Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
AUGUST 2018
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Innovations in High-Purity Minerals
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Ensuring Product Consistency with High-Purity Minerals
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
ADVANTAGES OF HIGH-PURITY MINERALS FOR PRODUCT FORMULATORS
W
hen it comes to the purity of mineral ingredients, it’s one thing to simply meet the established limits of the United States Phar-
What Is Ultra-Pure?
Just how pure is “ultra-pure”? Calcium hydroxide, for example, is permitted to contain arsenic levels of less than 3 ppm and lead levels of 2 ppm under the FCC macopeia (USP), monograph. The the European Pharultra-pure calcium For applications where the macopoeia (EP), hydroxide from Jost and/or the Food vagrant metal limits established Chemical, by comChemicals Codex parison, is held to (FCC). It’s an entirely on the USP, EP, or FCC monographs the limit of 1 ppm different matter to simply aren’t stringent enough, for both arsenic achieve the high-pulead, and the rity levels necesformulators must choose ultra-pure and actual product typsary to truly ensure minerals that guarantee exceedingly ically comes in at product safety and less than 0.2 ppm performance. For aplow levels of heavy-metal contamiarsenic and less plications where the than 0.1 ppm lead. vagrant metal limnants like lead, arsenic, cadmium, Across all of its established on mercury, and more. the company’s the USP, EP, or FCC Ultra-Pure mineral monographs simply salts, the maxiaren’t stringent enough, formulators must choose mum level for lead, arsenic, and cadmium is 1 ultra-pure minerals that guarantee exceedingly ppm, and for mercury, the maximum is 0.1 ppm. low levels of heavy-metal contaminants like lead, Going well beyond what is required in the USP, EP, arsenic, cadmium, mercury, and more. 2
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Advantages of HighPurity Materials for Product Formulators
Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
and FCC monographs, these high-purity minerals allow customers to meet numerous application goals they might not be able to otherwise.
um, therefore, has made it possible for supplement makers to develop new products and to improve the quality of their existing products. Lead, one of the most toxic metal contaminants, Health Concerns is especially dangerous to young children. They absorb calcium much more readily than do adults, Health is, of course, often the prime concern when but their bodies cannot distinguish between lead it comes to reducing the level of heavy-metal impuand calcium. What’s more, for products sold in rities in mineral salts. California, lead Aluminum, for one, is becomes especially known to be toxic to problematic for a the nervous system, The Nielsen report stated, different reason. and emerging research According to the has found it may even “93% of U.S. households state’s Proposition be linked to Alzheimer’s 65 legislation, proddisease. Understandhave purchased a clean ucts containing lead ably, such findings have label product at grocery at even very low generated a significant levels must carry a demand for minerals stores, while 70% have label warning of powith low aluminum purchased at a mass tential carcinogens. levels, especially for use Because Jost’s calin products designed for merchandiser/supercenter cium citrate is now infants and children. available with lead Historically, it has and 31% at club stores.” levels of less than been difficult to ensure 0.03 ppm—a virtuhigh degrees of purity. Before Jost developed ally non-detectable a method for producing high-purity minerals, amount—manufacturers can feel more confident calcium citrate often contained aluminum levels in the safety of their product for children, and are of approximately 70–80 ppm, for example. Today, able to meet Proposition 65’s statute. Jost manufactures calcium citrate with aluminum Jost’s high-purity technology also reduces the levels of less than 5 ppm. The high-purity calciamount of metals like manganese and cadmium,
Ultra-Pure Calcium: When Purity is a Must Jost proprietary technology results in a step change in purity for calcium salts with levels 25 to 50 times lower than materials produced using alternate manufacturing technology. Jost’s improved technology can be applied to the manufacture of any calcium salt. Click to learn more about Calcium products 3
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Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
which can also introduce troubling mineral impurities for child-oriented products. Manganese is retained by newborn infants at a rate that is three times higher than that of adults (and sixfold higher in premature infants), making it particularly concerning in products for babies. Fortunately, Jost’s proprietary technology allows for mineral products with manganese levels of less than 5 ppm, and commonly less than 1 ppm. Cadmium, meanwhile, can lead to kidney disease and serious liver damage following excessive exposure. Soybased infant formulas tend to be more sensitive to cadmium contamination, but Jost’s high-purity minerals boast cadmium levels of less than 0.5 ppm, ensuring minimal exposure in sensitive groups like children.
