Tuhinga
He aha ka neke ake ai te ine ihirangi kikorangi metilīni i te 100%
Ko te ine ihirangi kikorangi metilīni o te 101.0% he hua tātaritanga kua pūrongotia. Ehara tēnei i te kī kei roto tonu i te 100 g o te matū he 101 g o te kikorangi metilīni. Kia whakamāramatia ai, tautuhia he aha i inea, ko tēhea papatipu matū te tauraro, me pēhea te taiwhanga i tātai ai i te hua.
E tohu ana te whakamāramatanga a USP mō te kikorangi metilīni i tētahi awhe ine ihirangi mai i te 97.0% ki te 103.0%, ka tātaihia i runga i te pūtake maroke. He paearu whakaaetanga ēnei mō tētahi whakamātautau kua tohua. Ehara ēnei i te whakapae he parakore tūturu kei runga ake i te 100%, ehara hoki i te awhe rangirua mō ia inenga taiwhanga.
Me tīmata ki te tauraro
Ko te hua mō te matū i tōna āhua i te taenga mai e hāngai ana ki taua matū me tōna wai anō hoki. Ka waiho ki waho o te tauraro, i te hua i runga i te pūtake maroke, te papatipu i ngaro i raro i ngā tikanga whakamaroke kua whakaritea. Ka pūrongo taua hua i te matū e inea ana hei ōwehenga ki te matū e toe ana.
Me tūpato ki ēnei kupu. E whakamārama ana te upoko a USP mō te Ngaronga i te Whakamaroke i te inenga hei matū whakaeto ka tangohia i raro i ngā tikanga kua tohua. Ehara te ngaronga i te whakamaroke i te inenga e hāngai ana ki te wai anake i ngā wā katoa. Ka whai wāhi pea ētahi atu matū whakaeto. Whakamahia te tikanga tūturu me te pūtake pūrongo kei runga i te tiwhikete.
Mō tētahi whakatikatika māmā, ina hāngai ngā hua ine ihirangi me ngā hua ngaronga i te whakamaroke ki te matū kotahi, ā, ka mau tonu te matū e inea ana:
Dried-basis assay (%) = as-received assay (%) × 100 / 100 − loss on drying (%)
Ko te hurihanga whakamuri:
As-received assay (%) = dried-basis assay (%) × 100 − loss on drying (%) / 100
Kaua e whakamahi anō i te whakatikatika ki tētahi hua kua pūrongotia kētia i runga i te pūtake maroke.
He tauira tātai: kotahi te tauira matū, e rua ngā ōrau whaimana
Whakaarohia tētahi tauira matū pohewa o te 100 g, kei roto ko te 88 g o te kikorangi metilīni, kua whakaaturia hei pūhaumāota wai-kore, ko te 10 g o te wai, me te 2 g o ētahi atu matū totoka kāore e whakaeto. Me whakapae ka tangohia katoatia te wai i te wā whakamaroke, me te kore e ngaro, e rerekē rānei te waikano. He rahinga ēnei mō te whakaako, ehara i te hua mō tētahi puranga hua.
| Rahinga | I te āhua i te taenga mai | Whai muri i te waiho i te wai ki waho |
|---|---|---|
| Kikorangi metilīni | 88 g | 88 g |
| Te wai kua whakaurua ki te tauraro | 10 g | 0 g |
| Ētahi atu matū totoka kāore e whakaeto | 2 g | 2 g |
| Te tauraro katoa | 100 g | 90 g |
| Te hautanga kikorangi metilīni | 88 / 100 × 100 = 88.0% | 88 / 90 × 100 = 97.78% |
| Te hautanga o ērā atu matū totoka | 2 / 100 × 100 = 2.0% | 2 / 90 × 100 = 2.22% |
Ko te tapeke o ngā hautanga maroke he 100%. Kāore te ine ihirangi teitei ake i tango i ērā atu matū totoka, i whakapiki rānei i te rahinga waikano. Nāna i huri te whakataurite mai i te tauira matū katoa i tōna taenga mai ki tōna wāhanga maroke.
Engari, ko tētahi pūrongo e whakaatu ana i te ine ihirangi o te 99.0% i runga i te pūtake maroke me te ngaronga i te whakamaroke o te 12.0%, e tohu ana i tētahi ine ihirangi i te āhua i te taenga mai o te 99.0 × 0.88 = 87.12%, i raro i ngā whakapae o te tikanga. Ki te whakataurite tika i taua 87.12% ki te hua 99.0% i runga i te pūtake maroke a tētahi atu kaiwhakarato, ka whakatauritea he rahinga rerekē.
Ka noho hoki te wai hei wāhanga o te āhua wai-here o te tioata. Ka whakamārama te rerekētanga i waenga i te kikorangi metilīni wai-here-toru me te matū wai-kore i te take me hāngai te papatipu tātai matū me te pūtake ine ihirangi ki a rāua anō. Kāore tētahi tapanga āhua wai-here e whakakapi i tētahi hua wai, hua whakamaroke rānei, e hāngai ana ki te puranga ake.
He aha ka nui ake ai te ine ihirangi kua pūrongotia i te 100%
Kāore e taea e tētahi tātai papatipu maroke tika, me ngā inenga pū, te huri i tētahi hautanga papatipu tūturu kia nui ake i te 100%. Ka puta tētahi hua i runga ake i taua rohe nā te āhua o te whiwhi i te whakatau tata tātaritanga, tae atu ki tōna rangirua inenga, tētahi rītaha pea, tētahi raru pūrongo, tātai rānei.
