CALCIUM PANTOTHENATE, CALCIUM CHLORIDE DOUBLE SALT

CAS: 6363-38-8 NUTRIENT SUPPLEMENT

Calcium pantothenate calcium chloride double salt is a nutrient supplement food additive permitted in the United States under specified regulatory conditions.

What It Is

Calcium pantothenate calcium chloride double salt is a defined chemical additive that functions primarily as a nutrient supplement in certain food products. It consists of a complex between calcium pantothenate, a calcium salt of pantothenic acid (vitamin B5), and calcium chloride in approximately equimolar proportion. The CALCIUM PANTOTHENATE, CALCIUM CHLORIDE DOUBLE SALT additive is recognized by regulatory inventories with the CAS number 6363-38-8. As a nutrient supplement, it supplies a source of pantothenic acid, one of the essential water-soluble vitamins required for metabolic processes in humans. The additive may appear under various other names that reflect its chemical composition and formation, such as beta-alanine, N-(2,4-dihydroxy-3,3-dimethyl-1-oxobutyl)-, calcium salt (2:1) compounded with calcium chloride, and calcium pantothenate-calcium chloride complex. Regulatory listings use these synonymic identifiers to support ingredient labeling and compliance. This nutritional additive is classified within the broader category of vitamins and their mineral salts used in food formulation to enhance nutritive value. Pantothenic acid, from which it is derived, forms a component of coenzyme A, an important cofactor in energy metabolism, fatty acid synthesis, and other biologically essential pathways, though specific physiological effects are outside the scope of regulatory description and require authoritative sources. In regulatory contexts, the term "nutrient supplement" denotes an ingredient added to augment or restore nutrients in foods, especially in products designed for special dietary uses. Calcium pantothenate calcium chloride double salt is included in the list of permitted nutrient supplements under United States food additive regulations when used in accordance with good manufacturing practices and prescribed labeling requirements. The chemical form and nomenclature of the additive have been codified in Title 21 of the Code of Federal Regulations, providing clear identity criteria for manufacturers and regulators to reference. While a nutrient source, the additive is not assigned a distinct INS (International Numbering System) designation widely used in global food additive regulation outside of specialized contexts. Its regulatory presence is defined largely through national regulatory frameworks rather than broad international labeling codes.

How It Is Made

The production of calcium pantothenate calcium chloride double salt involves creating a stable chemical complex between calcium pantothenate and calcium chloride. Calcium pantothenate itself is synthesized chemically from pantothenic acid, the calcium salt of pantothenic acid, by reacting pantothenic acid with calcium sources to form the calcium salt. In manufacturing settings, the pantothenic acid component may be prepared synthetically via organic chemical processes that yield stable calcium pantothenate, which is then reacted with a source of calcium chloride to form the double salt complex under controlled conditions. This double salt formation typically occurs in aqueous media where calcium pantothenate and calcium chloride are combined in proportions that favor complexation. The resulting product is isolated and purified to meet food additive specifications that define identity, purity, and composition criteria. Good manufacturing practices guide the process to ensure removal of unreacted reagents, control of moisture content, and maintenance of physical quality attributes such as particle size and flow characteristics. The additive’s properties, such as free-flowing powder and water solubility, are outcomes of both the controlled synthesis and purification processes. Ingredient specifications are often aligned with monographs provided by recognized pharmacopeias or food chemical codices when available. For example, the Food Chemicals Codex (FCC) provides detailed compendial descriptions for many such nutrient additives, outlining identity criteria and analytical methods necessary to confirm the additive meets required standards for use in foods. Manufacturers producing calcium pantothenate calcium chloride double salt for food use must ensure consistency with these quality references and with applicable regulatory requirements. Quality control testing typically includes assays for pantothenic acid content, moisture, and absence of undesirable impurities to support safe incorporation into food products. These industrial practices ensure the additive delivers its intended nutrient function while maintaining defined safety and quality profiles.