Applications for High-Purity Minerals Besides health, there are plenty of other reasons why high-purity minerals allow for applications where standard minerals may fall short. Jost has worked with chemical manufacturers for which color was a concern when using calcium hydroxide; high levels of iron and manganese found in commodity calcium hydroxides would contribute to an unacceptable color in the finished product. By using Jost’s high-purity calcium hydroxide, these manufacturers could consistently produce an appropriately colored material. Certain impurities may also disrupt the chemical processes necessary to manufacture a product. Before turning to Jost, one customer found that naturally occurring silicon in commodity calcium hydroxide was interfering with a synthesis operation. Of course, there are other ways to remove silicon 4
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Low Heavy Metal Minerals We manufacture a line of Ultra Pure products with impurity levels much lower than the USP/ EP/FCC monographs. Click to learn more about Ultra Pure Minerals
Jost’s high-purity technology also reduces the amount of metals like manganese and cadmium, which can also introduce troubling mineral impurities for child-oriented products. impurities from finished products, but as they tend to be costly and time-consuming, the customer chose to focus on the purity of its raw-material minerals instead. By switching to Jost’s high-purity calcium hydroxide in the reaction sequence, they were able to ensure a lower silicon content from the start, thereby eliminating the need to remove silica impurities post-reaction. AUGUST 2018
Jost isof the Advantages High-leading Ensuring Product Puritysupplier Materials of for high purity Consistency with Product Formulators High-Purity Minerals Calcium Citrate Calcium Hydroxide Dibasic Calcium Phosphate Tribasic Calcium Phosphate Other Calcium Salts
It’s In The Details.
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
Ultra Pure Minerals for applications where purity is a must. At Jost Chemical Co. we manufacture our Calcium products with exceptionally low levels of Al, Pb, Cd, As, and Mn. Our high purity mineral salts are manufactured using innovative, controlled processes, which yield products that go beyond the established high purity standards. Our 30-year history of manufacturing success has established Jost as the leading supplier of these high purity USP/EP/FCC mineral salts. Jost products are manufactured in a cGMP compliant, FDA-registered facility. Our products are fully reacted, consistent from lot-to-lot, and meet all customer requirements.
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Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
ENSURING PRODUCT CONSISTENCY WITH HIGHPURITY MINERALS
I
t’s no secret how Jost Chemical has established its trusted reputation over the more than 30 years since its founding: by paying close attention to every step of the production process to ensure the highest standards are met. That starts with comprehensive customer consultation, continues through careful raw ingredient sourcing, chemical processing, and sample testing, and culminates in industry-leading manufacturing, packaging, and distribution. Jost is an FDA-registered manufacturer of high-purity mineral salts. The company’s product go well beyond the levels of purity outlined in the United States Pharmacopeia (USP), the Food Chemicals Codex (EP), the 6
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National Formulary (NF), the European Pharmacopeia (EP) and the American Chemical Society (ACS). Jost’s manufacturing practices follow a rigorous current good manufacturing practices (cGMPs) system that is verified through FDA audits with the underlying philosophy that finished product testing alone cannot provide a sufficient guarantee of quality. That’s why all incoming materials are inspected before the plant even begins to use them. Quality testing continues at key stages throughout the manufacturing process, and all finished goods are tested before distribution. Of course, Jost’s established success record of quality assurance wouldn’t be possible without
That starts with comprehensive customer consultation, continues through careful raw ingredient sourcing, chemical processing, and sample testing, and culminates in industryleading manufacturing, packaging, and distribution.
