The requirements for products manufactured by pharmaceutical concerns makes it necessary to use raw materials and additives of the highest quality and purity. These substances must meet many restrictions described in European Pharmacopoeia. They concern not only acceptable ranges of different parameters, but also test methods. The high quality of pharmaceutical products offered by the PCC Group allows to meet these requirements. The company’s offer is still expanding with new products, and their quality and safety is ensured by a number of implemented standards e.g., GMP, ISO 9001, ISO 14001 or OHSAS.
The PCC Group is an international producer of almost 1000 chemical products targeted in various sectors of industry. Its structure comprises a group of companies (including PCC EXOL, PCC Rokita) specialising in the production of various types of product groups. One of the main areas of development of the PCC Group’s product portfolio is the launch of product range for the pharmaceutical industry.
The development of product range for the pharmaceutical industry has its origins in PCC EXOL SA. In 2016, the first product of pharmaceutical quality was developed and implemented for sale – POLIkol 600PF. It belongs to the group of polyoxyethylene glycols (PEG) and fully meets the requirements described in the European Pharmacopoeia monograph for Macrogol 600. High product quality is ensured thanks to manufacturing in production plants covered by GMP certification. This ensures that the product meets stringent quality parameters for very low levels of toxic contaminants, such as ethylene oxide, dioxane, formaldehyde and mono- and diethylene glycol.
The development and implementation of the first pharmaceutical quality product for sale was a milestone for the development of the portfolio of PCC EXOL and the entire PCC Group. Since then, the offer has been enriched with further products belonging to the group of excipients that meet the stringent pharmacopoeial requirements. Pharmaceutical grade products are manufactured on plants covered by GMP standards, which ensures the appropriate quality and safety of raw materials offered for pharmaceutical applications. PCC EXOL SA can boast of such flagship products as macrogols with a molecular weight of 400, 600, 1500, 3350 and 6000.
Recently, the product range from companies belonging to the PCC Group has been enhanced with further pharmaceutical quality products. To meet the needs of its customers, the R&D Department of PCC EXOL has developed ROKAcet HR40PF (ethoxylated hydrogenated castor oil). The physicochemical parameters of this product are consistent with the requirements published by the European Pharmacopoeia in the monograph for Macrogolglycerol Hydroxystearate. ROKAcet HR40PF is a widely-used component of formulations intended for applying directly to the skin (ointments, creams, gels). The product also works well in an oral application in the form of tablets, capsules and even dental solutions due to the lack of taste and a very weak, almost imperceptible odour. Another novelty in the range is a product from the group of ethoxylated castor oils named ROKAcet R36PF. It is the equivalent of Macrogol Glycerol Ricinoleate.
The offer dedicated to the pharmaceutical industry also includes sodium hydroxide in solid form i.e. caustic soda (read more about sodium hydroxide suppliers). In the PCC Group this substance is produced by membrane electrolysis, which ensures its high quality and purity. As a result, the offered product meets the requirements of the latest edition of the European Pharmacopoeia. Pharmaceutical caustic soda is characterised by low chlorides and iron content, and production technology allows to meet Kosher requirements.
Another of the inorganic compounds for the pharmaceutical industry is hydrochloric acid in the form of 37-38% solution. The production method used in the synthesis installation i.e., the direct reaction of chlorine combustion in hydrogen, ensures low content of impurities. As a result, the product is dedicated, amongst other things, to pharmaceutical application, and the technical specification reflects Monographs for hydrochloric acid.
The high quality of raw materials used in the pharmaceutical industry is required not only at the stage of creating the final formulation. An appropriately high purity, confirmed by tests, must also be maintained for substances used for the synthesis of active substances (Active Pharmaceutical Ingredient – API). Among the substances manufactured by the PCC Group, such products as phosphorus trichloride, phosphorus oxychloride and monochlorobenzene are dedicated to this application.
Phosphorus trichloride and phosphorus oxychloride are used as substrates for the synthesis of phosphorus and chlorine chemical compounds due to the high reactivity of phosphor-chlorine bonds in their structure. These substances are involved in the synthesis of drugs based on sulphonamide derivatives and bisphosphonates, as well as B group vitamins. The production technology of these compounds in the PCC Group allows to obtain final products of a very high purity. They are characterised by low content of elemental sulphur and heavy metals.
The company’s offer includes monochlorobenzene. This is a substrate in the synthesis of, among others, paracetamol (para-aminoacetylphenol) and vitamin B6. It is also used in the synthesis of drugs for epilepsy, thyroid cancer and liver cancer. This substance is also used for the production of zoledronic acid, used as a drug in the treatment of osteoporosis, and chlorphenoxamine, which has anti-allergy and anti-ageing effects.
Macrogols, sodium hydroxide and hydrochloric acid (read also about hydrochloric acid for food industry) are just some of the pharmaceutical quality proposals in the PCC Group’s product range. The high purity of the products and their compliance with the requirements of the European Pharmacopoeia makes the company a trusted manufacturer in the pharmaceutical industry for producers seeking raw materials and additives of the highest quality. The dynamic work of R&D departments of companies as well as market requirements gives direction to the product portfolio of this industry for new products. This gives the PCC Group a chance to achieve a strong position among the producers of chemicals for the pharmaceutical industry.