Growth of health services and pharmaceutical industry depends on the availability of qualified manpower, suitable infrastructure, right machinery and availability of high purity chemicals. These high purity chemicals are used in clinical laboratories, manufacturing and testing of pharmaceutical materials, biopharmaceutical research and development, food and cosmetic industries. One of the major factors responsible for innovation and productivity in pharmaceutical industry is the constant availability of high purity chemicals such as high purity excipients, biochemicals, analytical reagents and microbiology culture media etc .
Over the last 50 years, number of Indian companies have made an effort to develop suitable range of chemicals for analysis of pharmaceutical, food, cosmetic raw material, in process and finished products . In 1960-80 one of the prime reasons of high cost of R&D expenses and delay in innovation was non availability of high purity chemicals. Indian scientists were putting sizable time in purification and synthesis of chemicals as per their standards before using them in their applications. This method of research was not effective and time consuming. One option was to import chemicals which suit to their requirement but that made the R&D projects expensive and delay in delivery and received material was not as per the agreed standards.
High purity fine chemicals are used in for various applications from pharmaceutical to space science, educational institutes, drug research and development. Quality of products or group of products in fine chemicals industry is defined by various parameters, pertaining purity and impurities with grade and application of the products. With advancement in analytical instruments, detection of impurities in ppb level in pharmaceutical and food products’ analysis and stringent legal requirement pertaining to the product purity and impurities has become possible. Various parameters like heavy metals, residual solvents etc registered the attention from drug and chemicals manufacturers. This market condition created requirement of various grades of chemicals in analysis and manufacturing of drugs.
Number of domestic and international manufacturers identified this opportunity and developed necessary manufacturing processes and started research and development activities. These high purity fine chemicals are used as laboratory chemicals in chemical analysis from wet analysis to instrumental analysis, new chemical synthesis, purification of active compounds and as raw materials in manufacturing of API, speciality chemicals and so on. To develop uniformity in specification and method of analysis , some professional organisations like American Chemical Society (ACS) and Food Chemical Codex have published standards which are followed globally.
The Food Chemical Codex (FCC) is a compendium of standards that establishes specifications of quality, purity and identify and support validated testing procedures for several food ingredients. With growth in pharmaceutical industry and specific demand for new chemicals for research, chemical manufacturers offered products as per customer specifications and regular use of same specifications by new customers created new grade specifications and later on the same specifications and grades became benchmarks for the industry. To set standards in chemical quality, specification and method of analysis, Bureau of Indian Standard (BIS) published specifications of chemicals used in water, food analysis and various other industries.
Specifications of chemicals which are used as excipients in drug formulation and Active Pharmaceutical Ingredient (API) are well defined in various pharmacopeia. The manufacturers of such chemicals and users follow these standards in their manufacturing operations. Time to time these specification change as per regulatory requirements and application of products. Some manufacturers offer products which meet specification of more than one pharmacopeia and classify them as multicompendial grade chemicals.
Some of the preferred high purity chemicals which are used in drug analysis are HPLC solvents & salts, buffer salts, acids, gradient HPLC solvents, LC-MS solvents, GC-HS grade solvents and Pesticide residue grade solvents as well. Preferred method of analysis in pharmaceutical industry for purity and impurities is the HPLC method. To have consistent and accurate result, HPLC solvents play very vital role and impurities present in these solvents impact the accuracy of the analysis. To address high end analysis through LC-MS, solvents are specially purified and analysed to suit such type of application.
Some of the recently introduced solvents like GC HS grade are suitable for analysis of residual solvents present in the drugs. High purity mineral acids which are free from metallic impurities are used for monitoring heavy metals in API, drug formulation, food and beverages upto ppb levels. With the use of pesticides in agriculture products, potable water and soil get contaminated, concentration of pesticides are found more than desire levels and this has become a concern for health and environment as well. Regular monitoring of agriculture products for pesticide content conform suitability for human consumption. Pesticide residue grade solvents are used to monitor pesticides by GC with ECD detector in agriculture products and soil.
The growth of high purity fine chemicals industry depends upon the growth of pharmaceutical , biopharmaceutical , chemical , food and beverage industry and research and development investment in private sector and government sponsored projects. Currently 0.25 per cent of India’s GDP is spent on research and development. The government proposes to step this up to two per cent of GDP with half of that amount coming from private industry and other half from the public sector companies.
To address growing need of high purity fine chemicals in domestic and international markets for drug formulation , chemicals analysis of raw material and finished products in pharmaceutical industry, Finar Limited has a state of the art manufacturing plant near Ahmedabad for solvent purification and manufacturing of organic and inorganic salts. The company has a nation-wide distribution network and a strong sales team supported by a qualified technical services department. Finar aims to focus on delivering high quality products at an economical cost with shortest delivery times.
(The author is General Manager–Operations, Finar Ltd)