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Vaccine manufacturing 1.3 Other ingredients Formaldehyde Inactivating ingredients - to kill viruses or inactivate toxins 291211 OECD, WCO 34 1. (...) Vaccine manufacturing 1.3 Other ingredients Monobasic potassium phosphate 283524 Assumed pure. (...) Vaccine manufacturing 1.3 Other ingredients Emulsifiers Emulsification - To help the water and oil based ingredients stay together More information is needed for classification ADB 40 1.
Language:English
Score: 1031907.7 - https://www.wto.org/english/tr..._e/vaccine_inputs_report_e.pdf
Data Source: un
The calculations are presented here in full, for clarity, but can be simplified by omitting the term for relative hazard of the active ingredient (=1). Calculations (i) Calculate the relative hazard of the impurity (RelHazimp) from the hazard data for the impurity (Hazimp) and active ingredient (Hazai). The term Haz expresses the toxicity in a figure that is inversely related to the potency, such as LD50, NOAEL, BMD or BMDL, imp ai imp Haz Haz lHaz Re = (i) ‡ The relative hazard of the active ingredient (RelHazai) is consequently 1. (ii) Calculate the maximum theoretical increase in hazard of the active ingredient/impurity mixture (MTIHaz), as a proportion of active ingredient hazard (Hazai), from the minimum purity (%) of the TC (%aimin) and the corresponding theoretical maximum content (%) of the impurity (%impmax). ai min imp max ai min lHaz Re ai % ) lHaz Re imp (% ) lHaz Re ai (% MTIHaz ´ ´ + ´ = The expression may be simplified because RelHazai = 1. min imp max min ai % ) lHaz Re imp (% ai % MTIHaz ´ + = (ii) ‡ (iii) Calculate the maximum limit acceptable for the impurity concentration (%impmaxaccept) by substituting a limit of 1.1 (i.e. +10%) for MTIHaz and %impmaxaccept for %impmax, in equation (ii): min imp accept max min ai % ) lHaz Re imp (% ai % . ´ + = 1 1 (iii) ‡ and rearranging equation (iii): imp min accept max lHaz Re ai % . imp % ´ = 1 0 (iv) ‡Where: Hazai = active ingredient hazard value; Hazimp = impurity hazard value; RelHazimp = relative hazard of impurity compared with active ingredient; RelHazai = relative hazard of active ingredient (=1); %aimin = declared minimum active ingredient content; %impmax = maximum theoretical content of impurity; MTIHaz = maximum theoretical increase in hazard due to impurity; %impmaxaccept = maximum acceptable content of impurity. (...) The acute oral LD50 of an impurity is 2000 mg/kg bw and that of the active ingredient is 1000 mg/kg bw. That is, the impurity is less hazardous than the active ingredient. 5 . 0 2000 1000 Re = = imp lHaz ‡ Calculate MTIHaz from equation ii. 0 3 20 5 0 80 20 . ) . ( MTIHaz = ´ + = (200% >10% increase, therefore the impurity is relevant ) ‡ Calculate %impmaxaccept from equation iv. % . . imp % accept max 4 5 0 20 1 0 = ´ = ‡ Example 3 The acute oral LD50s of an impurity and active ingredient are 400 and 600 mg/kg bw, respectively, and the minimum purity of the TC is 98%. 5 . 1 400 600 Re = = imp lHaz ‡ Calculate MTIHaz from equation ii. 03 1 98 5 1 2 98 . ) . ( MTIHaz = ´ + = (3% <10% increase, therefore the impurity is non-relevant ). ‡ _1328179299.unknown _1328179728.unknown _1328180302.unknown _1328180475.unknown _1328180932.unknown _1328180006.unknown _1328179634.unknown _1328178071.unknown _1328178808.unknown _1323848652.unknown _1323849569.unknown _1323850077.unknown _1323848212.unknown
Language:English
Score: 1030670.3 - https://www.fao.org/fileadmin/...s/Specs/JMPS_Manual/LETACC.doc
Data Source: un
Meanwhile, demand for wild plant ingredients keeps growing, especially in wealthier countries. (...) Baobab powder is used as a food and beverage ingredient, while its seed oil is used as a cosmetic ingredient. (...) Its berries are a key ingredient in gin manufacturing. They are also used as a food flavouring, an essential oil, an ingredient in cosmetics, and have a long history of use in traditional medicines and for religious purposes.