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Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
state-of-the-art equipment and knowledgeable technicians working in Jost’s quality compliance department. In addition to the broad range of advanced product testing Jost conducts in house, the company’s technicians are more than willing to provide hands-on technical support as needed, as well as documentation to verify all ingredients are fully traceable. It’s thanks to this level of institutional scrutiny that Jost’s final products consistently satisfy all customer requirements for quality, purity, potency, and regulatory compliance.
Particle Size Consistency
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be destroyed. Since Jost’s mineral salt was the largest component of the formula, the customer suspected that changing the particle size distribution of the mineral salt used in the product might solve the problem. Jost technicians then spent nine months measuring and recording particle size distribution, calculating the resultant surface area, and recording the customer’s measurements of the viscosity of the finished product. As a result of their efforts at honing in on the ideal particle size, the customer reported back that the small change made in particle size distribution resulted in a higher average viscosity and eliminated the need for them to reject any of the finished product. It is precisely this sort of attention to detail, even when it involves something as minute as a very small change in particle size, that allows Jost to consistently deliver a product that’s tailored to the highly specific needs of every customer. By rigorously following cGMPs, providing industry-best expertise, and promising the attention necessary to deliver a quality product on time, every time, Jost products are formulated to stand up to even the most demanding specifications.
Particle size is one of the most important considerations in many applications involving mineral salts and a crucial consideration in establishing product consistency. Even the slightest variation in particle size between batches can fundamentally alter the texture or density of a finished product and render it unusable.
Particle size, for instance, is one of the most important considerations in many applications involving mineral salts and a crucial consideration in establishing product consistency. Even the slightest variation in particle size between batches can fundamentally alter the texture or density of a finished product and render it unusable. That’s why Jost closely controls both particle size and particle size distribution and works with its customers to help achieve the desired particle size in every batch. In one case, a customer came to Jost for help because the viscosity of their finished product was inconsistent, forcing low-viscosity batches to 7
Innovative Approaches to High-Purity Minerals
AUGUST 2018
FDA REGISTERED / cGMP / USP • EP • JP • FCC • ACS Advantages of HighEnsuring Product Purity Materials for Consistency with Innovative Approaches The Science Behind Product Formulators High-Purity Minerals to High-Purity Minerals Purity, Quality, and Trust
We are the leading supplier of high purity Calcium, Magnesium and Zinc Citrate At Jost Chemical Co. we manufacture our family of Calcium, Magnesium and Zinc Citrate products with exceptionally low levels of heavy metals. Our high purity specialty chemicals are manufactured using innovative, controlled processes that yield products that go beyond the established high purity standards. With 30 years of experience, Jost manufactures high purity USP/EP/FCC mineral salts in cGMP compliant, FDA-registered facilities. Our products are fully reacted, consistent from lot-to-lot and meet all customer requirements.
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Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
INNOVATIVE APPROACHES TO HIGHPURITY MINERALS
J
ust as the applications for high-purity or downright impossible. What’s more, magneminerals are incredibly unique, so too sium salts are also very difficult to tablet. must be the solutions that manufacJost’s calcium magnesium citrate co-salt adturers devise to meet those many dresses both of those issues. When used in applications. water solutions, it And with customers will not harden and across industries as displays superior When used in water soluvaried as nutraceutistability, blend ability, tions, [Jost’s calcium magcals, pharmaceuticals, and flow ability comoral care, laboratory pared to blends of nesium citrate co-salt] will reagents, and more, Jost calcium citrate and Chemical has made it a magnesium citrate. not harden and displays sufundamental part of its Even over extended perior stability, blend ability, business to provide innoperiods of time, the vative solutions to suit co-salt stays in susand flow ability compared very particular needs. pension and provides to blends of calcium citrate One example of Jost’s excellent mouth feel. innovation is a unique And when it comes and magnesium citrate. calcium magnesium to tableting, Jost’s citrate co-salt. Nutritioncalcium magnesium al companies that have worked with calcium and citrate co-salt has been found to have superior magnesium citrates together can testify, the two compressibility to both calcium citrate and magcompounds have a strong tendency to extensivenesium citrate, opening the door for tablet applily thicken in solutions, and, over time, completely cations that were previously out of reach. solidify into a cement-like mixture. This makes Homogeneity and segregation studies have dosing from the finished goods container difficult demonstrated the co-salt is a unique compound,