Why It Is Used In Food

Calcium pantothenate calcium chloride double salt is used in food products primarily for its role as a nutrient supplement, specifically as a source of pantothenic acid (vitamin B5). Nutrient supplements are incorporated into foods to enrich or fortify products where a specific nutrient may be limited or lost during processing, or to support dietary needs in special formulations. This additive fulfills the technological need to provide a stable, identifiable, and regulated source of a vitamin that plays a role in human metabolism. Regulatory frameworks permit its use under defined conditions to ensure it contributes nutrient value without presenting undue risk when employed in food formulation. Its inclusion in nutrition-focused products is guided by the principle of achieving adequate dietary levels of essential nutrients, particularly in foods designed for special dietary uses, such as medical nutrition or fortified products targeted at populations with specific nutrient needs. Manufacturers often select complexed mineral or vitamin salts, such as this double salt form, because they can offer improved stability and handling characteristics compared to the free acid form of the vitamin alone. In addition, the use of a calcium salt can facilitate integration into formulations that require compatibility with other ingredients, control of solubility, and minimized impact on the sensory profile of the food. The nutrient supplement function also aligns with labeling claims related to vitamin content, where regulations specify the permitted terminology and conditions under which nutrient sources may be declared. Calcium pantothenate calcium chloride double salt thus performs a dual role: meeting regulatory definitions of a nutrient supplement and serving formulation needs for stable, bioavailable vitamin ingredients in finished foods. In practical food applications, this additive is typically chosen when pantothenic acid enrichment is desirable in specialized nutrition products or fortified food matrices. It may be selected over other vitamin forms when a manufacturer seeks to comply with specific nutrient content directives while maintaining the physical and chemical properties suitable for the production process. Its regulatory listing under Title 21 CFR 172.330 reflects an established acceptance of its utility as a nutrient supplement under specified conditions, which supports predictable use in compliant products.

Adi Example Calculation

An illustrative example of how an ADI is used in safety assessment generally involves multiplying a hypothetical ADI value by body weight to estimate a daily intake threshold. For example, if a hypothetical ADI of X mg/kg body weight were established for a nutrient supplement, a person weighing 60 kg would have an intake threshold of 60 times X mg per day. This calculation is illustrative and not specific to calcium pantothenate calcium chloride double salt because a numeric ADI for this compound has not been verified from authoritative sources. The purpose of such examples is to demonstrate how ADI values, when available, relate to body weight and daily intake, and should not be construed as personal consumption guidance. Regulatory frameworks use ADI calculations to inform permissible levels of additives in foods across different categories, ensuring that total intake from all sources remains within safety bounds. In the context of nutrient supplements, formulation decisions consider recommended nutrient intake levels established by nutrition science bodies to support dietary adequacy rather than ADI thresholds alone. Because pantothenic acid is essential and generally well tolerated when consumed as part of a balanced diet, fortification strategies aim to complement nutrient intakes without exceeding established safe levels for the vitamin and its salts.

Safety And Health Research

The safety assessment of calcium pantothenate calcium chloride double salt as a food additive centers on its role as a source of pantothenic acid, a nutrient that participates in normal metabolic processes. Regulatory evaluations, such as the listing in 21 CFR 172.330, indicate a determination that the additive may be used safely in foods for special dietary uses when employed in accordance with good manufacturing practices and prescribed conditions, including appropriate labeling of the additive container with its chemical name and concentration expressed as pantothenic acid. This regulatory acceptance suggests that the FDA has reviewed available data relevant to safety and technical function for its intended use in food. At the international level, expert committees such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluate food additives for safety, develop specifications for identity and purity, and provide toxicological assessments when data permit. JECFA maintains searchable databases of food additive specifications and evaluations; however, specific numeric safety endpoints such as acceptable daily intake (ADI) values or detailed toxicological data for this particular compound are not explicitly provided in the sources d here. In the absence of a clearly identified JECFA evaluation that includes numeric safety thresholds or exposure guidance, it is not possible to assign specific ADI values or definitive global safety conclusions for calcium pantothenate calcium chloride double salt. Scientific research relevant to pantothenic acid and its salts generally encompasses the biological roles of pantothenic acid in metabolic pathways, coenzyme A synthesis, and nutrient requirements. Pantothenic acid is recognized as an essential vitamin, and deficiency states are documented in clinical literature for diets lacking sufficient levels of this nutrient. However, specific health effect studies focused on the double salt form as used in fortified foods are not detailed in the regulatory sources consulted. Therefore, safety considerations remain rooted in its identity as a nutrient supplement and the regulatory determinations that permit its use under defined conditions, rather than specific toxicological endpoints available from international expert bodies like JECFA.

