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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
| 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 | ||
| 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' - external site 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