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Compositional guideline: Amylase

11 October 2012

Name of the ingredient

Amylase derived from Aspergillus oryzae (ABN)

Definition of the ingredient

Amylase (1,4-α-D-glucan glucanohydrolase) is an enzyme that is commercially derived from the fungus, Aspergillus oryza, via a fermentation process. During the recovery phase of production, manufacturers destroy A. oryzae before removing the non-proteinaceous material away from amylase. Amylase recovered from the fermentation broth is usually present in an aqueous solution or processed to a dried state.

CAS No. 9000-90-2

EC No. 3.2.1.1

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Liquid or powder
Identification
Amylase activity FCC Complies
Assay
Amylase activity FCC No less than 85.0% but no more than 115.0% of the declared activity expressed as DU*
Notes: * DU = alpha - amylase dextrinising unit
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Incidental metals and non-metals
Total heavy metals (as lead) FCC No more than 30 ppm
Lead FCC No more than 5 ppm
Other organic or inorganic impurities or toxins
Mycotoxins and aflatoxins FCC, AOAC Not detected
Antibiotic activity JECFA Not detected
Microbiology
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product which contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order.

Key to abbreviations

AOAC = Association of Analytical Communities Official Methods of Analysis 16th Ed. AOAC

BP = British Pharmacopoeia

FCC = Food Chemicals Codex

JECFA = Joint FAO/ WHO Expert Committee on Food Additives in FAO Food and Nutrition Paper No.52 (Addendum 9)

Ph Eur = European Pharmacopoeia