| Size (♯) | 00 | 0 | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|---|---|
| Volume (mL) | 0.93 | 0.68 | 0.49 | 0.37 | 0.28 | 0.21 | 0.13 |
Hypromellose Capsules (HPMC Capsules) — QUALI-V®
Pharmaceutical capsules
Hypromellose Capsules (HPMC Capsules)
The first hypromellose (HPMC) -based capsules, developed by Qualicaps®.
Product Overview
- Hypromellose (HPMC) is 100% plant-based and QUALI-V® includes no animal-sourced raw materials whatsoever.
- Chemically stable and unaffected by drug contents.
- Less affected by mechanical strength by air humidity and suitable for hygroscopic APIs.
- Registered on Drug Master Files for the US and Canada, and on Center for Drug Evaluation in China.
- Manufactured in a validated continuous production environment in compliance with Good Manufacturing Practice (GMP).
- High-quality raw materials in conformity to the JP, the USP/NF, and the Ph. Eur. for specifications are used.
- Free of preservative and allergen (28 raw materials identified as allergens in Japan).
- It is possible to fill with a combination of two or more types of preparations, such as solid, oily liquid, and semi-solid preparations (oily liquid and semi-solid preparations need the band sealing).
Capsule Colors
Hard capsules have the advantage to enhance their distinguishability.
Various capsule colors can be made upon request.
Capsule Printing
More than 90% pharmaceutical capsules made in Qualicaps® are imprinted to enhance distinguishability.
Two imprinting methods are available:
・Offset printing with various color ink
・UV lazer printing with no ink : Qualicaps®'s own technology
Offset printing
Offset printing uses edible ink,
in which various colors are available.
UV lazer printing
UV lazer printing technology utilizes the color change of titanium oxide by UV irradiation.
UV lazer can print fine design to capsules.
| Offset printing | UV lazer printing | |
|---|---|---|
| Color | Various | Gray |
| Fineness | Good | Excellent |
Capsule Sizes
Available in 7 sizes, from 00 to 5.
In addition, please contact us for inquiries about the special size.
Also available in size 9 for small animal use.
| Capsules for small animal use. | |
|---|---|
| Capsule sizes (♯) | 9 |
| Capacity | 25 μL |
| Colors | Cap: Clear blue Body: Clear |
Packaging Quantities (number included)
The standard numbers of capsules packed in each case for outside of Japan are as follows.
| Capsule size (♯) | Standard quantities | |
|---|---|---|
| 00 | 70,000 | |
| 0 | 90,000 | |
| 1 | Transparent capsules | 100,000 |
| Opaque capsules | 125,000 | |
| 2 | 150,000 | |
| 3 | 200,000 | |
| 4 | 250,000 | |
| 5 | 400,000 | |
Test Data
Dissolution Test
No difference in the rate of dissolution of QUALI-V® in water, 1st fluid for dissolution test (simulated gastric fluid), or 2nd fluid for dissolution test
(simulated intestinal fluid).
Source: In-house data
Test conditions
Capsule size: ♯3
Apparatus: Paddle method, 50 rpm, UV detection
Dissolution media: water, 1st fluid for dissolution test, or 2nd fluid for dissolution test, 900 mL each
Capsule fill formulation: 20% acetaminophen mixture
Fill weight: 150 mg
Brittleness Test
Capsules are evaluated by pressing 100 capsules at 0.37 MPa for 15 seconds in a dedicated testing apparatus and checking for broken capsules.
QUALI-V® capsules are more resistant to brittleness than QUALI-G™ capsules when compared at the same moisture content, which is an advantage when handling hygroscopic APIs.
Relationship with Relative humidity
Source: In-house data
Relationship with Capsule moisture content
Source: In-house data
Test conditions
Temperature: 25.0±3.0 ℃
Documentation
We prepare accreditations and/or certifications for QUALI-V®. For further reference, please contact us for further information.
| Kosher Certification (Copy) | ||
| Residual Solvents Statement | BSE/TSE Statement | Elemental Impurities Statement |
| GMO Statement | Allergen Statement | Melamine Statement |
| Nitrosamines Statement | Titanium Oxide Statement | Gluten Statement |
| Irradiation Statement | ||
| SDS | Capsule Specifications | Flow of Manufacturing Capsules |
| Test Methods | Capsule Theoretical Formula | COA Sample |
Additionally, Qualicaps® received ISO9001 and ISO14001 certification.
See ″ISO Management″ for further details.
Related Products
Trademark
QUALI-V is a registered trademark of Qualicaps in China, India, US, Canada, EU, Switzerland, and UK.