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Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
not just a simple blend of calcium citrate and Another area where Jost has worked to solve industry problems is with microencapsulation of magnesium citrate, so Jost has taken the step its mineral salts. Its line of JOSTCOTE® microof submitting a New Dietary Ingredient notificaencapsulated tion to FDA for the mineral salts compound. It is currently inJost can consistently provide formulated with a clude copper 2:1 ratio of calcitri-calcium phosphate with aluminum gluconate, ferum to magnesium rous fumarate, contaminants below 5 ppm, opening (the same ratio as magnesium up new markets for companies oxide, mangathe recommended nese sulfate, daily requirement looking to deliver high-purity products zinc oxide, and for the minerals), to infants and children, who are many others— and it’s currentall of which are especially vulnerable to ingesting ly available in a encapsulated aluminum—a known toxin to the purified powder for using Jost-engiaqueous soluneered particle nervous system. Similarly, Jost now tions or a purified coating technolmanufactures calcium citrate with granular form for ogy. The techaluminum levels of less than 5 ppm. nology works to tableting. And like mask odor and many other Jost taste of the mineral products, active substances, as well as minimize the interthe co-salt has low level of vagrant metals, inaction of formulation components which might cluding a lead maximum limit of 0.2 ppm. cause stability issues in the finished product.
Microencapsulated Products Engineered for the nutritional and food fortification markets, this advanced particle-coating technology has unlocked possibilities for our customers seeking the finest quality in their finished product. Click to learn more about JOSTCOTE®
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Microencapsulated Products Video AUGUST 2018
Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
Additionally, JOSTCOTE microencapsulation also allows for flexibility in matrix-coating options and enhanced particle size control, which can help achieve the desired mouth feel and texture of the finished product. The microencapsulated mineral salts are appropriate for finished dosage forms such as chewable tablets, nutrition bars, rapid-dissolve tablets, and sachets.
Jost now manufactures calcium citrate with aluminum levels of less than 5 ppm. Before Jost brought its high-purity technology to market, calcium citrate typically carried aluminum levels of approximately 70–80 ppm. In one instance where a nutraceutical manufacturer was struggling to mask the taste of zinc, the active ingredient in its product, Jost’s research and development team helped the customer reach a solution in just three weeks. By working to identify matrix components that met both the regulatory requirements of the product’s intended market and the customer’s functionality requirements, Jost applied its microencapsulation technology to successfully meet the texture and mouth feel attributes preferred by a consumer taste panel. For another customer, this time working with an animal health product where an unwanted ingredient interaction was degrading the finished product, Jost advised the customer to replace the copper salt used in the formula to increase product shelf life. After reviewing Jost’s range of 11
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Innovative Approaches to High-Purity Minerals
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fully reacted copper salts and the related bioavailability data published for the target market, the customer’s regulatory group selected an optimal copper salt. Jost’s research and development team then produced microencapsulated copper salt samples at lab scale for the customer to evaluate. In terms of high-purity minerals, Jost has led the way with its work eliminating heavy-metal contaminants from minerals at purity levels previously out of reach. Take tri-calcium phosphate, a min-
Calcium Magnesium Co-Salt Article Calcium Magnesium Co-Salt Video eral that frequently contains aluminum levels of 125 ppm or higher. Jost can consistently provide tri-calcium phosphate with aluminum contaminants below 5 ppm, opening up new markets for companies looking to deliver high-purity products to infants and children, who are especially vulnerable to ingesting aluminum—a known toxin to the nervous system. Similarly, Jost now manufactures calcium citrate with aluminum levels of less than 5 ppm. Before Jost brought its high-purity technology to market, calcium citrate typically carried aluminum levels of approximately 70–80 ppm. AUGUST 2018
Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
THE SCIENCE BEHIND PURITY, QUALITY, AND TRUST An interview with Joseph Hardimon, Jost Chemical Co.
