Nitrosamine Reduction Solutions
Ceolus™ MCC Keeps Nitrites to 0.1 ppm
Why Choose Ceolus™ MCC for Nitrosamine Management?
・Verified Nitrite Levels ≤ 0.1 ppm, Documented in Certificate of Analysis
・Consistent Testing Indicates Low Nitrite Concentration
・Trusted Performance in 200+ Projects for Nitrosamine Risk Reduction
Low Nitrite Levels in Ceolus™ MCC
Asahi Kasei's Ceolus™ MCC provides nitrite concentrations of 0.1 ppm or less across our current primary product lines. Test results confirming these levels are provided in every Certificate of Analysis.
| Grade | Number of Batches Tested | Number of Batches with less than LOD (0.008 ppm) |
Nitrite max observed (ppm) | |
|---|---|---|---|---|
| Ceolus™ KG Highly compactible MCC with fibrous particles |
KG-1000 | 20 | 18 | 0.011 |
| KG-802 | 30 | 27 | 0.014 | |
| Ceolus™ UF Porous MCC with balance of compactibility and flowability |
UF-702 | 32 | 30 | 0.010 |
| UF-711 | 26 | 25 | 0.010 | |
| Ceolus™ PH High-quality standard grade |
PH-101 | 39 | 15 | 0.034 |
| PH-102 | 52 | 21 | 0.026 | |
| PH-200 | 13 | 5 | 0.027 | |
| PH-301 | 12 | 8 | 0.027 | |
| PH-302 | 10 | 8 | 0.016 | |
Batches in the 1st Manufacturing Site (Nobeoka)
Results derived from testing done internally at Asahi Kasei
Trend Analysis: Nitrite Value of Ceolus™
High Performance MCC
Ceolus™ KG
Ceolus™ KG is a highly compactible MCC with fibrous particles, ideal for poorly compactible and high-dose formulations. It addresses tableting issues like insufficient hardness, sticking, and capping.
Functional benefits
- Enables poorly compactible and high-dose formulations
- Resolves tableting issues: insufficient hardness, sticking, capping, high friability
- Supports unique and patient-friendly dosage forms: MUPS, ODT, multi-layer tablets, multi-API combination tablets, small tablets, mini tablets
- Allows low-pressure tableting: suitable for pressure-sensitive API tablets and coated granules
Ceolus™ UF
Ceolus™ UF is a porous MCC that balances compactibility and flowability, ensuring a good balance of tablet hardness and disintegration. It addresses tableting issues like insufficient API content uniformity and over-lubrication.
Functional benefits
- Balances tablet hardness and disintegration
- Resolves tableting issues: insufficient API content uniformity, over-lubrication
- Supports poorly flowable and low-dose formulations
- Enables high-speed tableting
Ceolus™ MCC Grade Lineup
| Grade | Average particle size (μm) | Bulk density (g/cm3) | Repose angle (°) | Loss on drying (%) | Water absorption (%) | Oil absorption (%) | |
|---|---|---|---|---|---|---|---|
| Ceolus™ KG Highly compactible MCC with fibrous particles |
KG-1000 | 50 | 0.12 | 57 | 2.0-6.0 | 290 | 210 |
| KG-802 | 50 | 0.21 | 49 | 2.0-6.0 | 230 | 160 | |
| Ceolus™ UF Porous MCC with balance of compactibility and flowability |
UF-702 | 90 | 0.29 | 34 | 2.0-6.0 | 240 | 160 |
| UF-711 | 50 | 0.22 | 42 | 2.0-6.0 | 240 | 150 | |
| Ceolus™ PH High-quality standard grade |
PH-101 | 50 | 0.29 | 45 | 2.0-6.0 | 200 | 120 |
| PH-102 | 90 | 0.30 | 42 | 2.0-6.0 | 200 | 140 | |
| PH-200 | 170 | 0.35 | 36 | 2.0-6.0 | 200 | 140 | |
| PH-301 | 50 | 0.41 | 41 | 2.0-6.0 | 150 | 90 | |
| PH-302 | 90 | 0.43 | 38 | 2.0-6.0 | 170 | 100 | |
| PH-F20JP | 20 | 0.23 | ≦60 | ≦7.0 | 220 | 100 | |
Note: Values shown are for reference only and are not product specifications.
Map of Ceolus™ Compactibility vs. Flowability
MCC Sphere
Celphere™
A 100% MCC sphere, Celphere™ facilitates precise dissolution profiles of controlled release formulations by its high sphericity and narrow particle size distribution.
Functional benefits
- Facilitates precise dissolution profile of controlled released formulation
- Yield improvement
Reduces agglomeration, tolerance with high stress and coating machine varieties
General properties
| Grade | Particle size range (μm) | Sphericity | Bulk density (g/cm³) | Water absorption (%) |
|---|---|---|---|---|
| CP-102 | 106-212 | 1.2 | 0.83 | 100 |
| CP-203 | 150-300 | 1.1 | 0.87 | 100 |
| CP-305 | 300-500 | 1.1 | 0.97 | 110 |
| CP-507 | 500-710 | 1.2 | 0.97 | 70 |
| CP-708 | 710-850 | 1.2 | 0.93 | 65 |
All values are presented only for the purpose of basic reference and not as specifications.
Grade lineup
Solutions Made Possible by Asahi Kasei MCC Products
Capping Prevention
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- Problem
- Increased compression force resulting from poor API compatibility and high API dosage increases the risk of capping.
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- Solution
- Highly compactible MCC reduces the risk of capping even at high compression forces by strengthening the tablet bondings.
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- Product
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Ceolus™ KG
Balance of Tablet Hardness and Disintegration
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- Problem
- In high-shear granulation, achieving the target tablet hardness and disintegration is challenging because granulation conditions affect these parameters.
-
- Solution
- Porous MCC with high swellability helps minimize the impact on tablet hardness and disintegration/dissolution during granulation.
-
- Product
-
Ceolus™ UF
Controlled release formulation
-
- Problem
- Granules are often damaged in the coating process and damaged granules affect dissolution.
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- Solution
- A 100% MCC sphere can reduce impact on dissolution by its mechanical strength.
-
- Product
-
Celphere™
Asahi Kasei Healthcare Materials Division
The Asahi Kasei Healthcare Materials Division provides MCCs for oral solid dosage forms in pharmaceuticals and nutraceuticals.
We have supplied MCC products to the Japanese pharmaceutical market for over 50 years, achieving a majority market share due to their reliability.
A significant advantage of our MCC products is their ability to support challenging and innovative formulations for pharmaceuticals and nutraceuticals that our customers are bringing to market.
Experience the Ceolus™ Advantage Today
Discover the superior quality of Ceolus™ MCC and enhance your pharmaceutical formulations with our premium materials. Request your free sample today to take the first step towards creating safer, more reliable products.