Language:English
Score: 1027222.4 - https://www.fao.org/newsroom/d...ients-vulnerable-plants-fao/en
Data Source: un
(b) Where an ingredient of the foodstuff is itself the product of several ingredients, the latter shall be regarded as ingredients of the foodstuff in question. (...) The quantity indicated, expressed as a percentage, shall correspond to the quantity of the ingredient or ingredients at the time of its/their use. (...) The indication referred to in paragraph 1 shall appear either in or immediately next to the name under which the foodstuff is sold or in the list of ingredients in connection with the ingredient or category of ingredients in question. 6.
Language:English
Score: 1023371.2 - https://www.fao.org/uploads/media/EU_2000_13_EC.pdf
Data Source: un
Vaccine manufacturing 1.3 Other ingredients Formaldehyde Inactivating ingredients - to kill viruses or inactivate toxins 291211 OECD, WCO 34 1. (...) Vaccine manufacturing 1.3 Other ingredients Monobasic potassium phosphate 283524 Assumed pure. (...) Vaccine manufacturing 1.3 Other ingredients Emulsifiers Emulsification - To help the water and oil based ingredients stay together More information is needed for classification ADB 41 1.
Language:English
Score: 1022656.8 - https://www.wto.org/english/tr...cine_inputs_report_jun22_e.pdf
Data Source: un
Clauses for free active ingredient content and release rate of the active ingredient are required only for the encapsulated active ingredient(s) and only if appropriate to the intended properties of the capsules. (...) A clause to control free active ingredient is usually required where encapsulation is intended to control the release or stability of the active ingredient, or to decrease the risk to users from accidental exposure to the active ingredient. If more than one active ingredient is encapsulated, limits must be provided for each.
Language:English
Score: 1018458.6 - https://www.fao.org/fileadmin/...des/Specs/JMPS_Manual/7.43.doc
Data Source: un
The similarity of the active ingredient, including its impurities           ii. The concentration of the active ingredient and any relevant impurities           iii. (...) As a result, the hazards of the two active ingredients will be the same.   Alternatively, the active ingredients can also be equivalent , which means that the relevant impurities (and associated hazards) will not differ significantly.   (...) ii. Active ingredient concentration If the concentrations of the active ingredient(s) in the two products that are bridged are the same, bridging is facilitated.  
Language:English
Score: 1014107.6 - https://www.fao.org/pesticide-...are-the-pesticide-products/fr/
Data Source: un
The similarity of the active ingredient, including its impurities           ii. The concentration of the active ingredient and any relevant impurities           iii. (...) As a result, the hazards of the two active ingredients will be the same.   Alternatively, the active ingredients can also be equivalent , which means that the relevant impurities (and associated hazards) will not differ significantly.   (...) ii. Active ingredient concentration If the concentrations of the active ingredient(s) in the two products that are bridged are the same, bridging is facilitated.  
Language:English
Score: 1014107.6 - https://www.fao.org/pesticide-...are-the-pesticide-products/zh/
Data Source: un
The similarity of the active ingredient, including its impurities           ii. The concentration of the active ingredient and any relevant impurities           iii. (...) As a result, the hazards of the two active ingredients will be the same.   Alternatively, the active ingredients can also be equivalent , which means that the relevant impurities (and associated hazards) will not differ significantly.   (...) ii. Active ingredient concentration If the concentrations of the active ingredient(s) in the two products that are bridged are the same, bridging is facilitated.  
Language:English
Score: 1014107.6 - https://www.fao.org/pesticide-...are-the-pesticide-products/ar/
Data Source: un
The similarity of the active ingredient, including its impurities           ii. The concentration of the active ingredient and any relevant impurities           iii. (...) As a result, the hazards of the two active ingredients will be the same.   Alternatively, the active ingredients can also be equivalent , which means that the relevant impurities (and associated hazards) will not differ significantly.   (...) ii. Active ingredient concentration If the concentrations of the active ingredient(s) in the two products that are bridged are the same, bridging is facilitated.  
Language:English
Score: 1014107.6 - https://www.fao.org/pesticide-...are-the-pesticide-products/en/
Data Source: un