Product Description
Product Introduction of HPMC Veg Capsule Titanium Dioxide Free
Food Supplement Capsule TiO2 Free has released by Xi'an Le Nutra. We all know that ordinary white opaque capsules contain titanium dioxide. In 2021, EU had required that all capsules not contain titanium dioxide, because studies have shown that it may cause cancer.
Vegan Capsule Shells white without TiO2 produced by Le-Nutra do not contain titanium dioxide and have been exported to many European countries, and have been internationally recognized. This technology is currently very few on the market, and our technology has also been recognized by customers.
It has been over a year since our company had developed HPMC Empty Capsule TiO2 free. This product is an opaque capsule without titanium dioxide, instead we have used Calcium Carbonate and Zinc Oxide as alternatives, which is safer and meets EU regulations. The white HPMC capsule TiO2 Free produced by the upgraded process have a brighter and whiter color, and a more uniform and fine texture.
Certificate of Anylysis
| 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 Background of HPMC Veg Capsule Titanium Dioxide Free
The EU member states have approved the proposal of the European Commission to ban the use of titanium dioxide E171 (main ingredient: titanium dioxide) as a food additive from 2022. Titanium dioxide is used as a coloring agent in many products, such as opaque capsules, chewing gum, cakes, food supplements, soups and broths. The European Commission believes that titanium dioxide is no longer considered safe as a food additive, especially because concerns about genetic toxicity cannot be ruled out.
Product Upgrade of HPMC Veg Capsule Titanium Dioxide Free
After EU member states ban the consumption of titanium dioxide, are there alternatives? What are the changes to food colorants and opaque capsules? Recently, our factory upgraded the technology and developed the white HPMC Capsule TiO2 Free.
Calcium Carbonate and Zinc Oxide are very safe for human consumption, at the same time they have very good whittening function as coloring agents.
Product Application in The Pharmaceutical Industry
Compared with food, medicines face more serious problems when facing the E171 (TiO2 free) ban. The European Commission asked the European Medicines Agency (EMA) to investigate the discontinued excipients and found that the manufacturer's need to replace the titanium dioxide in the medicines would cause a serious shortage of white HPMC capsule TiO2 Free medicines. This will require investigation of new data related to alternatives, product reformulation, production and manufacturing, dissolution and stability.
Empty Capsule Shell 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.
Product Package
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