#294868
"(ina bhfuil ≥ xx % eisíontais)".
"(containing ≥ xx % impurity)".
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#1735749
méid an eisíontais,
degree of impurity,
#1911923
Ní mar thoradh ar theagmhais neamhthuartha a eascraíonn le linn na monaraíochta e.g. eisíontas neamhcháilithe nua, a dhéanfar an t-athrú; athruithe ar theorainneacha iomlána eisíontais.
The change shall not result from unexpected events arising during manufacture e.g. new unqualified impurity; change in total impurity limits.
#1911932
Ní mar thoradh ar theagmhais neamhthuartha a eascraíonn le linn na monaraíochta (e.g. eisíontas neamhcháilithe nua nó athrú ar theorainneacha iomlána eisíontais).
The change shall not result from unexpected events arising during manufacture (e.g. new unqualified impurity or change in total impurity limits).
#1911940
Ní le heisíontas géineatocsaineach a bhainfidh an t-athrú.
The change shall not concern a genotoxic impurity.
#1912062
Ní mar thoradh ar theagmhais neamhthuartha a eascraíonn le linn na monaraíochta e.g. eisíontas neamhcháilithe nua nó athrú ar theorainneacha iomlána eisíontais.
The change shall not be a result of unexpected events arising during manufacture, e.g. new unqualified impurity or change in total impurity limits.
#1912070
Ní mar thoradh ar theagmhais neamhthuartha a eascraíonn le linn na monaraíochta e.g. eisíontas neamhcháilithe nua nó athrú ar theorainneacha iomlána eisíontais.
The change shall not result from unexpected events arising during manufacture, e.g. new unqualified impurity or change in total impurity limits.
#2050085
i. méid an eisíontais;
degree of impurity;
#2069328
An t-eisíontas nicitín, ní rachaidh sé thar na luachanna seo a leanas san ábhar teicniúil:
The impurity nicotine shall not exceed the following values in the technical material:
#2186061
ag a bhfuil cóimheas eisíontais is lú ná 1,2 mg/PCS,
an impurity ratio of less than 1,2 mg/PCS,
#2474247
Ni mór Beinsifeanón mar eisíontas agus/nó mar tháirge díghrádúcháin d’Ochtaicriléin a choinneáil ar an rianleibhéal.”
Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.’
#2512246
ciallaíonn ‘eisíontas ábhartha’ eisíontas ceimiceach arb údar imní é do shláinte an duine, do shláinte ainmhithe nó don chomhshaol;
‘relevant impurity’ means a chemical impurity that is of concern for human health, animal health or the environment;
#2512890
ciallaíonn ‘eisíontas ábhartha’ eisíontas ceimiceach arb údar imní é do shláinte an duine, do shláinte ainmhithe nó don chomhshaol;
“relevant impurity” means a chemical impurity that is of concern for human health, animal health or the environment;
#2513549
ciallaíonn ‘eisíontas ábhartha’ eisíontas ceimiceach arb údar imní é do shláinte an duine, do shláinte ainmhithe nó don chomhshaol;
‘relevant impurity’ means a chemical impurity that is of concern for human health, animal health or the environment;
#2516634
Gan eisíontas ábhartha
No relevant impurity
#2610102
ag a bhfuil cóimheas eisíontais is lú ná 1,2 mg/PCS,
an impurity ratio of less than 1,2 mg/PCS,
#3123852
Eisíontas D: ≤ 0,1 %.
Impurity D: ≤ 0,1 %.
#3123853
Aon eisíontas aonair eile: ≤ 0,5 %.
Any other single impurity: ≤ 0,5 %.
