity tests, identification tests or the determination of content, melting point and osmolality – Labor LS offers its customers pharmacopoeial test methods, whose range is extensive in terms of both quality and quantity. This applies to tests according to the European Pharmacopoeia as well as the U.S. and Japanese pharmacopoeias (USP/NF and JP, respectively). Thanks to our many years of experience, we offer you the optimal efficiency in the handling of a large number of raw materials. We will be pleased to realise customer-specific requirements. The combination of a wide range of testing equipment and methods as well as our personnel's expertise guarantees the highest quality in both method validation and product testing.

Water Analysis

Whether used for pharmaceutical purposes (“pharmaceutical water”) or as drinking water, Labor LS uses a large spectrum of chemical, physical and microbiological methods to analyse the quality of water.

Whether used for pharmaceutical purposes (“pharmaceutical water”) or as drinking water, Labor LS uses a large spectrum of chemical, physical and microbiological methods to analyse the quality of water. In this way, it is possible to rule out or exactly determine potential contaminations.

In the field of chemical water analysis, we  test purified water and water for injections according to pharmacopoeial specifications for “Total Organic Carbon” (TOC) and conductivity as well as for heavy metals, nitrate, visible and sub-visible particles and other specified parameters. In addition, we conduct nitrate tests according to the German Drinking Water Ordinance (TrinkwV).

 

Your contact persons:

Dr rer nat Stephanie Bank 
Pharmacist

+49(0)9708/9100-400
stephanie.bank@labor-ls.de

 

Sandra Schmitt 
PTA

+49(0)9708/9100-495
sandra.schmitt@labor-ls.de

Titrations

Titration is still an indispensable method of determining contents in chemical and physical analyses.

Titration is still an indispensable method of determining contents in chemical and physical (s.o.) analyses. The scope offered by Labor LS comprises classical hand titration, potentiometric titration and titrations with ion-selective electrodes as a part of content and purity analyses. In addition, we routinely carry out semi-micro determinations of water according to Karl Fischer.


Your contact person:

Eva-Maria Schlereth
Pharmacist
+49(0)9708/9100-596
evamaria.schlereth@labor-ls.de

Chromatography/Electrophoresis

High-performance liquid chromatography (HPLC) is used for the routine evaluation of raw materials, active pharmaceutical ingredients (APIs) and finished products.

High-performance liquid chromatography (HPLC) is used for the routine evaluation of raw materials, active pharmaceutical ingredients (APIs) and finished products. Next to the determination of content and purity according to pharmacopoeial methods, the focus of this methodology is on validations, method developments and method transfers specifically tailored to customers' products. The detection methods available to our customers are diode array (DAD), UV/Vis, refractive index (RI), pulsed amperometric and fluorescence detectors.

In the field of gas chromatography (GC), our service portfolio comprises tests for residual solvents, content and purity testing on raw materials, APIs and finished products. In addition, we offer comprehensive method developments and validations as well as the transfer of your methods to Labor LS. In the field of gas chromatography (GC), we use gas chromatographs with headspace and liquid injection.

The electrophoretic methods we offer in the context of development, validation and transfer include gel-based tests (agarose gel electrophoresis, SDS PAGE, isoelectric focusing) according to pharmacopoeial methods or to your own requirements.

Your contact persons:

 

Dr rer nat Marcus Kehrel
Pharmacist
+49(0)9708/9100-439
marcus.kehrel@labor-ls.de

Pharmaceutical Technical and Instrumental Procedures

The guidelines of GMP and GLP form the relevant foundations in the manufacture and testing of pharmaceutical products, especially in the application of pharmaceutical-technological methods.

The guidelines of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) form the relevant foundations in the manufacture and testing of pharmaceutical products, especially in the application of pharmaceuticaltechnical methods.

The expertise of Labor LS is based on many years of experience, in particular in the testing of visible and sub-visible particles according to methods 2.9.19 and 2.9.20 of the Ph Eur as well as the appropriate chapters of the USP/NF. Also  classical test methods — such as disintegration time, release of active ingredients and friability — are performed for the products of our customers in accordance with the requirements of the pharmacopoeias. In addition, we also provide you with a number of other instrumental methods, including pH value determination, osmolality and optical rotation as well as the determination of melting temperature.

