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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.

ACTIVE PHARMACEUTICAL INGREDIENTS – MADE IN GERMANY

Controlled quality

Ensure quality – assume responsibility

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

Quality control’s range of services

Chromatography

Molecular spectroscopy

Inorganic analytics

Physical analytics

Our service: contracted analyses