#3136041
Uaschéatadán an eisíontais (Schwarzbesatz)
Maximum impurity percentage (Schwarzbesatz)
#3136049
Uaschéatadán an eisíontais
Maximum impurity percentage
#3148179
ag a bhfuil cóimheas eisíontais is lú ná 1,2 mg/PCS,
an impurity ratio of less than 1,2 mg/PCS,
#3191399
sárocsadhéshulfáit déphotaisiam (eisíontas ábhartha): ≤ 20 g/kg (≤ 2 % w/w)
dipotassium peroxydisulphate (relevant impurity): ≤ 20 g/kg (≤ 2 % w/w)
#1073910
—(1) I ngach monarcha ina mbeidh á chur amach, i ndáil le haon phróis a bheas ar siúl, an oiread sin agus an saghas sin deannaigh nó múiche nó eisíonachta de shórt eile gur dócha go ndéanfadh sé díobháil do na daoine a fostaítear nó go mba chol leo é, nó aon mhéid mór deannaigh d'aon chineál, déanfar gach beart is féidir chun na daoine a fostaítear a chosaint ar an deannach nó an múch nó an eisíonacht eile a análú isteach agus chun é a chosc ó charnadh in aon tseomra oibre, agus go háirithe, más próis í inar féidir sin, déanfar scéidh-fhearais a chur ar fáil agus a chothabháil chomh comhgarach agus is féidir do láthair tuismithe an deannaigh, na múiche nó na heisíonachta eile, ionas nach ligfear san aer é in aon tseomra oibre.
—(1) In every factory in which, in connection with any process carried on, there is given off any dust or fume or other impurity of such a character and to such an extent as to be likely to be injurious or offensive to the persons employed, or any substantial quantity of dust of any kind, all practicable measures shall be taken to protect the persons employed against inhalation of the dust or fume or other impurity and to prevent its accumulation in any workroom, and in particular, where the nature of the process makes it practicable, exhaust appliances shall be provided and maintained, as near as possible to the point of origin of the dust or fume or other impurity, so as to prevent it entering the air of any workroom.
#1359186
I ngach monarcha ina mbeidh á chur amach, i ndáil le haon phróis a bheas ar siúl, an oiread sin agus an saghas sin deannaigh nó múiche nó eisíonachta de shórt eile gur dócha go ndéanfadh sé díobháil do na daoine a fostaítear nó a oibríonn san áitreabh nó go mba chol leo é, nó aon mhéid mór deannaigh d'aon chineál, déanfar gach beart is féidir chun na daoine sin a chosaint ar an deannach nó an múch nó an eisíonacht eile a análú isteach agus chun é a chosc ó charnadh in aon tseomra oibre, agus go háirithe, más próis í inar féidir sin, déanfar scéidh-fhearais a chur ar fáil agus a chothabháil chomh comhgarach agus is féidir do láthair tuismithe an deannaigh, na múiche nó na heisíonachta eile, ionas nach ligfear san aer é in aon tseomra oibre.
In every factory in which, in connection with any process carried on, there is given off any dust or fume or other impurity of such a character and to such an extent as to be likely to be injurious or offensive to the persons employed or working on the premises, or any substantial quantity of dust of any kind, all practicable measures shall be taken to protect those persons against inhalation of the dust or fume or other impurity and to prevent its accumulation in any workroom, and in particular, where the nature of the process makes it practicable, exhaust appliances shall be provided and maintained, as near as possible to the point of origin of the dust or fume or other impurity, so as to prevent it entering the air of any workroom.
#291864
1. I gcás ina mbeidh i substaint substaint eile a aicmítear mar shubstaint ghuaiseach, cibé acu i bhfoirm eisíontais shainaitheanta, breiseáin shainaitheanta nó comhábhair leithligh shainaitheanta, cuirfear é seo san áireamh chun críocha an aicmithe más rud é go mbeidh tiúchan an eisíontais shainaitheanta, an bhreiseáin shainaitheanta nó an chomhábhair leithligh shainaitheanta ar cóimhéid leis an luach scoite is infheidhme i gcomhréir le mír 3 nó níos mó ná é.
1. Where a substance contains another substance, itself classified as hazardous, whether in the form of an identified impurity, additive or individual constituent, this shall be taken into account for the purposes of classification, if the concentration of the identified impurity, additive or individual constituent is equal to, or greater than, the applicable cut-off value in accordance with paragraph 3.
#1941329
Sainaithníodh an t-eisíontas hiodraisín, ar ábhar tosaigh é, mar eisíontas ábhartha, le linn an mheasúnaithe, ós rud é gur aimsíodh é sna baisceanna plandaí píolótacha ar a ndearnadh athmheasúnú agus sna baisceanna plandaí ó na láithreáin tráchtála.
The impurity hydrazine, a starting material, has been identified during the assessment as a relevant impurity, since it was detected in the reanalysed pilot plant batches as well as in the commercial plant batches.
