IBUPROFEN DC-100
- CAS Number
- 15687-27-1
- EC Number
- 239-784-6
- Chemical Name
- Ibuprofen
Ibuprofen DC 100 are spherically shaped particles consisting of 100 % Ibuprofen drug substance.Due to its shape and surface structure Ibuprofen DC 100 provides unique product characteristics offering a wide range of applications.
Properties
- Physical Form
- Granules
- Solid
- Spheres
- Pharma and Nutraceuticals Functions
- Anti-Inflammatory
- Pain Reliever
Product families
Applications
- Oral
Product Families
- Active Pharmaceutical Ingredients (APIs)
Other characteristics
- Brand
- IBUPROFEN DC 100
- Synonyms
(+-)-Ibuprofen, (±)-2-(p-isobutylphenyl)propionic acid, (±)-ibuprofen, (±)-p-isobutylhydratropic acid, (±)-α-methyl-4-(2-methylpropyl)benzeneacetic acid, (4-isobutylphenyl)-α-methylacetic acid, (RS)-ibuprofen, 2-(4-isobutylphenyl)propanoic acid, 4-Isobutylhydratropic acid, alpha-(4-Isobutylphenyl)Propionic Acid, alpha-(P-Isobutylphenyl)Propionic Acid, p-Isobutyl-2-phenylpropionic acid, p-Isobutylhydratropic acid, α-(4-isobutylphenyl)propionic acid, α-(p-isobutylphenyl)propionic acid
- Dosage Form
- Orally Disintegrating Tablets (ODTs), Tablets
- Orally Disintegrating Tablets (ODTs)
- Tablets
- Labeling Claims
- BSE-free, TSE-free
- BSE-free
- TSE-free
- Certifications & Compliance
European Pharmacopeia (Ph. Eur.), United States Pharmacopeia (USP)
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Benefits
Ibuprofen DC 100 consists of 100% pure, specifically shaped Ibuprofen. It does not show sticking and picking behavior in high speed tableting
- Features
- Direct compression
- High speed tableting
- Higher productivity
- Taste masking
- ODT and modified release
- High drug load
- Smaller tablets
- Appearance
- White or nearly white particles
- Technology
- Pharmaceuticals & Nutraceuticals
- Main Applications
- Opportunity for long term high speed
- Direct Compression
- Easier coating for taste masking (ODT) and
- extended release formulations
- Smaller tablets / higher drug load.
- API
100% Ibuprofen pellets for Direct Compression and coating processes for taste masking (OTD) & extended release formular
- Manufacturing Technology
- Direct Compression
- Certifications and Compliance
- European Pharmacopeia (Ph. Eur.)
- United States Pharmacopeia (USP)
Technical data
Table 1 of 3
7 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Particle Size Distribution | 200 –500 | μm | — |
| Bulk Density | 0.5 –0.7 | g/cm3 | Ph. EUR |
| Melting Point | 75 –78 | °C | Ph. EUR |
| Loss on Drying | max. 0.5 | % | Ph. EUR |
| Sulphated Ash | max. 0.1 | % | Ph. EUR |
| Assay | 98.5 to 101.10 | % | Ph. EUR |
| Optical Rotation | - 0.05 to + 0.05 ° | — | Ph. EUR |
Table 2 of 3
3 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| TAMC | max. 1000 | CFU/g | Ph. EUR |
| TYMC | max. 100 | CFU/g | Ph. EUR |
| E. Coli | Absence in 1 g sample | — | Ph. EUR |
Table 3 of 3
2 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Elemental Impurities (Fe) | max. 1300 | ppm | Ph. EUR |
| Elemental Impurities (Cr) | max. 25 | ppm | Ph. EUR |
