| Size (♯) | 00 | 0 | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|---|---|
| Volume (mL) | 0.93 | 0.68 | 0.49 | 0.37 | 0.28 | 0.21 | 0.13 |
Gelatin Capsules — QUALI-G™
Pharmaceutical capsules
Gelatin Capsules
High-quality capsules that have been the market standard over many years.
Product Overview
- Gelatin capsules have been widely used around the world for many years.
- Excellent dissolution property.
- Registered on Drug Master Files for the US and Canada.
- 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.
- Preservative-free.
- 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.
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
QUALI-G™ capsules have excellent dissolution properties, with not less than 80% of the capsule contents released within 5 minutes.
Source: In-house data
Test conditions
Capsule size: ♯3
Apparatus: Paddle method, 50 rpm, UV detection
Dissolution medium: water, 900 mL
Capsule fill formulation: 20% acetaminophen mixture
Fill weight: 150 mg
Documentation
We prepare accreditations and/or certifications for QUALI-G™. For further reference, please contact us for further information.
| 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.
