The Vital Role of Coloring Agents in Pharmaceuticals Explained

Coloring agents, colorants, or color additives refer to any dye, pigment, or substance used to impart colors to food, drugs, and cosmetics. Coloring agents are widely used in various industrial applications, including coloring foods, drugs, and cosmetics. In this blog post, we will talk about coloring agents in pharmaceuticals. 

The use of pharmaceutical coloring agents is widespread and is regulated by the U.S. FDA under certain regulations and stringent quality standards. The FDA regulates the use of coloring agents or color additives to ensure that products containing these dyes are safe to consume, only include approved ingredients, and are labeled accurately.

It’s a common question to ask what pharmaceutical colors are and why they are added to dosage forms. Pharmaceutical colors or coloring agents are dyes or color additives most commonly used to enhance the appearance, increase the palatable value of products, and reduce the chances of drug counterfeiting. 

A lot of pharmaceutical manufacturers today rely on color additives for coloring tablets, capsules, syrups, and medical devices. Are you still wondering why use colors for pharmaceutical products and what benefits they provide to your business, you have landed in the right place. 

Here we will walk you through the use of coloring agents in pharmaceuticals.

What is a coloring agent?

A coloring agent or colorant is a substance used to impart color to a certain product or material. Coloring agents are most commonly used in food, drugs, cosmetics, and other pharmaceutical products.

These coloring agents are further classified as dyes and pigments on the basis of how their solubility in water and different coloring mediums. 

1. Dyes

Dyes are organic substances that can be dissolved in solutions and provide more vibrant, bright colors.

2. Pigments

Pigments are insoluble fine powders used to absorb and reflect specific light to create colors.

Determination of colorants in pharmaceuticals

Pharmaceutical analysis requires reliable methods, but these are not given sufficient attention in general. The following are the main pharmaceuticals that are colored, including but not limited to: 

• Tablets: Either the coating or the core itself.
• Hard or soft gelatine capsules: the coated beads or capsule shell.
• Topical ointments and creams.
• Oral liquids.

These different dosage forms are therefore processed using conventional sample processing techniques. 

Furthermore, it is possible to prepare a sample in several ways, including dispersion, particle size reduction (such as milling, grinding, and homogenizing), solubilization of the target to be examined, derivatization, cleanup (for example, removing undesirable interferences) and clarification (for example, removing insoluble materials).

Why coloring agents are added to pharmaceuticals?

The use of coloring agents in pharmaceuticals is globally popular as they help manufacturers identify different dosage forms during manufacturing and distribution. There are many reasons why coloring agents are used in pharmaceuticals: to improve visual appearance, increase palatable value, drug identification, enhance dosage forms, and reduce drug counterfeitings. 

For businesses, it’s impossible to ignore the importance of pharmaceutical colors in tablet coating due to their extensive properties and capabilities to add significant value to products. The use of coloring agents in pharmaceuticals is globally accepted in various applications, including tablet colorations, capsule colorations, syrup coloration, and various other pharmaceutical dosage forms.

However, these coloring agents or pharmaceutical colors are regulated & governed by the U.S. FDA to ensure the safety of patients. 

Use of FD&C and D&C colors or coloring agents in pharmaceuticals

It is almost unique for dyes or colorants to hold such a high status as pharmaceutical excipients, inspiring most regulatory agencies around the world to maintain lists of certified synthetic colors allowed in medicinal products. The purity of the individual colors or coloring agents used in pharmaceuticals is defined by different rules & legislations.

Globally, many regions distinguish between the colors that are used for drug packaging & food packaging. As per the Food Drug and Cosmetic Act of 1938, three categories of coal tar dyes were created, of which only the first two apply to the manufacture of chewable tablets.

1. FD&C colors 

FD&C colors are synthetic food colors or colorings certified and approved by the U.S. FDA for use in different industrial applications, including, pharmaceuticals, food, and cosmetics. These are colorants that are certifiable for use in foods, drugs, and cosmetics.

• FD & C Yellow No. 5: Tartrazine ( provides lemon yellow shade)
• FD & C Yellow No. 6: Sunset Yellow (gives orange shade)
• FD & C Blue No. 1: Brilliant Blue FCF (offers bright blue shade)
• FD & C Blue No. 2: Indigotine (offers royal blue shade)
• FD & C Red No. 3: Erythrosine (provides cherry red blue shade)
• FD & C Red No. 40: Allura Red (imparts orange-red shade)

2. D&C colors

D&C colors, also known as drug and cosmetic colors are best suitable for hard & soft gelatin capsules, tablet coatings, compressed tablets, syrups, toiletries, skin-care products, pencils, water-based make-up, foundation, lip gloss, lipstick, and nail polish. 

D&C colors refer to dyes and pigments that are safe to be used on drugs, cosmetics, and HI & I applications. The following are some of the most popular D&C colors widely used in drugs and cosmetics:

• Acid Red 92 -PHLOXINE B (NA SALT): D&C Red 28 – 45410
• Acid Red 87 -EOSINE (NA SALT): D&C Red 22- 45380
• Solvent Violet 13: D&C Violet 2 – 60725
• Acid Violet 43: D&C Ext. Violet 2 – 60730
• ACID GREEN 25: D&C Green 5 – 61570
• Solvent Green 3: D&C Green 6 – 61565
• Solvent Green 7: D&C Green 8 – 59040
• Acid Yellow 3: D&C Yellow 10 – 47005
• Acid Yellow 73: D&C Yellow 8 – 45350
• Acid Orange 7: D&C Orange 4 – 15510
• Acid Red 33: D&C Red 33 – 17200

3. External D&C colors

Ext D&C colors are synthetic dyes that are certified batches and only approved for use in drugs and cosmetics to be applied externally. Colorants in this category are not deemed safe for ingestion due to their oral toxicity, so they are not certified for use in cosmetics or household products, but for external use only with limited applications.

External D&C Violet No. 2: Acid Violet 43 – 60730 is an example of Ext D&C colors. 

There are many types of pharmaceutical colorants, and according to the manufacturer’s data sheets, it is necessary to consult on safety and handling data for certain colors. Furthermore, manufacturers need to keep up with the safety and compliance of pharmaceutical colorants. 

Regardless of the complexity of the process or the quantity of materials being handled, standard chemical handling precautions should be taken. It is generally considered that pharmaceutical colorants and pigments and lakes do not pose a significant threat to human health.

In addition to adhering to FDA good manufacturing practices (cGMPs) applicable to drugs, food, and cosmetics, it is also imperative to ensure that the products are safe and high-quality.

Conclusion

Coloring agents in pharmaceuticals play a vital role in improving the visual appearance of pharmaceutical products, enhancing palatable value, identifying different dosage forms, and reducing drug counterfeitings like never before. Hence, the importance of colors or coloring agents in the pharma industry can’t be overlooked as they are the main things that add greater value to pharmaceutical products. 

Pharmaceutical manufacturers are advised to use superior-quality synthetic dyes and pigments from well-known manufacturers and exporters like Hridhan Chem. Hridhan Chem is a leading manufacturer and supplier of the finest quality synthetic dyes and pigments and offers a comprehensive range of colors, including food colors, cosmetic colors, and pharmaceutical colors for a variety of industrial applications. 

Need more information on a wide range of coloring agents or different types of synthetic dyes and pigments we produce at our manufacturing facility, get in touch with us today.