Product Description
Product Background of HPMC Capsule Shell white Titanium Dioxide Free
Titanium Dioxide Free Capsule 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.
Until now, we have exported Calcium Carbonate Capsule TiO2 free and Zinc Oxide Capsule 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
| Product Name |
Vegetable Empty Capsule(HPMC CAPS) |
Code Number |
LEN-111 |
| Capsule Size |
00# |
Capsule Colour |
Opaque White |
| Net weight per capsule |
122±8 (mg) |
Titanium Dioxide(%) |
Free |
| Batch Number |
LEN-20220405 |
Manufacturer Date |
2022-04-05 |
| Report Date |
2022-04-23 |
Expiration Date |
2027-04-04 |
| Quantity |
7,000,000 pcs |
Packaging |
70,000pcs/carton |
| 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% |
0.02% |
| Loss on drying |
≤8.5% |
5.6% |
| Disintegration Time |
≤30 min |
11′ 00′′ |
| Residue on ignition |
≤3.0% |
0.7% |
| 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 |
Product Introduction of HPMC Capsule Shell white Titanium Dioxide Free
For pharmaceutical grade Titanium Dioxide Free Capsule, 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.
Product Application of HPMC Capsule Shell white Titanium Dioxide Free
EMA explained that titanium dioxide is in oral solids (for example, tablets, soft capsules, hard capsules, granules/powders for oral solutions and oral suspensions) and semi-solid dosage forms (for example, oral pastes, oral gels) It is used "very frequently" as a sunscreen and colorant, including in "many essential drugs" such as antidiabetics and antibiotics. TiO2 is also present in dosage forms administered by routes other than oral, such as products for skin, inhalation (capsule shell), oral mucosa, sublingual, transdermal and vaginal use. Therefore, the promulgation of this directive affects many drugs.
The European Medicines Agency (EMA) found that requiring drugmakers to replace titanium dioxide (TiO2) in medicines “almost certainly will lead to severe drug shortages and discontinuations, and withdrawals will have a significant impact on patients and animals.”
Now our company has developed a Vegetable White Capsule TiO2 Free, which meets European regulations and guarantees health. We have upgraded the production process, and now the quality of the products manufactured is brighter, whiter, more uniform and finer than before. Has become our best-selling product.
Product Package
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