Service Title

Service Description

Pharmaceutical Testing

Research and development, analysis and testing, quality control and more.

Nitrosamines

Naše in-house metody, používající izotopicky značené standardy, je možné jednoduše optimalizovat a použít pro nejrůznější formy léčivých přípravků a substancí.

Detection of N-Nitroso-N,N-dimethylamine (NDMA) in 2018 in Valsartan, a medicine for blood pressure control, followed by similar observations in Losartan-, Ranitidine- and Metformin- containing products led to temporarily limited availability of medications around the globe and initiated massive risk-assessment campaign for all human medicines containing chemically synthesized APIs.

The scope of the risk-assessment campaign and multiple possible root causes of the contamination create imminent need of robust and reliable determination of Nitrosamines content in various types of matrices. Quinta-Analytica decided to contribute to patients’ safety and to support the pharmaceutical industry by developing versatile proprietary ULPC/MS/MS method for quantitative determination of Nitrosamines under full GMP conditions.

The method is based on isotopically labeled internal standard and was inspired by the methods published by the regulatory bodies. Slight modification of its parameters and/or the sample preparation allows the customization to the specific matrix. The method has been successfully applied to APIs, solid dosage forms, solutions for infusion, oral solutions, semi-finished products or excipients.

Our experience goes far beyond N-Nitroso-N,N-dimethylamine (NDMA) determination and, till the date, we have practical experience with eight Nitrosamines which confirms the versatility of the method:

  • N-Nitroso-N,N-dimethylamine (NDMA)
  • N-Nitroso-N,N-diethylamine (NDEA)
  • N-Nitroso-N-methylbutyric acid (NMBA)
  • N-Nitroso-N,N-ethylisopropylamine (NEIPA)
  • N-Nitroso-N,N-diisopropylamine (NDIPA)
  • N-Nitroso-N,N-ethylmethyamine (NEMA)
  • N-Nitroso-N,N-dipropylamine (NDPA)
  • N-Nitroso-N,N-dibutylamine (NDBA)

The solution provided by Quinta-Analytica has proven to deliver the sensitivity required by the interim limits set upon maximum daily intake but is ready for expected strengthening of the limits (down to 30 ppb and even lower). Limit tests will be implemented after the final specification and methodologies will be codified by the regulatory bodies..

Current range of API applications validated by Quinta-Analytica:

Sartans

Valsartan

Losartan Potassium

Losartan Free Base

Candesartan

0.02 – 2

0.02

0.2 – 20

0.2

0.02

0.03 – 3.33

0.03

0.03*

0.03*

0.03*

0.025 – 2.5

Others

Active Pharmaceutical Ingredients

Nitrosamine

LOQ (ppm)

Method range (ppm)

Ranitidine HCl

Metformin HCl

Other APIs

NDMA

NDEA

NMBA

NEIPA

NDIPA

NEMA

NDPA

NDBA

NDMA

NDEA

NMBA

NDMA

NDEA

NDMA

NDEA

NDMA

NDMA

NDMA

0.2 – 20

0.2

0.02 – 2

0.02

0.2 – 20

0.2

0.02 – 2

0.02

0.075 – 2

0.075

0.03 – 3

0.03 – 3

0.03 – 3

0.2 – 20

0.2

0.02 – 2

0.02

0.2 – 20

0.2

0.2 – 20

validations in progress routinely

0.2

0.02 – 2

* Validation is still running and LOQ will be declared soon

There is a dedicated cross-functional team dedicated to the Nitrosamines project which assures tailoring the project scope to the customer’s needs and secures delivery of the results within the agreed timeframe. Based on the requirement, we provide either indicative screening results or validated GMP results. The standard scope of the validation program is: SST, Selectivity, LOQ, Linearity, Precision and intermediate precision (n=12), Accuracy, Range, Robustness and Stability.

Examples of typical lead times:

  • Development of the custom limit test: 2 weeks
  • Development of the custom quantitative method: 3 weeks
  • cGMP validation of the method for one product incl. reporting: between 2.5 and 4 weeks (depending on number of impurities to be reported)
  • Screening of the sample using already routine method: 5-10 working days with throughput of 50 samples per day
  • Quick pre-screening of the samples using in-house general method: within 2 weeks (number of the impurities to be reported is product specific)

Get in touch with one of our Nitrosamine experts today, or use the contact information for our commercial team below, and see how we can create the perfect solution for you.

Validation and transfer of methods

The introduction of the new analytical method is the most important step in the operation of the analytical laboratory and is therefore closely monitored by the project coordinator and the management of the laboratory. Transferring the method from a company to another lab is also thoroughly controlled and is usually supervised by our experienced analyst on site.

Transmissions and validation of the methods are in accordance with GMP rules and approved protocols. All experiments required for these work are conducted by our experienced analysts and supervised by the project coordinator. The reason is to ensure that the analytical method works accurately and correctly in all workplaces.

Got your own question?

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.

Got your own question?

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.

Got your own question?

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.

Got your own question?

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.

Got your own question?

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.

Got your own question?

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.

Got your own question?

API Sourcing

Nabízíme

Další
služby

a poradenství

  • SVP Balení / Štítkování pro stabilitní studie a klinické testování
  • Audit Modulu 3
  • Kompilace IMPD
  • Monitoring studií

If you don't see what you need or have a question, get in touch with us!

  • Farmakovigilance
  • Regulatorní záležitosti
  • Registrace generik v Rusku
  • A další ....

Pokud nevidíte, co potřebujete, nebo máte otázku, žádný problém.
Náš obchodní tým vám rád pomůže!

Jiří Raška

Chief Commercial Officer

David Dvořák

Business Manager
& Scientific Advisor

Pavel Pihera

Business Manager
& API Sourcing Manager
Contact Us
clients

Testimonials

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Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager
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We're there now! Please visit us at stand 121B56.
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