Laboratory

Infrared spectroscopy (IR) is a research technique that uses infrared radiation to interact with matter. This interaction provides us with information about the composition and structure of chemical compounds. By studying the interaction between IR rays and the sample, we can identify individual components in the analyzed samples and confirm the identity of the compounds.

IR spectroscopy is recommended by the Pharmacopoeia, along with chromatographic methods, for the identification of chemical substances. Therefore, it is widely used in the pharmaceutical and supplement industries. The use of this technique allows for the identification of substances or confirmation of the identity of product ingredients.

UV-Vis spectroscopy is one of the oldest and most important spectrophotometric methods used to analyze chemical compounds. This technique operates by measuring the absorption of electromagnetic radiation in the UV/VIS range by the molecules of the substance being tested. By examining the characteristic signals present in the recorded spectra, we can determine the composition and identity of the analyzed samples.

Nuclear Magnetic Resonance (NMR) spectroscopy is an advanced analytical technique used to determine the structure of compounds by identifying atomic nuclei, mainly carbon and hydrogen, and determining their surroundings in the molecule. This method is highly valuable in analyzing the structure of organic pharmaceutical substances and dietary supplements. NMR measurements allow for the identification of various additives in samples that are impossible to detect using less accurate techniques. Additionally, it is possible to conclude the identity of the analyzed sample with the reference sample and determine the composition and content of individual ingredients in simple or complex pharmaceutical and supplement premixes.

Transmission electron microscopy (TEM) and scanning electron microscopy (SEM) are both microscopic analytical methods that use an electron source to obtain images of substances being examined. The electron gun emits a high-voltage beam that interacts with the sample to visualize it. One of the main advantages of using TEM and SEM is that they allow for imaging of particles across a wide range of sizes, from nanometers to several millimeters. Thanks to TEM/SEM measurements, it is possible to learn about the morphology and topography of the particles being tested.

Complexometric titration is a quantitative analytical technique used to determine the amount of metal cations present in a given sample. This method involves a reaction between the metal ion being analyzed and an organic ligand that has complexing properties, with a color indicator present. The titration analysis helps to determine the extent of reaction of a product containing metal cations such as calcium, magnesium or zinc. This method is widely used in various industries; for instance, in the food industry, complexometry is used to detect the presence of metallic impurities or additives. Similarly, pharmaceutical companies use complexometric titration to determine the metal content of medicinal substances, ensuring high purity and stability of the products, and compliance with regulatory standards.

High-performance liquid chromatography (HPLC for short) is one of the types of column chromatography and is an extremely important technique used both for the identification and quantitative determination of individual organic compounds in the analyzed samples. The basis of HPLC is the different degree of intermolecular interactions between the sample components and the column filling (bed). Substances that interact more strongly with the bed will leave the column after a longer time.HPLC, as an advanced chromatographic technique, can be used to separate complex mixtures to identify individual compounds and confirm the identity of the tested mixture in relation to the declared composition. Due to its significant specificity and precision, high-performance liquid chromatography is one of the main analytical techniques recommended by the Pharmacopoeia for the determination of drug substances.

Testing the tableting ability of powdered raw materials is dependent on their various properties such as the size and distribution of particles, bulk density, and angle of repose. These parameters are used to evaluate the suitability of the raw materials for tablet production.

Particle size analysis (granulometry)

Particle size analysis, also known as granulometry, is the process of assessing the distribution of particle sizes in powders. One of the methods used for this analysis is sieve analysis, which involves sifting the powder through a set of sieves with varying mesh sizes, and collecting fractions of a certain size. By measuring the masses of each fraction, we can determine the percentage content of each size in the total mass of the powder, and thus assess its homogeneity. As the homogeneity of powders decreases, the likelihood of separation into individual fractions increases. The particle size distribution of powdered raw materials is often given on a mesh scale.

Bulk density

Bulk density is a measure of the mass per unit volume of a loosely poured powder sample. The Hausner coefficient is a parameter related to bulk density that measures a powder’s ability to settle. It is the ratio of the volume of the uncompacted sample to its final volume after compaction. The Hausner coefficient gives us an idea of how easily the powder substance can be compacted. If the raw material has high flowability, then its bulk density before and after compaction will be similar, and the Hausner coefficient will be close to 1. Substances with high bulk density are used as raw materials for tablet preparation, while granules and powders with lower bulk density are more suitable for capsule applications.

Angle of repose:

The angle of repose is a method to measure the fluidity of powdery substances. It is an essential parameter as it determines the ease of working with raw materials during pouring and distribution. High flowability ensures even distribution of the powder substance and makes it easier to work with.

At our facility, we conduct thorough assessments of the properties of tablets and capsules. The testing encompasses parameters such as mass uniformity, hardness, and abrasion resistance. We also analyze the release and disintegration time of tablets.

Hardness measurements offer insights into the resistance of tablets to damage from mechanical forces. High hardness may indicate slow dissolution and longer disintegration in solution, while low hardness may lead to crumbling and disintegration under mechanical stress.

Abrasion resistance is another parameter that we measure using a specialized device called a priabilator. This helps determine the durability of tablets.

Disintegration time analysis is performed using specialized devices to assess whether the capsules or tablets introduced into the solution will disintegrate within a specific time.

Finally, release testing using equipment recommended by the pharmacopoeia provides precise information about the availability of the active substance contained in the tested tablet/capsule.