M
ineral supplements are essential for supporting optimal health and wellness by bolstering bone health, ensuring proper nerve responses, sustaining heart health, and more. Not all minerals are the same. The road to ensuring supplement safety and efficacy may start with the process by which suppliers create and ensure high-quality materials. Here Nutritional Outlook caught up with Joseph Hardimon, a long-time Jost Chemical Co. (St. Louis, MO) scientist who is currently the firm’s research and development manager, to discuss how Jost’s scientific approach to minerals supports supplement quality and innovation. Nutritional Outlook: Why do you feel it is important for supplement makers to use high-purity mineral salts over other similar raw materials? Hardimon: In terms of their value to human health, the most important attribute of high-purity mineral salts are their low levels of heavy metals like arsenic, mercury, lead, and cadmium. Exposure to heavy metals have long been known to promote cancer, cause digestive problems, affect cognitive learning, and much more. At Jost Chemical, we strive to achieve low levels of heavy metals because it creates a healthier finished product.
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One example is the prenatal market; what the mother takes, the baby ultimately receives. Studies suggest that exposure to heavy metals may cause brain developmental issues in babies and children. The link between heavy metals and increased cancer risks is well known. More recent findings suggest that aluminum levels in milk replacement formulae may cause brain developmental issues in infants. We tailor the manufacture of our compounds accordingly as we learn about other potential health issues linked to aluminum and heavy metals. For instance, some research also suggests a link between aluminum consumption and Alzheimer’s development in senior citizens. Iron salts are used for milk fortification and adult nutrition products and how it affects the elderly. Jost offers iron salts with low aluminum levels to help address these concerns about aluminum. Another important aspect is Jost manufactures fully reactive materials, which leads to much better stability and performance for both formulators and consumers. Jost does not produced blends of raw materials. The last reason why Jost takes pride in our fully reacted, high-purity mineral offerings is to support our customers and their formulation groups. Supplement manufacturers must hit certain limit targets for heavy metal. By offering fully reacted, AUGUST 2018
Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
high-purity materials with very low levels of heavy metals, formulators know our products will not contribute a high heavy metal burden into their formulations. Nutritional Outlook: What exactly is “high purity” from Jost’s perspective? Hardimon: Two different regulatory documents define heavy metal limits in pharmaceutical and food products. The first is the International Conference on Harmonization (ICH) Q3D Guideline for Elemental Impurities, which establishes limits on the presence of potentially toxic elemental impurities (i.e., heavy metals) in pharmaceutical products intended for human use. Jost’s materials comply with US Pharmacopeia (USP) Chapter <232> for Elemental Impurities. Jost’s extremely pure products help our customer base meet ICH Q3D requirements for their end products that are intended for human use. Those limits are often in the parts-per-million range. Typically, Jost achieves far lower levels in the sub-part per million level on our Certificates of Analysis. So, we say our products are of a high purity because we can easily manufacture them below the limits set forth by ICH Q3D and USP General Chapter <232>.
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
Hardimon: Jost was proactive regarding the new guidelines for elemental impurities since USP started working to address them a few years before their 2018 implementation. Well before the January 2018 date, Jost was in a position of compliance with the new standards because of the way we manufacture and test our materials. Our current customers were aware of our foresight and appreciated this! In addition, Jost also manufactures products that exceed the impurity level standards listed in other monographs such as the European Pharmacopoeia and the Food Chemicals Codex. Again, we don’t just meet the monograph requirements; we are well below maximum limits in most cases.
Jost’s materials comply with US Pharmacopeia (USP) Chapter <232> for Elemental Impurities. Jost’s extremely pure products help our customer base meet ICH Q3D requirements for their end products that are intended for human use.
