Colorants pharmaceutical industry

Analysis and Specifications. Typical product analyses include sohds level, ash, color, conductivity, purity, and minor saccharide levels (19). Specifications for anhydrous and monohydrate crystalline dextrose are available (15). High quahty anhydrous dextrose produced for the pharmaceutical industry is prepared in accordance with additional specifications (20). 

The NF and reagent grades are employed in the pharmaceutical industry which makes use of benzyl alcohol s local anesthetic, antiseptic, and solvent properties (17—20). It also finds use in cough symps and drops ophthalmic solutions bum, dental (21), and insect repeUant solutions and ointments and dermatological aerosol sprays. It is used in nail lacquers and as a color developer in hair dyes by the cosmetics industry (22), and in acne treatment preparations (23). 

The most important UV/VIS applications have been in the fields of color measurement and color matching, areas of great importance to the dye, paint, paper, textile, and printing industries. The pharmaceutical industry has similar interests in that the use of coloring agents in formulations requires specification. Reflectance spectroscopy has been used, however, by a number of workers to study the kinetics and mechanisms associated with a variety of reactions that were found to take place in the solid state. 

In spite of its current popularity in the pharmaceutical industry, the use of two control groups is opposed by some statisticians on the grounds that a significant difference between the two groups may indicate that the study was compromised by excessive, uncontrolled variation. Haseman et al. (1986), however, analyzed tumor incidence data from 18 color additives tested in rats and mice and found that the frequency of significant pairwise differences between the two concurrent control groups did not exceed that which would be expected by chance alone. 

The floor plans of the ABC Pharmaceutical Industries production facility located in (city and country name) are included under (provide reference to attachment no.). The production areas are color coded as to their environmental classification. The site plan highlights the production areas, rooms, and area classifications. The following drawings are included under (provide reference to attachment no.) ... 

Appearance, particularly color, is an important characteristic of a food or a supplement because the first impression is made on that. Thus, natural or synthetic colorants play a vital role in food and pharmaceutical industries. Certain legal aspects related to biological effects, purity of synthetic... 

The pharmaceutical industry makes use of benzyl alcohol s local anesthetic, antiseptic, and solvent properties. It is used in nail lacquers and as a color developer in hair dyes by the cosmetics industry, and in acne treatment preparations. 

The FD C Act divided the synthetic colors into three categories colors for foods, drugs, and cosmetics (FD C), colors for drugs and cosmetics (D C), and colors for externally applied drugs and cosmetics (external D C). All synthetic colorants approved for use today must meet the specifications, uses, and restrictions as described in Title 21 of the CFR (Parts 74, 81, and 82). Certified synthetic colorants are the primary source of colorants used in the pharmaceutical industry. 

Color Additive Petitions are being submitted and reviewed by the FDA for a number of new colors and extended uses of existing colors. During the next several years, it is expected that many of these colorants may be approved for these uses in the U.S. pharmaceutical industry. 

Oil absorption is a measure of the amount of oil necessary to wet out a pigment particle such that each particle becomes enclosed in a shell of oil. The amount of oil required depends on the surface area of the pigment and the porosity of the particle. This property probably has more application in the paint industry than in coloring pharmaceuticals. It may be of some limited value in producing ointments and salves. 

Essential oils boil at elevated temperatures, but many cannot be directly distilled without decomposition. Vacuum, steam, and fractional or molecular distillation are often used for their manufacture. Fractional distillation removes traces of water, resinous materials, colors, terpenes, and sesquiterpenes from the distillate. This process improves solubility and enhances flavor intensity. Sesquiterpeneless oils are more soluble than terpeneless oils because of the removal of head and tail fractions (e.g., waxy residues). Most common sesquiterpeneless oils used in the pharmaceutical industry include oil of orange and oil of lemon. 

The pharmaceutical industry has been required by regulatory authorities to take a strong interest in polymorphism and solvatomorphism once it was realized that the nature of the structure adopted by a given compound upon crystallization would then exert a profound effect on the solid-state properties of that system. For a given material, the heat capacity, conductivity, volume, density, viscosity, surface tension, diffusivity, crystal hardness, crystal shape and color, refractive index, electrolytic conductivity, melting or sublimation properties, latent heat of fusion, heat of solution, solubility, dissolution rate, enthalpy of transitions, phase diagrams, stability, hygroscopicity, and rates of reactions, were all affected by the nature of the crystal structure. 

The sources of lipophilic/hydrophilic chemical exposure include environmental pollution (air, water, and soil contamination), pesticide, herbicide, and fertilizer residues in foods and drinking water, excipients (non-active additives such as colors, flavors, rheological agents, etc,) in foods and pharmaceuticals, industrial chemicals, household chemical products, personal care products, cosmetics, and environmentally synthesized chemicals that are formed from reactions with released chemicals with each other and with naturally present species. 

Lycopene is presently of particular interest for the food and pharmaceutical industries, both as a natural colorant and as a nutraceutical. People knowledge and... 

Fillers are used by the pharmaceutical industry for three main functions as colorants, disintegrants, and glidants. Each application demands special properties, as discussed below. Pharmaceutical grade fillers differ from those used by other industries in that they must comply with a high purity standard. The purity of material for pharmaceutical use is not only defined in terms of chemical composition but microbiological contamination is strictly limited. 

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