Metadoxine

QUALITY CONTROL

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Union Pharma continuously improves the quality management through the implement of a complete, advanced, scientific quality management system according to current GMP, national and international standards.

 

Instruments

Instruments

Model

HPLC

Agilent 1100/1200

DAD/RID/VWD/CAD Detector

Shimadzu LC-10AT/LC-20AT

GC

Agilent 6850/6890N

Shimadzu GC-2013

Preparative HPLC

Agilent 1260 infinity

LC-MS

Agilent 6310

IR

Nicolet 360 FTIR

Shimadzu IR Prestige-20

ICP

Perkin Elmer 7000

TOC Analyzer

Shimadzu TOC-Vcph

UV

Agilent 8452E

DSC

Mettler Toledo DSC1

Automatic Digital Polarimeter

WZZ-2S/SGW-2

Potentiometric Titrimeter

Metrohm 702/846/876/Mettler Toledo T50

KF Titrimeter

Metrohm 787/870/876/Mettler Toledo DL30

Metrohm 890

 

Analysis Capabilities

 

Analytical Method Development & Validation

Impurity Identification and Profiling

 

Analytics / In Process Control

 

The role of the analytical department in Union Pharma’s business is rapidly gaining importance. This mainly to fulfill the demands in the strictly controlled production of Pharmaceutical, Intermediates and APIs.

 

To ensure the quality and determine the impurity profiles of products, intermediates and starting materials mostly chromatographic (HPLC, GC, TLC, Capillary Electrophoresis) or titrimetric methods are utilized.

 

Analytical methods are often transferred from the customer and validated according to internationally accepted guidelines. If no validated methods are available, Union Pharma develops the necessary methods and transfers them from the development to QC labs at plants. Accompanying this development is often the identification and synthesis of all important impurities for their usage as standards.

 

We have experienced analysts for methods development, validation and analysis. All compounds, from raw materials to intermediate to final products, are analyzed in the QC department of Union Pharma. Further support during the development and optimization phases of a project comes from the wide variety of different analytical methods which are available on our R&D center.

 

   

Exhibitions

2015 CPHI Worldwide France     

Stand 16B87 at CPHI Worldwide France


2015 CPHI Worldwide Russia    

Stand 379 at CPHI Worldwide Russia

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