Nutritional Outlook: USP <232> only went into effect in January 2018. How did this update affect Jost? 13
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Nutritional Outlook: Can you talk a little about how Jost achieves those sub-parts per million levels? Hardimon: Jost Chemical employs proprietary chemical processing that allows us to produce low heavy metal material. It’s not tied to the raw materials themselves, but rather is the result of the chemistry done within our processing tanks. Most manufacturers of mineral salts are not as adept in chemistry as Jost Chemical, so their processes are often reliant upon using a raw material supply that’s already low in a certain heavy metal. They may identify a low-mercury or low-arsenic source of iron to use in their iron salt production process. The problem with that technique is that once the source runs out, they are no longer able to manufacture the material until AUGUST 2018
Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
another similar source is identified. That can lead to supply issues for customers. Conversely, Jost has a heavy metal removal process in-house, so we’re not tied to any particular source of raw material or manufacturer. Jost also does all its testing in-house. Housed in our state of the art analytical laboratories is an inductively coupled plasma mass spectrometer (ICP-MS) system, which is the analytical instrumentation method called for in USP <233> (the methods for USP <232>). We have several scientists who are very well educated and trained on ICP-MS techniques. Jost analyzes our materials as we’re producing them to make sure the heavy metals levels are always low. In addition, the in-house ICP-MS system is a great research tool for helping fine-tune our research and production processes. Having that capability inhouse, and not relying on a third-party laboratory, provides a much faster turnaround time for analytical data for Jost and our customers.
Innovative Approaches to High-Purity Minerals
The Science Behind Purity, Quality, and Trust
For instance, the Research department offers a bi-yearly, nine-week “Chemistry of Jost 101” course open to all Jost employees. It is our goal to make sure that EVERY EMPLOYEE, from equipment/chemical operators to the general office staff understand what is happening in our tanks. That’s why instead of teaching “generalized chemistry”, we teach the chemistry of Jost Chemical. During a nine-week course, we cover and discuss all the reactions we do in our plant. I personally find that if you engage employees in what we’re manufacturing, packaging and selling it brings our business to a whole new level of commitment to quality. Suddenly, you’ve got operations personnel coming to the research department with ideas for improving the process. A new processing step could result from interactions between the operations and research teams that wouldn’t have been there if we hadn’t opened that door between departments. Further, I find that the better educated chemical operators and packagers are, the higher the quality of Jost’s products. The bottom line is that very intelligent people work here, and they’re very engaged in what they do. That’s the reason why Jost is an industry leader! We’ve also taken the class a step further by bringing “lunch and learn-” to our customers both domestically and internationally at their request. It has been very well received and we continue to receive requests to continue this type of external training. Over the course of a
Most manufacturers of mineral salts are not as adept in chemistry as Jost Chemical, so their processes are often reliant upon using a raw material supply that’s already low in a certain heavy metal. They may identify a low-mercury or low-arsenic source of iron to use in their iron salt production process.
Nutritional Outlook: In what other ways do you feel Jost exemplifies its commitment to science and chemistry? Hardimon: Jost Chemical was founded by a chemical engineer, hence our business model is rooted in science. The Jost Research Group extends knowledge of good science into many areas of our company including non-technical departments. 14
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Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
2-4-hour training session, our customers receive a good working knowledge of the chemistry at Jost and our commitment to the highest levels of purity available on the market. Nutritional Outlook: How does Jost’s approach to high-purity differ from others in the marketplace?
Ferrous Sulfate Dried Our Ferrous Sulfate Dried production keeps manganese levels low (less than 100ppm) and consistent, so there are no unexpected spikes of manganese, which can cause your end product to not meet label claim. Click to learn more about our Ferrous Sulfate Dried production SPONSORED BY
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so there’s never going to be a surprise. Jost will never test into compliance. Some companies make large amounts of material and then test multiple batches/lots until they find a sellable portion. From each product’s campaign start-up, Jost consistently manufactures high purity minerals until the last container is loaded onto a customer’s truck.
While microencapsulated products are not compendia monographed, we do consider impurity profiles a crucial factor when we select ingredients to manufacture these microencapsulated products.
