Ibuprofen DC100

Ibuprofen DC100 is pelletized ibuprofen consisting of 100% pure active without additional excipients. The high concentration of API provides maximum freedom in formulation of dosage forms e.g. tablet size and release characteristics to achieve better patients’ compliance. Complex Ibuprofen formulations resulting from the critical compression behavior of the drug can be easily substituted using the 100 % active granules keeping the registered composition in the outer phase.

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Ibuprofen DC100 Cellets by ingredientpharm-2

Your benefits

100% pure active for easy formulations.

0% additional excipients
Controlled pellet size
GMP quality made in Germany
Simplifying drug formulations
Substitutes risks and critical compression behavior of Ibuprofen granules
Economic solution: cost & time saving
Unlimited scalability

Ibuprofen DC100 - Flow chart process 1 - ingredientpharm

Formulation without Ibuprofen DC 100 undergo further process steps, increasing uncertainity, risk of failure, and process time.

Ibuprofen DC100 - Flow chart process 2 - ingredientpharm

Formulation with Ibuprofen DC 100 minimzes process steps, increasing optimizing process time, and formulation safety.

Technical specification

DESCRIPTION			Test method
Appearance	White or nearly white particles		visual
Solubility	Practically insoluble in water, freely soluble in acetone, in methanol and in methylene chloride; it dissolves in dilute solutions of alkali hydroxides and carbonates		informative
Physical Parameters
Particle size distribution	≥ 75 % 200 – 500 μm		Ph. Eur.
Bulk density	0.5 – 0.7 g/ml (for information only)		Ph. Eur.
IDENTIFICATION
A Melting point	75 – 78 °C		Ph. Eur.
C Infrared Absorption	IR-spectrum equivalent reference standard		Ph. Eur.
CHEMICAL PARAMETERS
Appearance of solution	Clear and colorless		Ph. Eur.
Optical rotation	– 0.05 to + 0.05 °		Ph. Eur.
Related Substances	Specified impurities^*	J, A, N ≤ 0.15 %	Ph. Eur.
	Other detectable impurities	B, D, E, K, L, M ≤ 0.05 %	Ph. Eur.
	Unspecified impurities	≤ 0.05 % for all unidentified peaks	Ph. Eur.
	Total impurities	≤ 0.2 % (Peaks < 0.03 % are disregarded)	Ph. Eur.
Elemental Impurities	Fe ≤ 1300 ppm, Cr ≤ 25 ppm		Ph. Eur.
Loss on drying	≤ 0.5 %		Ph. Eur.
Sulphated ash	≤ 0.1 %		Ph. Eur.
Assay	98.5 to 101.0 %		Ph. Eur.
Residual solvents	Acetone	≤ 100 ppm	Ph. Eur.
	Hexane	≤ 290 ppm
	Isopropyl alcohol (IPA)	≤ 250 ppm
	Trichloroethylene	≤ 80 ppm
	Methanol^**	≤ 500 ppm
MICROBIOLOGICAL QUALITY
TAMC	≤ 10³ CFU/g		Ph. Eur.
TYMC	≤ 10² CFU/g		Ph. Eur.
E.coli	absence in 1 g sample		Ph. Eur.

^* The starting material Ibuprofen Ph. Eur. for Ibuprofen DC100 does not contain the impurity F.

^** Not used in the process, test included for compliance with certificate of suitability.

Organic solvents in accordance to Ph. Eur., 5.4 and USP <467> (CPMP/ICH/283/95) are not used neither by manufacturing of Ibuprofen DC100 nor by cleaning of equipment.

The starting material of Ibuprofen DC100 is exclusively of synthetic origin. A contamination with animal material by manufacturing, storage or shipment in the original closed containers will not occur. Therefore, Ibuprofen DC100 is free from Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE). Ibuprofen DC100 complies with the requirements of EMA/410/01 rev.3.