The quality of chemical raw materials is an important factor in pharmaceutical production

Published: 2-08-2017

The pharmaceutical industry stands out among other areas of the chemical industry with high growth dynamics as well as above average profitability. It is, at the same time, one of the most innovative industries, investing significant financial resources in research and development. The development of medicine, demographic changes associated with ageing and increased health consciousness have greatly increased the demand for medicinal products. Another important factor influencing the pharmaceutical market is the regulatory environment. The change of the availability status of certain medicines from Rx, that is, prescription, to OTC (over-the-counter products) is also important.

The main ingredient of most medicinal products available on the market is known as API (Active Pharmaceutical Ingredient). These are active pharmaceutical substances, otherwise known as active substances, responsible for the therapeutic effects of medicines. Due to the huge number of known active substances, there exist many pathways for the synthesis of these compounds. A variety of raw materials and auxiliary substances are used for these syntheses. Regardless of the function, all raw materials must meet very high quality requirements determined by the Pharmacopoeia. As defined, the Pharmacopoeia is an official drug list, which contains the applicable standards for their composition, dosage, preparation and storage, and methods of quality testing. The Pharmacopoeia determines which medicines are allowed to be marketed in a given country or territory. It also contains a list of raw materials that can be used to prepare prescription drugs, i.e. hand-prepared directly in a pharmacy, according to medical prescription.

One of the basic substances with a very broad spectrum of uses in the manufacture of medicines is sodium hydroxide. Its contribution is, inter alia, common salicylic acid, i.e. a component of preparations with analgesic, anti-inflammatory and antipyretic activity. Sodium hydroxide is also used in antiseptic activities in dentistry. This compound, when combined with sodium hypochlorite, creates so called Antiformin, i.e. alkaline solution of hypochlorite. Antiformin has a strong disinfectant effect and is used to flush dentinal tubules during dental procedures. Caustic soda offered by the PCC Group meets the high quality requirements set by the European Pharmacopoeia. This makes the use of this product possible in the pharmaceutical industry.

Other compounds used in the manufacture of drugs are chlorinated derivatives of benzene. This group includes monochlorobenzene (MCB) and orthodichlorobenzene (ODCB). They participate in the synthesis of acetaminophen, which is used as an analgesic and antipyretic drug. 3,4-diphenylamine, a transition product in the synthesis of paracetamol (otherwise – N-acetyl-para-aminophenol), is also obtained with the use of chlorobenzenes. In addition, these compounds are used to produce zoledronic acid. This is a widely used medicine in the treatment of osteoporosis of postmenopausal women, as well as in the treatment of cancerous lesions in bone tissue. Its function is to inhibit the processes leading to the weakening of the bone structure, which reduces the risk of fractures and alleviates pain. These compounds are also used in producing chlorphenoxamine, a component of antiallergic drugs.

Inorganic acids, including hydrochloric acid, are another group of compounds which have a wide range of applications in the pharmaceutical industry. The PCC Group is a manufacturer of ultra pure hydrochloric acid of pharmaceutical grade (min. concentration 37%), as well as food grade (min. concentration 33%). This compound acts as a reducing agent in the production of ascorbic acid (commonly known as vitamin C). Hydrochloric acid is also a reducer in the reaction of the synthesis of para-aminobenzoic acid, otherwise known as vitamin B10. The basic use of hydrochloric acid in the pharmaceutical industry is catalysis in the synthesis of active substances, pH control and water deionization.

The development of medicine and the growing demand for medicinal products make a list of known active substances enriched by successive positions each year. At the same time, the demands of patients are growing. Therefore, one of the priorities for any pharmaceutical manufacturer should be ensuring the highest quality of manufactured medicines and the safety of their users. The prudent choice of chemical raw materials and materials applied in the course of production is one of the ways on the road to the achievement of this aim.

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