#1941330
Ag cur san áireamh go bhfuil an t-eisíontas ábhartha hiodraisín ina chúis imní ó thaobh na tocsaineolaíochta de, chinn an Coimisiún nár chóir go rachadh uasmhéid an eisíontais sin san ábhar teicniúil thar 0,0001 % (1 mg/kg).
Bearing in mind that the relevant impurity hydrazine is of toxicological concern, the Commission has concluded that a maximum content of this impurity in the technical material should not exceed 0,0001 % (1 mg/kg).
#2907626
I gcás substaintí srianta agus eisíontais dhosheachanta lena ngabhann aicmiú srianta, úsáidfear tiúchan na substainte srianta nó an eisíontais agus fachtóir coinneála toimhdithe de 100 % chun meastachán a dhéanamh ar chainníocht na substainte srianta nó an eisíontais atá sa táirge deiridh.
For restricted substances and unavoidable impurities with a restricted classification, the concentration of the restricted substance or impurity and an assumed retention factor of 100 % shall be used to estimate the quantity of the restricted substance or impurity remaining in the final product.
#2907640
I gcás eisíontais dhosheachanta a shainaithnítear mar shubstaintí ar ábhar mór imní iad, úsáidfear tiúchan an eisíontais agus fachtóir coinneála toimhdithe de 100 % chun meastachán a dhéanamh ar chainníocht an eisíontais ar ábhar mór imní é sa táirge deiridh.
For unavoidable impurities identified as SVHCs, the concentration of the impurity and an assumed retention factor of 100 %, shall be used to estimate the quantity of the SVHC impurity remaining in the final product.
#2908005
I gcás substaintí srianta agus eisíontais dhosheachanta lena ngabhann aicmiú srianta, úsáidfear tiúchan na substainte srianta nó an eisíontais agus fachtóir coinneála toimhdithe de 100 % chun meastachán a dhéanamh ar chainníocht na substainte srianta nó an eisíontais atá sa táirge deiridh.
For restricted substances and unavoidable impurities with a restricted classification, the concentration of the restricted substance or impurity and an assumed retention factor of 100 %, shall be used to estimate the quantity of the restricted substance or impurity remaining in the final product.
#170667
(c) Ní mheasfar gur neamhíonacht iomlán uasta 0.8% de réir meáchain de shíolta speicis Poa eile.
( c ) A maximum total of 0.8% by weight of seeds of other Poa species shall not be regarded as an impurity.
#170668
(d) Ní mheasfar gur neamhíonacht uasmhéid 1% de réir meáchain de shíolta Trifolium Pratense.
( d ) A maximum of 1% by weight of seeds of Trifolium pratense shall not be regarded as an impurity.
#170689
(a) Ní mheasfar gur neamhíonacht iomlán uasta 80 síol Poa spp.
( a ) A maximum total of 80 seeds of Poa spp. shall not be regarded as an impurity.
#170692
(c) Ní mheasfar gur neamhíonacht iomlán uasta 20 síol Poa spp.
( c ) A maximum total of 20 seeds of Poa spp. shall not be regarded as an impurity.
#170705
I gcás Poa annua ní mheasfar gur neamhíonacht iomlán uasta 10% de réir meáchain de shíolta de speicis Poa eile.
In Poa annua a maximum total of 10% by weight of seeds of other Poa species shall not be regarded as an impurity.
#170706
I gcás Poa spp. seachas Poa annua, ní mheasfar gur neamhíonacht iomlán uasta 3% de réir meáchain de shíolta speicis Poa eile.
In Poa spp. other than Poa annua a maximum total of 3% by weight of seeds of other Poa species shall not be regarded as an impurity.
#170707
I gcás Hedisarum coronarium ní mheasfar gur neamhíonacht uasta 1% de réir meáchain de shíolta Melilotus spp.
In Hedysarum coronarium a maximum total of 1% by weight of seeds of Melilotus spp. shall not be regarded as an impurity.
#170714
I gcás Vicia spp. ní mheasfar gur neamhíonacht líon uasta 6% de réir meáchain de shíolta Vicia pannonica, Vicia villosa nó speicis saothraithe gaolmhara i Speiceas iomchuí eile.