Hardimon: Our approach is unique because of the chemical processing steps we spoke about earlier and our unparalleled lotto-lot consistency. Formulators really appreciate this consistency. They like having their formulation’s raw material charges established, allowing them to know quickly what amounts to use. Because of our proprietary controlled in-house chemical processes, our vagrant metals are consistently very low,
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Nutritional Outlook: Let’s shift to encapsulation. Why might a supplement maker use an encapsulated iron, and what might be the benefits to consumers?
Hardimon: Our microencapsulated line is called JOSTCOTE,® which uses USP-, EP- or FCC-grade mineral salts manufactured using GMP methodology at our FDA-registered facilities. While microencapsulated products are not compendia monographed, we do consider impurity profiles a crucial factor when we select ingredients to manufacture these microencapsulated products. For example, if someone is going to buy our microencapsulated ferrous sulfate, the ferrous sulfate we put in that microencapsulate is USPgrade material. In addition, our microencapsulated products exhibit the same extremely low levels of lead, cadmium, arsenic and mercury, and, if it is warranted, chromium or aluminum or manganese as well. Our JOSTCOTE products are basically a two-component product: a mineral salt and the encapsulating matrix. The compounds we use for the encapsulation matrix do not contain any heavy metals. One benefit of microencapsulation is to eliminate unwanted taste and odor. Materials like zinc, AUGUST 2018
Advantages of HighPurity Materials for Product Formulators
Ensuring Product Consistency with High-Purity Minerals
copper, and iron have a horrible taste profile. Our oxygen-barrier coatings not only mask taste, but also odor. Another reason for encapsulation is enhanced mouth feel and texture. Sometimes, salts can be crystalline and they don’t feel quite right on the tongue. Sometimes, they’re granular and feel kind of gritty. If you put an encapsulate around the mineral salt, you can make it smooth and your tongue will not detect it as much. The microencapsulation of materials like ferrous salts can limit or potentially stop oxidation, which is important when you want to be sure you’re delivering iron(II) and not iron(III). Iron(II) and iron(III) are metabolized differently in the body. Keeping the oxygen and humidity out of your active ingredient can also lead to enhanced shelf life. Typical iron salts with a three-year stability profile may last much longer on the shelf when you microencapsulate. Applications and performance of mineral salts benefit from microencapsulation by improving the flow characteristics of powders. Crystallized salts can agglomerate and don’t flow very well, which is problematic when doing blends or making tablets. If you microencapsulate materials, you create a uniform-sized particle that is matched with the other components of a formulation. When you do that, you get very effective homogeneous blending and flowability.
Innovative Approaches to High-Purity Minerals
Microencapsulation also helps with tablet compressibility. Salts that typically have a poor compression profile may be microencapsulated in a matrix that has a superior compression index, thereby allowing tableting of mineral salts without the addition of other excipients.
The microencapsulation of materials like ferrous salts can limit or potentially stop oxidation, which is important when you want to be sure you’re delivering iron(II) and not iron(III). Iron(II) and iron(III) are metabolized differently in the body. Keeping the oxygen and humidity out of your active ingredient can also lead to enhanced shelf life.
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Nutritional Outlook: Are you seeing increased interest in high-purity materials from what you saw years ago? What might be behind some of this increased demand?
Hardimon: We’ve seen an increase in requests for iron(II) salts (ferrous salts) that have a very low iron(III) content (ferric content). There’s also demand out there right now for iron(III) salts (ferric salts) that have a very low iron(II) content. Stopping the oxidation that readily occurs in nature is very hard to do with a transition metal like iron. We have the manufacturing capability to produce very low iron(II) ferric salts, as well as low iron(III) ferrous salts. In addition to typical requests for low heavy metal materials, more and more customers want an iron salt that has low aluminum, manganese and/or chromium. And the only way you can do that is through the processing that Jost utilizes to manufacture its materials. Joseph Hardimon R&D Manager AUGUST 2018