Product Description
Titanium Dioxide Free Vegan Capsule Shells Empty Hard Capsules
BACKGROUND
Titanium Dioxide Free Vegan Capsule Shells has been produced by Le-Nutra in order to meet the increasing demand of healthy and clean product, more important is to meet people's attitude and awareness of a healthier life style. There was discussion long before in 2017 that taking Titanium Dioxide may face the risk of harming body health. Even at that time the statistics were not enough and require more studies, it still caused lots of debates in public. Early in 2020, France has stopped selling food that contains TiO2. An d on May 2021, EU had announced that it will be not allowed for all the foods that circulated in EU member states to contain TiO2(Titanium Dioxide) for this substance is bad for human health and harmful for body cell.
Food grade Titanium Dioxide can be referred to as white pigment, non-toxic, tasteless, edible, used in food without chemical reflection, directly added to food can be filled with only a few thousandths, play a whitening shielding role, widely used in flour, beverages, meatballs, fish balls, aquatic products, candy, capsules(commonly used in the processing of white opaque capsules and cellulose capsule for medicines), jelly, ginger, tablets, lipstick, toothpaste, children's toys, pet food and other white food.
Although it had been used for many years in food industry, now with the prohibition going on, it had affected TiO2 manufacture, food supplements capsules factory and also customers.
For the past year, our science department have spent much time and resources trying which substance would be the perfect alternative white pigment to replace TiO2. And finally all the efforts paid well.
Until now, we have exported Calcium Carbonate Vegan Capsule Shells TiO2 free and Zinc Oxide Vegan Capsule Shells TiO2 free to many countries in Europe, including Serbia, Switzerland, Belgium, Holland, etc. And just as we had expected, the feedback were great and satisfying. We are always looking for new and good materials to improve the quality of our capsule shells and strive to make the best products for our customers.
Certificate of Analysis
| Items |
Standards |
Results |
|
Appearance
|
This product is a cylindrical hard capsule with a cap and body section.The shape,size,color and luster of the capsules should be uniform. Almost odourless. |
Conform
|
| Identification(1),(2), (3) |
Should be positive |
Conform |
| Degree of tightness |
Leak less than 1 per ten grains |
Conform |
| Friability |
Broken less than per fifty grains |
Conform |
| Lubricant content |
≤0.5% |
0.01% |
| Loss on drying |
≤8.5% |
4.0% |
| Disintegration Time |
≤30 min |
11′ 00′′ |
| Residue on ignition |
≤3.0%(Transparent) |
≤6.0%(Colored) |
0.6% |
| Heavy metals |
≤10 ppm |
Conform |
| Lead |
≤2ppm |
Conform |
| Cadmium |
≤1 ppm |
Conform |
| Arsenic |
≤1 ppm |
Conform |
| Mercury |
≤0.1ppm |
Conform |
|
Microorganism
|
Aerobe: ≤1000cfu/g |
Less than 10cfu/g |
| Molds&Yeasts: ≤100cfu/g |
Less than 10cfu/g |
| E.Coli: Unallowed to be detected in 1g. |
Negative |
| Salmonella: Unallowed to be detected in 10g |
Negative |
| Conclusion |
This result complies with quality standard of empty capsules made of Hypromellose |
What did we use to replace TiO2?
For pharmaceutical grade Titanium Dioxide Vegan Capsule Shells, it is more important to put customers’ health into top priority. So what could we use to replace TiO2 as the role of whitening coloring agents?
CaCO3(Calcium Carbonate) and ZnO(Zinc Oxide) are the answers. They are both edible, can be used as white pigment, and most important, safe for human consumption, which added all together are the perfect ingredients for making white HPMC empty capsule shells. vegan capsule shells we made are safe and meet the EU regulations. The white HPMC capsule TiO2 Free produced by the Le-Nutra’s upgraded process have a brighter and whiter color, and a more uniform and fine texture.
Besides white empty capsules, we have also other colors: green, red, yellow, etc.
Product Introduction of Capsule Shell
Vegan Capsule Shells is mainly used for holding solid and liquid medicines. Such as homemade bulk, health products, pharmaceuticals, etc., for the user to solve the problem of difficult to enter the mouth, poor taste, the real realization of good medicine is no longer bitter.
Capsule shell are becoming more and more popular. Firstly, they are the most popular dosage form because of their slender shape and ease of swallowing; in addition, they are very effective in masking the unpleasant taste and smell of the contents. Capsules are available in a variety of sizes, including size 00, 0L, 0, 1, 2, 3, 4, and other sizes. The capsules can also be printed, logoed and patterned to give a unique and customised look.
Vegan Capsule Shells Titanium Dioxide Free are one of the most common choices for pharmaceutical filling and occupy an important position in the pharmaceutical manufacturing industry. As the quality and material of the empty capsule shell directly affects the effectiveness and safety of the medicine used, it is often used as special packaging for medicines or health products that are odorous, sensitive to light or in humid or hot conditions. In the production of empty capsules, no bonding or additional pressure is required. In addition, the specific capsules disintegrate easily in gastric juices. Compared to tablets and pills, capsules can provide better bioavailability and offer other advantages in terms of ease of preparation, transport and use as well as safe, void-proof packaging.
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