Regulatory Status Worldwide

In the United States, calcium pantothenate calcium chloride double salt is explicitly listed in Title 21 of the Code of Federal Regulations under 21 CFR 172.330, which permits its use as a food additive for direct addition to foods for special dietary uses in accordance with good manufacturing practices and prescribed conditions. The regulation outlines requirements for the form of the additive and labeling of the additive container, ensuring that manufacturers provide the appropriate chemical name and concentration expressed as pantothenic acid. This regulatory listing reflects an established approval for use within defined parameters in the U.S. food supply and indicates that the ingredient is reviewed within the food additive petition process of the Food and Drug Administration (FDA). The presence of this specific section in CFR demonstrates that the additive’s use is subject to regulatory oversight to support safe application in food formulations. At the international level, the additive’s status may vary depending on country-specific food additive regulations. Some jurisdictions align with Codex Alimentarius standards or maintain their own positive lists of permitted nutrient supplements where calcium pantothenate derivatives may be included. International numbering systems such as the INS do not universally assign an INS value to this specific double salt form, and regulatory acceptance often depends on national or regional food laws and nutrient fortification policies. In contexts where national regulations mirror or reference Codex or JECFA evaluations, the additive may be incorporated into specifications databases, though direct evidence of an international JECFA specification entry is not confirmed in the d sources. As such, its international regulatory presence should be verified against local food additive lists and regulatory authorities’ approvals. Consumers and industry stakeholders should consult relevant regulatory texts in their jurisdictions to confirm permitted uses, labeling requirements, and any specific limits on usage levels for nutrient supplement forms of pantothenic acid. The existing regulatory citation under U.S. law provides a clear reference point for acceptance and conditions of use within that jurisdiction, while international status may require further confirmation against regional additive schedules.

Taste And Functional Properties

Calcium pantothenate calcium chloride double salt, as a nutrient supplement ingredient, generally exhibits characteristics typical of mineral vitamin salts where inherent taste qualities are not the primary driver of use. In its powdered form, the additive is expected to have minimal or subtle sensory impact when incorporated at levels that support nutrient enrichment, given that higher concentrations of mineral salts can sometimes contribute mild saline or mineral notes. However, formulations employing this additive are typically designed to minimize sensory effects while achieving the desired nutrient contribution. Formulators consider the balance between functional performance and sensory neutrality when selecting nutrient supplement forms. From a functional standpoint, calcium pantothenate calcium chloride double salt is water soluble, enabling it to disperse in aqueous food systems such as beverages, nutritional drinks, and fortified hydration products. Solubility in water supports uniform distribution of the nutrient throughout the food product, which is important for consistent labeling and consumer intake. The stability of the additive under typical food processing conditions, such as moderate heat or pH variation, contributes to its functional utility. However, as with many vitamin-based ingredients, extreme processing conditions or prolonged storage under adverse conditions (e.g., high heat, light exposure) can challenge stability, and formulators may need to take such factors into account when designing fortified products. Overall, calcium pantothenate calcium chloride double salt provides a balance of functional properties that support its role as a nutrient supplement, offering water solubility, compatibility with a range of food matrices, and minimal adverse sensory impact at fortification levels. These characteristics make it a practical choice for food manufacturers seeking to enhance the pantothenic acid content of products without compromising quality or consumer acceptance.

