UV-Vis spectroscopy is considered the oldest and one of the most essential spectrophotometric methods for analyzing various chemical compounds. The action of this technique is based on the phenomenon of absorption of electromagnetic radiation in the UV/VIS range by the molecules of the analyzed substance. Based on the characteristic signals present in the recorded spectra, we can infer the composition and identity of the analyzed samples.

Nuclear magnetic resonance (NMR) spectroscopy is an advanced analytical technique that provides precise information about the structure of the compounds under study. The method is used to identify atomic nuclei (mainly carbon and hydrogen) and determine their surroundings in a molecule.

Nuclear magnetic resonance spectroscopy is a useful technique in analyzing the structure of organic pharmaceutical substances and dietary supplements. Based on this, it is possible to infer the identity of the analyzed sample with a reference sample. With this method, it is also possible to determine the composition and content of individual components in simple or complex pharmaceutical and supplement premixes. In addition, NMR measurements allow the identification of various additives in samples, that are impossible to detect with less accurate techniques.

Transmission electron microscopy (TEM) and Scanning electron microscopy (SEM) are among microscopic analytical methods. Both techniques use an electron source to obtain images of the studied substances. The electron gun emits a high-voltage beam, which, interacting with the sample, leads to its visualization. TEM and SEM have the advantage of imaging particles of a wide range of sizes (from nanometers to millimeters). With TEM/SEM measurements, it is possible to learn about the morphology and topography of the analyzed particles.

Complexometric titration is a quantitative analytical technique for determining the content of metal cations in a sample. This method uses a reaction (carried out in the presence of a colored indicator) between the metal ion to be determined and an organic ligand with complexing properties.

Titration analysis helps to determine the extent of the reaction of a product containing metal cations such as calcium, magnesium, or zinc. The method is widely used in various industries. In the food industry, complexometry is used, for instance, to detect the presence of additives or metallic impurities. Pharmaceutical companies, conversely, use complexometric titration to determine metal content in medicinal substances. This makes it possible to maintain the high purity and stability of medicines, thus ensuring compliance with regulatory standard

High-performance liquid chromatography (HPLC for short) is one of the types of column chromatography. It is an essential technique used for identifying and quantifying individual organic compounds in analyzed samples. The basis of HPLC is the varying degree of intermolecular interactions between sample components and the column fill. Substances that interact more strongly with the bed will leave the column after a longer time.

HPLC is an advanced chromatographic technique that can separate complex mixtures to identify individual compounds and confirm the identity of the tested mixture against the claimed composition. Due to its considerable specificity and precision, high-performance liquid chromatography is among the main analytical techniques recommended by the Pharmacopoeia for determining drug substance.

Powders’ ability to tableting depends on various properties of the raw material, such as particle size and size distribution, bulk density, and angle of repose. Based on these parameters, we evaluate the suitability of raw materials for use in tablets.

Particle size analysis (granulometry):

Sieve analysis is one of the methods used to evaluate the particle size distribution in powders. The technique involves sifting the powder through a set of sieves of different mesh sizes and collecting fractions of a specific size. By measuring the masses of each fraction, it is possible to determine the percentage content of each size in the total mass of the powder and thus assess its homogeneous properties. As homogeneity decreases, the tendency of powders to stratify into individual fractions increases. Particle size dispersion in powdered raw materials is most often given on the mesh scale.

Bulk density:

The bulk density of powder substances is defined as the ratio of the mass to the volume of a loose powder sample.

The Hausner coefficient is an important parameter related to bulk density, which measures the powder’s ability to settle. It is the ratio of the volume of the uncompacted sample to its final volume after compaction. Measurements of the Hausner coefficient provide information on a powder substance’s susceptibility to compaction. For raw materials with high flowability, the values of bulk density before and after compaction are similar, and the Hausner coefficient is close to 1.

Substances with high bulk density are used as raw materials for tablet preparation, while granules and powders with a lower bulk density are more suitable for capsule applications.

The angle of repose:

Measuring the angle of repose is one way to determine the fluidity of a powder substance. High flowability is an important parameter because it affects the even distribution of the powder substance and makes it easier to work with.

At our facility, we perform comprehensive testing of the properties of finished tablets and capsules. We test parameters such as mass uniformity, hardness, and abrasion resistance. We also analyze the release and disintegration time of tablets.

Hardness measurements provide information about tablets’ resistance to mechanical damage. The tablet’s high hardness may indicate a tendency toward slower dissolution and longer disintegration time in solution. On the other hand, tablets characterized by low hardness tend to crumble and disintegrate quickly under mechanical influence.

Another parameter assessing tablet durability is abrasion resistance. This parameter is measured using a special device called a friabilator. A tablet is considered resistant to abrasion if the loss of its mass is no more than 1%.

Disintegration time analysis with specialized equipment determines whether capsules or tablets introduced into the solution will disintegrate within a specific time.

On the other hand, release studies using pharmacopeia-recommended apparatus allow for an accurate characterization of the active substance’s availability in the tested tablet/capsule.