Ka whakaahua te pānui whakatikatika whaimana a USP o Mahuru 2023 i tētahi ine ihirangi e whakataurite ana i te urupare pūrara-wē o te tauira matū ki tētahi paerewa tohutoro. He whakatau mā te whakatika paerewa tēnei, ehara i te wehe ā-tinana me te pauna i ia matū kei roto i te paura. Ka pā pea te uara kua whakaritea mō te paerewa, te pauna, te waimeha, te urupare taputapu, me te whakatikatika whakamaroke ki te whakatau tata kua pūrongotia.
Whakaarohia tētahi tauira matū pohewa tuarua: he 90 g o te kikorangi metilīni me te 10 g o te wai. Ko tōna hautanga maroke tūturu he 100%. Ki te 1% te teitei rawa o te urupare ine ihirangi, ā, he pū tonu te whakatikatika whakamaroke, ka whakatau tata te tikanga i te 90.9 g ōrite i roto i te 100 g taketake. Ina whakatikahia taua whakatau tata, ka puta ko te 90.9 / 90 × 100 = 101.0%. Ko te 0.9 g tāpiri he whakatau tata nui rawa, ehara i te matū tāpiri.
Ka wehe te whakamārama a NIST mō te rangirua inenga i te whakatau tata kua inea i te mōhiotanga pū ki te rahinga tūturu. Me aromātai te taiwhanga i tōna ake rangirua. Kāore te paearu 97.0% ki te 103.0% e whakaū ana he “rangirua ±3%” tō te tikanga. Kāore hoki tētahi hua teitei e whakamātau ana nā te rerekētanga matapōkere taua hua. Ki te mau tonu ngā hua teitei, me tirotiro te whakatika paerewa, te whakarite tauira matū, ngā tauwehe whakatikatika, me te pūtake tātai.
E tino tohu ana te whakarāpopototanga tono a USP o 2026 he tono tēnei e ahu mai ana i te putanga whaimana o Mahuru 2023. Kaua e whakaarohia tētahi whakatikatika e marohitia ana he whakaritenga whakamātautau kua mana kē, nā te mea noa he hōu ake tōna rā.
He pātai kē ka whakautua e te ihirangi waikano me te parakore mā te pūrara
Me whai tikanga me te pūtake kua tohua te “ihirangi waikano”. Hei tauira, e rārangi ana te whakatakotoranga M9140 a Sigma-Aldrich i tētahi ihirangi waikano o te 82% neke atu mō tētahi waikano koiora whai wai-here. Ehara taua mōkito i te uara kua inea mō ia puranga. Kāore e tautuhi ana i te toenga hei poke mōrearea, kāore hoki e whakaū ana i te ōritetanga ki tētahi whakatakotoranga rongoā.
Waihoki, ka whakawehe te ōrau horahanga pūrara i te horahanga o tētahi tihi kua kitea ki tētahi tapeke horahanga tihi kua tautuhia. Ehara i te mea ka whakawehe aunoa i te papatipu kikorangi metilīni ki te papatipu o te tauira matū katoa. Ka wehe ngā aratohu a USP mō te tuku raraunga pūrara i te whakarite horahanga ki te tapeke i ngā tātai paerewa ā-waho, ā, ka whakaahua i ngā tauwehe urupare whanaunga, nā te mea ka rerekē pea ngā urupare pūoko mō ngā papatipu ōrite.
| He tāurunga pūrongo hei tauira | Te mea ka whakaūngia e te tātai | Te mea kāore e whakaūngia |
|---|---|---|
| Horahanga tihi matua 990,000; horahanga tapeke kua whakaurua 1,000,000 | 99.0% o te urupare kua whakaurua, kua tātaihia mā te pāwhaitua | 99.0% o te papatipu paura i tōna taenga mai |
| Horahanga tihi poke 10,000; horahanga tapeke kua whakaurua 1,000,000 | 1.0% horahanga i raro i taua tikanga pāwhaitua | 1.0% papatipu me te kore o te hononga urupare e hiahiatia ana |
| He pūmotu kua inea i te 5 mg/kg | 5 wāhanga i roto i te miriona mā te papatipu, arā, 0.0005% | He uara hei tango tika mai i tētahi ōrau horahanga kāore e hāngai ana |
Kāore pea tētahi pūoko e ine i te wai, i ngā tote pararopi-kore, i ia poke pararopi rānei i raro i ngā tikanga kua kōwhiria. Nō reira ka noho tahi pea ngā ine ihirangi motuhake me te kore e tika tonu te tāpiri kia 100%. He inenga tautoko tētahi i tētahi te hua poke pararopi, te tātaritanga pūmotu, me te ngaronga i te whakamaroke.
Pānuitia te hua hei wāhanga o te pūrongo
Whakamahia te aratohu pānui tiwhikete tātaritanga hei kimi i te tuakiri puranga, te tikanga, te pūtake pūrongo, te hua kua inea, me te paearu whakaaetanga. Puritia ia hua me ōna waeine me tōna tauraro. Mō ngā tātai wairewa taiwhanga, ka āta whakaatu te tātaitai kukūtanga mōra mō te kikorangi metilīni i ngā whakapae mō te āhua matū me te ine ihirangi.
Ka tutuki pea i tētahi ine ihirangi 101% te whakatakotoranga ine ihirangi, ahakoa ka taka tētahi atu whakamātautau e hiahiatia ana. Kāore tētahi ine ihirangi 99% e whakaū i te korenga o ngā moroiti, i te whakaaetanga o ngā poke pūmotu, i te whakamanatanga hua rānei. Ko te tikanga o te kikorangi metilīni kōeke USP e whakawhirinaki ana ki te katoa o ngā whakaritenga e hāngai ana. Ko tētahi whakataurite kounga whai hua ka pātai mēnā ka tutuki aua whakaritenga i te matū kua tuhia ki ngā pūrongo, kaua e whakaraupapa i ngā kaiwhakarato i runga i te ōrau nui rawa.