We completely implement the vision of the paperless laboratory. All processes are only available digitally in our Laboratory Information Management System (LIMS). This is the only way we can guarantee the increasing requirements in terms of data security. As a customer, you benefit from real-time data transmission and are therefore informed about the status of your sample at all times. Your administrative effort is reduced to a minimum.

Our certificates (GMP, FDA) can be downloaded from the following link:

QUALITY Vision

myassay

The product myAssay includes the classic contract analysis. These are analysis methods that are technically carried out within apis Labor GmbH.

Apis Labor GmbH focuses on the following main areas of analysis:

assay

impurity testing

identity testing

myprocess

In addition to the basic analyses, we also offer to take over processes as a whole. We work here with contract laboratories that we have qualified in order to be able to process the processes you require as a whole. The advantage for you as a customer is that you do not have to hire several specialized contract laboratories, but have one central contact person who supplies the entire package.

We offer a one stop shop. You get the solution to your problem, we organize the solution.

iconnect

iConnect is the communication tool for data transmission between the customer and us. With iConnect we are able to transmit data bidirectionally, independent of your existing ERP system. The possibility of directly connecting your ERP/SAP system with the LIMS of apis labor GmbH represents the greatest possible customer benefit and enables error-free online data transmission and thus reduces your administrative effort.

Chemical and physical analyses

titration

Titrations are simple chemical reactions that are recorded by means of a color change or potentiometrically. This is a very stable and exact content determination method for raw materials (usually active ingredients).

UV determination

The identity or the content of a substance is determined by means of the UV determination. In order to determine the content, the substance must be present in its pure form.

Particle size determination (PSD - analytics)

Particle size and particle size distribution (PSA) have a significant impact on the properties of particulate products and can affect their quality, processing, transportation, storage and shelf life. Laser diffraction is a proven and efficient method for determining particle size, the measuring range of which extends from the submicron to the millimeter range. Laser diffraction is a robust measurement technique for powders and suspensions which we can carry out under GMP requirements.

CHNS - Analysis under GMP (Elementary Analysis for Carbon / Nitrogen / Sulfur and Hydrogen)

Elemental analysis for excipients, active ingredients (API) and finished products in the GMP environment. Our in-house validated CHNS method can be used for many different matrix systems.

Reference standard qualification (secondary standard qualification) using CHNS analysis in the GMP area.