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ACTIVE PHARMACEUTICAL INGREDIENTS – MADE IN GERMANY

Arevipharma puts focus on the process development of stable and robust chemical synthesis routes, and its quality management to ensure its Active Pharmaceutical Ingredients (API) are of the highest quality.


Controlled quality

Accuracy and reliability distinguish the analytical results of quality control. The quality of API manufactured by Arevipharma has sealed their good reputation among customers. Row materials, intermediates, API and primary packaging are checked in accordance to specification and communicated and professionally documentated in an efficient manner.
Arevipharma develops, validates and transfers new methods of analysis, this is done also in the field of trace analysis, e.g. for potential genotoxic substances. Thorough reporting is included, of course. The Quality control department carries out structural elucidation of by-products and degradation products, quality control qualifies reference substances and performs API stability tests according to international guidelines.



Ensure quality – assume responsibility

Inspections by the following authorities have confirmed Arevipharma’s GMP compliance:

  • The State Directorate of Saxony (Landesdirektion Sachsen) (GMP certification)
  • The U. S. Food and Drug Administration (FDA)
  • The Korean Food and Drug Administration (KFDA)
  • The Japanese Authority for Medicinal Products and Medical Devises (PMDA)
  • The Brazilian Authority responsible for health surveillance (ANVISA)
The department Regulatory Affairs is responsible for compiling and keeping up-to-date globally issued regulatory API dossiers, it also provides our customers with all information and data required.

Its effective system for quality management helps Arevipharma to guarantee its products meet Arevipharma’s highest demands on quality. The system complies with the current requirements of the Pharmaceuticals and Active Agent Manufacturing Ordinance (AMWHV) as well as the international regulations of Good Manufacturing Practice (GMP) according to ICH Q7 and the implementation of these regulations in the EU member states (EU GMP guide part II) and in the Unites States of America (21 CFR 210 & 211), respectively.


Quality control’s range of services

Chromatography

High performance liquid chromatography (HPLC)
  • various detectors such as UV, diode array
  • mass spectrometer UHPLC
Gas chromatography (GC)
  • various detectors such as FID, TCD, NPD, mass spectrometer
  • various options for injection as on-column, programmed temperature vaporizing, headspace GC, GC after derivatisation
Thin layer chromatography (TLC)
  • DC automatic sampler, digital documentation
  • evaluation with scanner


Molecular spectroscopy

NMR spectroscopy
  • 500 MHz-NMR spectrometer
  • 1H-, 13C-, 15N- und 31P-NMR spectroscopy
  • special pulse technologies, multidimensional NMR for structure elucidation
  • quantitative assays using qualified reference standards
Mass spectroscopy
  • mass spectrometer combined with HPLC, GC and ICP
IR spectroscopy
  • Fourier transform infra red spectroscopy (FT-IR) with heatable ATR unit
UV-VIS spectroscopy
  • spectroscopy in the ultraviolet and visible range for solutions


Inorganic analytics

Determination of elements
  • atomic absorption spectroscopy: flame, graphite furnace AAS
  • element mass spectrometry using inductively coupled plasma mass spectrometry (ICP-MS)
Miscellaneous
  • titrations: acid, base, potentiometric, Redox, argentometric
  • Karl Fischer titration, ash determination, ash content and loss on drying


Physical analytics

Particle size determination
  • laser diffraction spectroscopy (wet and dry dispersion)
  • sieve analysis by means of elutriation (air jet sieving)
calorimetric analyses
  • dynamic differential calorimetry (DSC)
Miscellaneous
  • bulk density, tap density
  • melting point determination
  • pH value determination
  • turbidimetry
  • solution colour index determination


Our service: contracted analyses


At Arevipharma highly qualified staff analyse chemical and pharmaceutical intermediates and API supported by extensive analytical equipment at the highest possible technical level. Analysis results are documented in accordance with national and international standards and regulations. Efficient processes enable the quality control team to respond flexibly to requests and to deliver excellent quality even for short-term orders.

Business Development

Carsten Schröpfer

Tel.: +49 (0)351 8314-1121
E-Mail: carsten.schroepfer@arevipharma.com

Business Development

Dr. Christian Steidl

Tel.: +49 (0)351 8314-1800
E-Mail: christian.steidl@arevipharma.com

Arevipharma GmbH
Meißner Straße 35
D-01445 Radebeul
Web: www.arevipharma.com
Telefon: +49 (0)351 8314-0
Telefax: +49 (0)351 8314-2100
Geschäftsführung
Herr Dr. Hendrik Baumann
Herr Sebastian Breyer
Handelsregister:
Amtsgericht Dresden, HRB 23835
USt-IdNr.: DE 240935001
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