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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

News and events

 

News and events

ICP-MS

The USP <231> article about “Heavy metals limit test” is being replaced. On January 1, 2018, the Pharmaceutical Industry, under the guidelines set by the ICH and the USP, will be required to use ICP/MS (Inductively Coupled Plasma/ Mass Spectrometry) for the determination of elemental impurities in new finished drug products, new drug products containing existing drug substances, and excipients.

Quinta-Analytica has implemented an ICP-MS system (Agilent) for testing of contents of elements in the pharmaceutical (and other) matrices. The system is operated fully under GMP and FDA rules.

Automatic Amino Acid Analyzer

Quinta purchased an automatic analyzer Sykam S-433 (Watrex s.r.o.) which allows for accurate and sensitive quantification of amino acids or ninhydrin-positive impurities in API samples, physiological samples or in protein or peptide hydrolysates. The method relies on ion-chromatography with on-line post-column derivatization with ninhydrine.

Acquisition by Genesis

Genesis Private Equity Fund III (GPEF III), a private equity fund advised by Genesis Capital, has completed the acquisition of 75% shares in the company QUINTA-ANALYTICA. The remaining 25 % are held by two managers who are staying with the company.
The entry of GPEF III into QUINTA-ANALYTICA laid down a stable foundation of a highly competitive company with international reputation and further strengthens its stability and growth possibility.

ICSE 2016

Quinta-Analytica will take part in the CPHI/ICSE exhibition on 4-6th October 2016 in Barcelona. Our stand nr is 3J78, located in Hall 3.

Bioeurope 2016

In November 7-9, Cologne (Germany) will host a partnering conference Bioeurope Worldwide. Quinta-Analytica will participate as well.

FDA

Clinical Department successfully passed FDA audit. Inspection was performed from 15 to 21 September.

Synthesis and characterization of identified impurities

Analytical R&D department has large expertise in structure elucidations of unknown impurities from production and stability studies of pharmaceutical products. This team is now capable of chemical synthesis of these compounds to confirm the structure and/or establish an analytical reference standard of such impurity.

 

 

 

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