Your contact persons:

Dr rer nat Joanna Ruppel 
Pharmacist

+49(0)9708/9100-451
joanna.ruppel@labor-ls.de

 

Sandra Schmitt 
PTA

+49(0)9708/9100-495
sandra.schmitt@labor-ls.de

Spectroscopy

We conduct IR and UV/Vis spectroscopy with modern equipment. Our customers can rely on a wide range of pharmacopoeia methods, including enzymatic determinations according to customer specifications.

We conduct IR and UV/Vis spectroscopy with modern equipment. Our customers can rely on a wide range of pharmacopoeial methods, including enzymatic determinations according to customer specifications. In addition, we also establish and validate specific determinations, such as that of hyaluronic acid in different preparations, according to our own in-house method.



Your contact persons:

Dr rer nat Marcus Kehrel
Pharmacist
+49(0)9708/9100-439
marcus.kehrel@labor-ls.de


Eva-Maria Schlereth
Pharmacist
+49(0)9708/9100-596
evamaria.schlereth@labor-ls.de

Development, Transfer and Validation of Methods

Customers are in good hands and offered all-inclusive service at Labor LS. Our portfolio covers the entire process chain from the development of methods to the completion of validations.

Customers are in good hands and offered all-inclusive service at Labor LS. Our portfolio covers the entire process chain from the development of methods to the completion of validations, including the creation of test methods and reports for drug approvals.

Whether critical assays, purity tests or the specific analysis of residues of highly potent substances on surfaces at cleaning validations—Labor LS has many years of expertise and competence in the development and validation of methods.


Your contact persons:

Eva-Maria Schlereth
Pharmacist
+49(0)9708/9100-596
evamaria.schlereth@labor-ls.de

Dr rer nat Marcus Kehrel
Pharmacist
+49(0)9708/9100-439
marcus.kehrel@labor-ls.de

Stability Storage

To test the stability of their products, we offer our customers a comprehensive package of services.

To test the stability of their products, we offer our customers a comprehensive package of services. We take care of the entire logistics, from collection (to be agreed separately) and storage (including or excluding analytics) up to the return and disposal of our customers' samples.
We create precise stability reports, test plans as well as test matrices and implement necessary storages even at short notice. As part of our comprehensive storage concepts, we guarantee the compliance with the highest security levels. Our climate cabinets and chambers, for example, are equipped with emergency generators and are continuously controlled by two monitoring systems.
We can offer the following climatic conditions for your stability tests:

  • -20 °C
  • -80 °C
  • 5 +/- 3 °C
  • 25 °C, 60 % relative humidity
  • 30 °C, 65 % relative humidity
  • 40 °C, 75 % relative humidity
  • 30 °C, 75 % relative humidity
  • 25 °C, 40 % relative humidity
  • 40 °C, 25 % relative humidity (starting end of 2015)
  • Special conditions are possible on request

Your Contact Person:

Dr rer nat Joanna Ruppel
Pharmacist
+49(0)9708/9100-451
joanna.ruppel@labor-ls.de

Dr rer nat Marcus Kehrel
Pharmacist
+49(0)9708/9100-439
marcus.kehrel@labor-ls.de

Special Tests

In addition to the proven standard methods and procedures, we carry out a number of specific special tests.

In addition to the proven standard methods and procedures, we carry out a number of specific special tests, such as, for example, the quantitative determination of hyaluronic acid in liquid preparations, the activity determination of pancreas powder according to Ph Eur or the self-sealing test of containers according to Ph Eur 3.2.9 or USP <1207>, also known as container closure integrity test (CCIT), in defined low pressure / overpressure conditions with visual and UV-spectroscopic detection. In addition, we offer you comprehensive help with your cleaning validations.

 

Your contact persons:

Dr rer nat Marcus Kehrel
Pharmacist
+49(0)9708/9100-439
marcus.kehrel@labor-ls.de

Dr rer nat Joanna Ruppel 
Pharmacist

+49(0)9708/9100-451
joanna.ruppel@labor-ls.de

News

LS opts for a future-oriented corporate structure

Press release dated 23 April 2018


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Events

Raw Materials Used for Biological Medicinal Products

20. / 21. November 2018, Düsseldorf (ECA)


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PharmaLab 2018

20./21.11.2018, Düsseldorf


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Contact

Labor LS SE & Co. KG

Mangelsfeld 4, 5, 6
97708 Bad Bocklet-
Großenbrach

Fon: +49 (0)9708/9100-0
Fax: +49 (0)9708/9100-36
E-Mail: service@labor-ls.de

Infobox

In our Infobox, we make additional information on our company, our service portfolio and our QM certification available to you in a download. 

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