Stability studies

Since its inception, Quinta-Analytica has been providing a complete implementation of a Stability Study with active substances and pharmaceutical forms. These studies are again carried out within the framework of the GMP and according to the ICH guidelines. Since 1999, more than 200 Stabilization Studies have been measured or under way in our company. We offer the following services:

• Stability Protocols
  
• Complete analytical testing
• Large capacity for measuring stability samples
• Stability modes:
• • 2-8 ° C
  • 25 ° C / 60% RH, 2 rooms, area 40m 2
  • 30 ° C / 65% RH, 1 room, area 16m 2
  • 30 ° C / 75% RH, 1 room, area 16m 2
  • 40 ° C / 75% RH, 2 rooms, area 32m 2
  • photostable box
  • transport study
• Continuous and summary reporting of stability results.

Analyses of highly potent substances

We use Highly Potent Substance Laboratory (HPSL) for high-potency analyzes. It consists of several laboratories, hygienic loops and is completely autonomous in terms of personnel and equipment. It can work independently of other projects, and with special regard to safety.Analyzes of highly active substances represent a large part of the capacity of separation of pharmaceutical analyzes and we have several years of experience with them.

Quality control, release analyses

Quality control within GMP is an integral part of pharmaceutical production. Although Quinta-Analytica does not have a pharmaceutical product line, it owns a GMP certificate and a production license. This is why our company is approved for quality control and also for analytical testing of release testing. It is testing products destined for the EU market, which must be so-called "released" to EU countries.

Quinta-Analytica has been a well-established and established batch release testing company that has been manufactured outside of the EU - "import testing". We do this testing even for the world's largest pharmaceutical manufacturers.

Support of formulation development

During the development of the dosage form, a large number of test batches are produced in which various important parameters such as active ingredient content, purity, water content, hardness, etc. have to be analyzed. Reliable and rapid analytical results are very important for the proper development of the dosage form. Quinta-Analytica is able to analyze a large number of such samples in time and at the appropriate quality thanks to the rapid and flexible planning of analytical work. Results reports can be requested in a quick, well-arranged spreadsheet form.

Support of manufacturing process validation

Validation of the manufacturing process of the pharmaceutical form is one of the most important part of the manufacturing process under Good Manufacturing Practice (GMP). The manufacturing process must also be validated within this practice. A large number of samples are produced during the process, which must be analyzed by approved and validated methods. The capacity of analytical laboratories of a given pharmaceutical manufacturer sometimes has limited capacity, and in this case, Quinta-Analytica can help and analyze these samples.

Quinta-Analytica has many years of experience in this field, and many pharmaceutical forms in the world have been validated using our analytical services.

Analyses of inhalation products

Quinta-Analytica provides testing of inhalation products administered via dry powder inhalers. Our special laboratory with controlled environment (temperature and humidity) performs analyzes of these products according to CL and Ph. Eur. monograph Preparations for inhalation 2.9.18 and 0671, Inhalanda.