In Vicia spp. a maximum total of 6% by weight of seeds of Vicia pannonica, Vicia villosa or related cultivated species in another relevant species shall not be regarded as an impurity.
#179639
(b) Ní mheasfar gur neamh íonacht é an dara síol má bhíonn an dara sampla den mheáchan céanna saor ó aon síolta de speicis ghránach eile.
(b) A second seed shall not be regarded as an impurity if a second sample of same weight is free from any seeds of other cereals species.
#306858
2. ciallaíonn "substaintí" dúile ceimiceacha agus a gcomhdhúile, mar is ann dóibh go nádúrtha nó trí mhonarú, lena n-áirítear aon eisíontas a tharlaíonn mar thoradh dosheachanta ar phróiseas an mhonaraithe;
2. "substances" means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;
#307622
(b) sonraíocht eisíontas na substainte gníomhaí cé is moite de na heisíontais a mheastar a bheith ábhartha ó thaobh na tocsaineolaíochta, na héiceathocsaineolaíochta nó an chomhshaoil de;
(b) the specification of impurity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;
#641870
Léiriú a bheidh san ábhar tástála a úsáidfear i staidéir tocsaineolaíochta ar ábhar na trialach cliniciúla i dtéarmaí próifílí eisíontais cáilíochtúla agus cainníochtúla.
The test material used in toxicity studies shall be representative of that of the clinical trial use in terms of qualitative and quantitative impurity profiles.
#1653265
In 0C004, sainmhínítear ‘coibhéis bhóróin’ (CB) mar shuim CBz, d’eisíontas (seachas CBcarbón ós rud é nach meastar carbón mar eisíontas) lena n-áirítear bórón, sa chás seo a leanas:
In 0C004, ‘boron equivalent’ (BE) is defined as the sum of BEz for impurities (excluding BEcarbon since carbon is not considered an impurity) including boron, where:
#1748932
Nóta 2:In 0C004, sainmhínítear ‘coibhéis bóróin’ (CB) mar shuim CBz, d’eisíontas (seachas CBcarbón ós rud é nach meastar carbón mar eisíontas) lena náirítear bórón, sa chás seo a leanas:
Note 2:In 0C004, 'boron equivalent' (BE) is defined as the sum of BEz for impurities (excluding BEcarbon since carbon is not considered an impurity) including boron, where:
#1752114
2.Tá siad déanta nó comhdhéanta de na hábhair seo a leanas nó tá siad brataithe leo, agus leibhéal eisíonachta 2 % nó níos mó ag na hábhair sin de réir meáchain:
2.Made of or coated with any of the following materials, or combination of the following materials, having an overall impurity level of 2 % or less by weight:
#1911919
Leis an athrú seo ní spreagfar athrú díobhálach ar an bpróifíl eisíontais cáilíochtúil cainníochtúil, ar láidreacht ná ar airíonna fisiciceimiceacha na substaintí gníomhaí.
The change shall not provoke an adverse change in qualitative and quantitative impurity profile, potency or in physico-chemical properties of the active substance.
#1911950
Ní bheidh aon athrú ar na teorainneacha iomlána eislíontais; ní bhraithfear aon eisíontas neamhcháilithe nua.
There shall be no changes of the total impurity limits; no new unqualified impurities shall be detected.
#1911963
Beidh na támháin agus gach idirmheánach, imoibrí, catalaíoch, tuaslagóir, nó rialuithe le linn próisis fós i gcomhréir leis na sonraíochtaí formheasta (e.g. próifíl eisíontais cáilíochta nó cainníochta).
The excipients and all intermediates, reagents, catalysts, solvents or in-process controls shall still conform to the approved specifications (e.g. qualitative and quantitative impurity profile).
#1911971
Ní dhéanfar aon athrú díobhálach ar phróifíl eisíontais cáilíochta ná ar phróifíl eisíontais cainníochta ná ar airíonna fisiciceimiceacha.
There shall be no adverse change in qualitative and quantitative impurity profile or in physico-chemical properties.
#1911979
Ní bheidh aon athrú ar na teorainneacha iomlána eislíontais; ní bhraithfear aon eisíontas neamhcháilithe nua.
There shall be no changes to the total impurity limits; no new unqualified impurities shall be detected.