{"id":364352,"date":"2024-10-20T01:50:11","date_gmt":"2024-10-20T01:50:11","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-cen-tr-176122021\/"},"modified":"2024-10-26T02:54:45","modified_gmt":"2024-10-26T02:54:45","slug":"bsi-pd-cen-tr-176122021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-cen-tr-176122021\/","title":{"rendered":"BSI PD CEN\/TR 17612:2021"},"content":{"rendered":"

This document gives an overview of recommendations on product specifications, and other relevant information, for algae and algae products for pharmaceutical applications.<\/p>\n

This document does not apply to food and feed applications.<\/p>\n

This document does not provide instructions on handling of technical requirements in existing legislations.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
8<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n4 Product characteristics
4.1 Product purity
4.1.1 General <\/td>\n<\/tr>\n
11<\/td>\n4.1.2 Purity of microalgae and cyanobacteria
4.1.3 Purity of macroalgae <\/td>\n<\/tr>\n
12<\/td>\n4.1.4 Purity of algae derivatives or extracts <\/td>\n<\/tr>\n
13<\/td>\n4.1.5 Methods of analysis <\/td>\n<\/tr>\n
14<\/td>\n4.2 Contamination
4.2.1 General
4.2.2 Physical, biological and chemical contaminants
4.2.3 Microbiological quality of algae and algae biomass <\/td>\n<\/tr>\n
15<\/td>\n4.2.4 Contaminants in algae and algal pharmaceutical ingredients
4.2.4.1 General
4.2.4.2 Heavy metals <\/td>\n<\/tr>\n
16<\/td>\n4.2.4.3 Dioxins and related xenobiotes
4.2.4.4 PAHs
4.2.4.5 Uranium
4.2.4.6 Iodine <\/td>\n<\/tr>\n
17<\/td>\n4.2.4.7 Pesticide residues
4.2.4.8 Residual solvents <\/td>\n<\/tr>\n
18<\/td>\n4.3 Other product characteristics
4.3.1 Identification
4.3.2 Particle size
4.3.3 Foreign matter <\/td>\n<\/tr>\n
19<\/td>\n4.3.4 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) <\/td>\n<\/tr>\n
20<\/td>\n4.3.10 Assay
5 Storage
6 Labelling <\/td>\n<\/tr>\n
21<\/td>\n7 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 <\/td>\n<\/tr>\n
22<\/td>\n7.5 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. <\/td>\n<\/tr>\n
23<\/td>\n8.4 Sustainable development of microalgae production
9 Traceability
9.1 General <\/td>\n<\/tr>\n
24<\/td>\n9.2 Chain of Custody
10 Algae in EP and USP General Monographs <\/td>\n<\/tr>\n
25<\/td>\nAnnex A (informative)Regulatory framework
A.1 Regulatory framework in UE
A.2 Regulatory framework outside UE <\/td>\n<\/tr>\n
26<\/td>\nAnnex B (informative)Raw Material Specifications examples
B.1 Example of cyanobacterium biomass Specifications (Spirulina monograph) <\/td>\n<\/tr>\n
27<\/td>\nB.2 Example of seaweed biomass Specifications (Fucus monograph) <\/td>\n<\/tr>\n
29<\/td>\nAnnex C (informative)Technical Data Sheets (TDS) examples <\/td>\n<\/tr>\n
32<\/td>\nAnnex D (informative)Origin of algae products
D.1 Origin of algae strains
D.2 Origin of algae products <\/td>\n<\/tr>\n
34<\/td>\nD.3 Origin Statement <\/td>\n<\/tr>\n
35<\/td>\nAnnex E (informative)Algae extracts
E.1 Algae extracts for pharmaceutical purposes
E.2 Solvent properties <\/td>\n<\/tr>\n
36<\/td>\nE.3 Solvent extraction vs CO2-Extraction
E.4 Algae biomass CO2-Extraction <\/td>\n<\/tr>\n
38<\/td>\nAnnex F (informative)Purity identification methods and gap analysis algae <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Algae and algae products. Specifications for pharmaceutical sector applications<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":364357,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[189,2641],"product_tag":[],"class_list":{"0":"post-364352","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-13-020-55","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/364352","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/364357"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=364352"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=364352"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=364352"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}