Acceptable Daily Intake Explained

In regulatory science, the concept of an acceptable daily intake (ADI) refers to the estimate of the amount of a substance, expressed on a body weight basis, that can be consumed daily over a lifetime without appreciable health risk. ADI values are typically derived by expert committees using toxicological data and applying safety factors to account for uncertainties. For calcium pantothenate calcium chloride double salt, specific numeric ADI values have not been identified in the authoritative sources available, and thus quantitative ADI guidance cannot be provided here with confidence. When numeric ADI values are established by expert bodies such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) or regulatory agencies, those numeric thresholds serve as benchmarks for exposure assessment and risk management decisions. For a lay audience, understanding ADI involves recognizing that it is not a recommended intake level but rather a safety threshold below which lifetime exposure is considered unlikely to pose health risks. ADI values consider all available data on toxicity, metabolism, and potential effects at various exposure levels, and include built-in safety margins. In the absence of a confirmed numeric ADI for this specific compound, nutrient intake recommendations for pantothenic acid itself are established by nutritional science bodies rather than specific ADIs tied to additive forms. Nutritional guidelines focus on meeting physiologic needs for essential nutrients like pantothenic acid, while regulatory ADI frameworks address safety of additives based on available data.

Comparison With Similar Additives

Calcium pantothenate calcium chloride double salt is one of several forms of pantothenic acid used in fortified foods and nutritional products. A common related additive is calcium pantothenate itself (not in double salt form), which appears on regulatory positive lists as a nutrient supplement and is used to enhance pantothenic acid content in products such as fortified cereals, beverages, and nutrition mixes. Compared to plain calcium pantothenate, the double salt form may offer different handling or solubility characteristics that influence formulation choices. Other vitamin-related nutrient supplements include water-soluble vitamin salts like ascorbic acid (vitamin C) salts and various B-vitamin mineral complexes used in fortified foods. These additives share functional similarities in that they supply essential vitamins, though they differ in chemical structure, stability, and formulation considerations. For example, ascorbic acid and its mineral salts are chosen for their antioxidant properties and vitamin C activity, while B-vitamin complexes like niacinamide provide specific B-vitamin activity. The choice among these nutrient supplements depends on targeted nutrient delivery, stability requirements, and compatibility with the food matrix. Comparatively, minerals such as magnesium or zinc salts are used as nutrient supplements for their respective mineral contributions, and like pantothenic acid derivatives, they are selected based on solubility and sensory impact in foods. While each additive serves a role in nutrient enrichment, their chemical differences, modes of action, and sensory properties distinguish their applications within food formulation.

Common Food Applications Narrative

Calcium pantothenate calcium chloride double salt is incorporated into a variety of fortified and nutrition-focused food products where the enhancement of micronutrient content is a formulation objective. In fortified beverages designed for specialized dietary uses, the additive helps deliver pantothenic acid in a form that is readily dispersed in aqueous matrices. Nutritional drinks and ready-to-consume hydration products often employ nutrient supplements like this double salt to ensure that essential vitamins are present at levels that align with nutritional goals. Because soluble nutrient sources are important for uniform nutrient distribution, this additive supports consistent labeling claims in liquid formulations where consumers expect even nutrient distribution. In powdered nutrition mixes, including those intended for meal replacements or medical nutritional beverages, calcium pantothenate calcium chloride double salt can be blended with other vitamins and minerals to create comprehensive fortification profiles. Powdered products for special dietary use, such as clinical nutrition powders or fortified meal substitutes, rely on nutrient supplement ingredients that maintain stability during storage and reconstitution. The powder form of this additive supports ease of blending, allowing manufacturers to formulate complex nutrient matrices without introducing undue processing challenges or sensory alterations. Beyond beverages and powdered mixes, calcium pantothenate calcium chloride double salt may appear in fortified bars and other solid food products where micronutrient enhancement is desired. In such bars, nutrient supplements are formulated into the matrix to contribute to the overall nutritional profile without affecting texture or taste appreciably. This makes the additive suitable for a range of enriched snack products that target consumers looking for additional vitamins as part of their daily diet. Across these applications, the focus remains on delivering a source of pantothenic acid that meets regulatory definitions for a nutrient supplement while integrating seamlessly into diverse product formats.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 172.330

EFSA

  • Notes: EFSA evaluation not found in sources

JECFA

  • Notes: Specific JECFA evaluation for this compound not found in sourced databases

Sources

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