Pharmaceutical Product

Pharmaceutical products must be tested for their quality, safety, and efficacy. To ensure product conformity with international standards such as Ph. Eur. and USP, various physicochemical and biological tests are performed.

Physicochemical Tests

• Identity Tests: Various identity tests, including physical and chemical methods, are performed to confirm the identity of a drug or product. These approaches include spectroscopy, chromatography, and reactions. [3, 85, 130] Tocopheryl acetate, Hydroxypropyl cyclodextrin, particle size 58 TPGS and HPBCD, 2-HPBCD Guo et al. Eur.) and USP monographs.

• Purity Test: Undesirable impurities in drugs or formulations (e.g., solvent residues, reaction residues, degradation products) can be determined by limit tests or quantitative analytical procedures. These tests are performed according to the relevant pharmacopoeias.

• Water Content Determination:The water content in both formulations and pure active pharmaceutical ingredients is typically measured using sensitive methods such as Karl Fischer titration.

• Sterility Test:To ensure that a sterile pharmaceutical product (e.g., injectable solutions, ophthalmic preparations) is not microbiologically contaminated, a sterility test is performed.

• Bacterial Endotoxin Test: For injectable drugs and other medical substances, tests are performed to detect pyrogenic or bacterial endotoxins, which can cause fever in the body.

In-vivo Tests

• Safety Pharmacology Studies:The potential adverse effects of a drug candidate on physiological systems (cardiovascular system, respiratory system, and central nervous system) are investigated according to ICH Guidelines S7A and S7B.

• Acute Toxicity Tests:Toxic effects occurring shortly after exposure to a single dose of the test chemical are determined. These tests are conducted according to OECD Test Guidelines 420, 423 (oral administration), 402 (dermal application), and 403 (inhalation).

• Repeated-Dose Toxicity Tests:Target organ toxicity throughout the organism is determined after repeated administration of the drug over various periods and at different dosages (e.g., 28 or 90 days). These tests are conducted according to OECD Guidelines 407, 408, 410, 409, and 411.

• Genotoxicity Tests:These tests assess whether drugs damage DNA or chromosomal structure. They include in vitro and in vivo tests. The main tests are:

• OECD TG 474: Demonstrates genetic damage through the formation of micronuclei in erythrocytes.
• OECD TG 475: A bone marrow chromosomal analysis is performed to detect structural chromosomal aberrations. These studies are conducted according to ICH S2 guidelines.

• Reproductive and Developmental Toxicity Tests:Assessment of the effects of drugs on reproduction and development (including fertility and the ability to carry a pregnancy to term, until the offspring reach adulthood). The following tests are performed:

• OECD TG 414: These include studies investigating effects on prenatal development and pregnancy.
• OECD TG 415: A one-generation assessment of reproductive performance and offspring development is conducted.
• OECD TG 416: Two-generation study providing comprehensive data on reproductive toxicity. These studies are conducted according to ICH S5.

• Local Tolerance Studies:Studies to determine the drug's potential to induce local reactions at the application site (e.g., injection site, skin).