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BSI PD CEN/TR 17612:2021

BSI PD CEN/TR 17612:2021

$167.15

Algae and algae products. Specifications for pharmaceutical sector applications

Published By Publication Date Number of Pages
BSI 2021 42
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This document gives an overview of recommendations on product specifications, and other relevant information, for algae and algae products for pharmaceutical applications.

This document does not apply to food and feed applications.

This document does not provide instructions on handling of technical requirements in existing legislations.

PDF Catalog

PDF Pages PDF Title
2 undefined
8 1 Scope
2 Normative references
3 Terms and definitions
10 4 Product characteristics
4.1 Product purity
4.1.1 General
11 4.1.2 Purity of microalgae and cyanobacteria
4.1.3 Purity of macroalgae
12 4.1.4 Purity of algae derivatives or extracts
13 4.1.5 Methods of analysis
14 4.2 Contamination
4.2.1 General
4.2.2 Physical, biological and chemical contaminants
4.2.3 Microbiological quality of algae and algae biomass
15 4.2.4 Contaminants in algae and algal pharmaceutical ingredients
4.2.4.1 General
4.2.4.2 Heavy metals
16 4.2.4.3 Dioxins and related xenobiotes
4.2.4.4 PAHs
4.2.4.5 Uranium
4.2.4.6 Iodine
17 4.2.4.7 Pesticide residues
4.2.4.8 Residual solvents
18 4.3 Other product characteristics
4.3.1 Identification
4.3.2 Particle size
4.3.3 Foreign matter
19 4.3.4 Total ash, insoluble ash
4.3.5 Extractable matter
4.3.6 Swelling index
4.3.7 Bitterness value
4.3.8 Loss on drying
4.3.9 Water (for herbal drugs with high essential oil content)
20 4.3.10 Assay
5 Storage
6 Labelling
21 7 Product information documents
7.1 General
7.2 Material Safety Data Sheet
7.3 Other relevant product information
7.3.1 Origin
7.3.2 Strain origin
7.3.3 Product origin
7.4 Protected species
22 7.5 Algae extracts
8 Sustainable development
8.1 General
8.2 United Nations sustainable development goals
8.3 Macroalgae biomass can be supplied by harvesting of wild stocks or aquaculture.
23 8.4 Sustainable development of microalgae production
9 Traceability
9.1 General
24 9.2 Chain of Custody
10 Algae in EP and USP General Monographs
25 Annex A (informative)Regulatory framework
A.1 Regulatory framework in UE
A.2 Regulatory framework outside UE
26 Annex B (informative)Raw Material Specifications examples
B.1 Example of cyanobacterium biomass Specifications (Spirulina monograph)
27 B.2 Example of seaweed biomass Specifications (Fucus monograph)
29 Annex C (informative)Technical Data Sheets (TDS) examples
32 Annex D (informative)Origin of algae products
D.1 Origin of algae strains
D.2 Origin of algae products
34 D.3 Origin Statement
35 Annex E (informative)Algae extracts
E.1 Algae extracts for pharmaceutical purposes
E.2 Solvent properties
36 E.3 Solvent extraction vs CO2-Extraction
E.4 Algae biomass CO2-Extraction
38 Annex F (informative)Purity identification methods and gap analysis algae

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BSI PD CEN/TR 17612:2021
$167.15