IBUPROFEN DC-100

1 of 1 products in this brand

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.

Chemical Name: Ibuprofen

CAS Number: 15687-27-1

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), United States Pharmacopeia (USP)

Dosage Form: Orally Disintegrating Tablets (ODTs), Tablets

Labeling Claims: BSE-free, TSE-free

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

Technical Data Sheet Safety Data Sheet

Knowde Enhanced TDS

Identification & Functionality

Chemical Name: Ibuprofen
Pharma & Nutraceuticals Functions: Anti-Inflammatory,
Pain Reliever
CAS No.: 15687-27-1
EC No.: 239-784-6
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors
Active Pharmaceutical Ingredients (APIs)

Features & Benefits

Labeling Claims: BSE-free,
TSE-free
Features: Direct compression

High speed tableting

Higher productivity

Taste masking

ODT and modified release

High drug load

Smaller tablets
Benefits: Ibuprofen DC 100 consists of 100% pure, specifically shaped Ibuprofen. It does not show sticking and picking behavior in high speed tableting
High Performance API: 100% Ibuprofen pellets for Direct Compression and coating processes for taste masking (OTD) & extended release formular

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Orally Disintegrating Tablets (ODTs),
Tablets
Manufacturing Technology: Direct Compression
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.

Properties

Physical Form: Granules,
Solid,
Spheres
Appearance: White or nearly white particles
Physico-Chemical Properties
Microbiological Values
Composition

	Value	Units	Test Method / Conditions
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

	Value	Units	Test Method / Conditions
TAMC	max. 1000	CFU/g	Ph. EUR
TYMC	max. 100	CFU/g	Ph. EUR
E. Coli	Absence in 1 g sample	—	Ph. EUR

	Value	Units	Test Method / Conditions
Elemental Impurities (Fe)	max. 1300	ppm	Ph. EUR
Elemental Impurities (Cr)	max. 25	ppm	Ph. EUR

Regulatory & Compliance

Certifications & Compliance: European Pharmacopeia (Ph. Eur.),
United States Pharmacopeia (USP)
Grade: Pharma Grade

IBUPROFEN DC-100

Similar Products

Ibuprofen 25

Ibuprofen 38

Ibuprofen 50

Ibuprofen 70

Ibuprofen DC 85 W

BTC Europe GmbH Ibuprofen 25

Knowde Enhanced TDS