Product Specification - Bromelain
|Product number:||BRO-01 - BRO-05|
|Source:||Stem of pineapple (Ananas comosus (L.) MERR.)|
|Systematic name:||Peptidyl peptide hydrolase; EC 18.104.22.168|
|Other names:||Bromelin, Ananase.|
|Molecular weight:||33,200 daltons|
|GDU units/g||2500 - 3000||2000||1600||1200||80 - 1000|
|≈ FIP units/mg||5.0 - 6.0||4.0||3.2||2.4||0.16 - 2.0|
|Appearance:||Cream-colored to light greyish, odourless amorphous, hygroscopic powder|
|Identification’s Test||Skim milk reaction|
|Particle Size (mesh): Sieve test
(Ph. Eur. 2.9.12)
|70 - 80||60|
|Bulk density (kg/Litre):
(Ph. Eur. 2.9.15)
|Solubility (1 Aqua): (Ph. Eur. 2.2.1)||Partly soluble in water; insoluble in organic solvent|
|pH (1% Aqua): (Ph. Eur. 2.2.3)||3.5 to 5.5|
|Loss on drying: (Ph. Eur., 2.2.32)||< 5% at 60 °C, 4 h and 0.7 kPa|
|Residue on Ignition: (Ph. Eur., 2.4.14)||< 6%|
|Microbiological quality||according to current European Pharmacopoeia (5.1.4, 2.6.12 & 2.6.13)|
|Total viable aerobic
|Total combined yeast/moulds
|Bile-tolerant gram-negative bacteria||<102/g|
Maltodextrin Ph. Eur. (GMO-free) % (m/m)
|≤ 25 %||≤ 45 %||≤ 55 %||≤ 65 %||80 % - 97 %|
Further quality requirements:
Residual Solvents: according to:
1. current Ph. Eur. 5.4. & 2.4.24. by GC, 2. CPMP/QWP/450/03 corr. and EMEA/CVMP/511/03 annexes to CPMP/ICH/283/95 (International Conference on Harmonisation; Guidance on Impurities) No Solvents from groups 1, 2 and 3.
Bromelain complies with the Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (EMEA/410/01-Rev.1) in line with 2001/82/EC and 2001/83/EC (Ph. Eur. 5.2.8.). Bromelain has not been manufactured from a raw material of origins with TSE/BSE-Risk. It does not contain compounds manufactured from a raw material of origins with TSE/BSE-Risk.
Bromelain complies with the level of contamination for GMO according to 2003/1830/EU and 2003/1829/EU. Bromelain has not been manufactured from a raw material of genetically modified origin and does not contain compounds manufactured from other GMO products and their Derivatives.
Bromelain complies with the COMMISSION DIRECTIVE 2006/142/EC of 22 December 2006 amending Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council listing the ingredients which must under all circumstances appear on the labelling of foodstuffs. Bromelain does not contain allergens listed in Annex IIIa of EU Directive.