Isihloko
Kungani ukuhlolwa kokuqukethwe kwe-methylene blue kungabonisa ngaphezu kuka-100%
Umphumela wokuhlolwa kokuqukethwe kwe-methylene blue ongu-101.0% ungumphumela obikiwe wokuhlaziya. Awusho ukuthi u-100 g wento equkethwe ngempela u-101 g we-methylene blue. Ukuze uwuqonde, thola ukuthi yini elinganisiwe, ukuthi yisiphi isisindo sento esisetshenziswe njengedenominetha, nokuthi ilabhorethri iwubale kanjani umphumela.
Incazelo ye-USP ye-methylene blue ibeka ibanga lokuhlolwa kokuqukethwe elisuka ku-97.0% liye ku-103.0%, elibalwa ngokwesisekelo esomile. Lezi yimikhawulo yokwamukela imiphumela yokuhlolwa okucacisiwe. Akusona isimangalo sobumsulwa bangempela obungaphezu kuka-100%, futhi akulona ibanga lokungaqiniseki kwazo zonke izilinganiso zaselabhorethri.
Qala ngedenominetha
Umphumela wento njengoba yamukelwe ubhekisela entweni esesimweni eyamukelwe ikuso, kuhlanganise namanzi ayo. Umphumela ngokwesisekelo esomile awusifaki kudenominetha isisindo esilahlekile ngaphansi kwezimo zokomisa ezibekiwe. Ubika inani lesakhi esihlaziywayo uma liqhathaniswa nento esele.
La magama adinga ukuqondwa ngokucophelela. Isahluko se-USP sokulahleka kwesisindo lapho komiswa sichaza lesi silinganiso ngokwezinto ezihwamukayo ezisuswa ngaphansi kwezimo ezicacisiwe. Ukulahleka kwesisindo lapho komiswa akusho ngokuzenzakalela ukuthi kukalwa amanzi kuphela. Nezinye izinto ezihwamukayo zingaba nengxenye kulokho kulahleka. Sebenzisa indlela yangempela nesisekelo sokubika esisesitifiketini.
Ekulungiseni okulula, lapho imiphumela yokuhlolwa kokuqukethwe neyokulahleka kwesisindo lapho komiswa iphathelene nento efanayo futhi isakhi esihlaziywayo singalahleki:
Ukuhlolwa kokuqukethwe ngokwesisekelo esomile (%) = ukuhlolwa kokuqukethwe njengoba kwamukelwe (%) × 100 / 100 − ukulahleka kwesisindo lapho komiswa (%)
Ukuguqula kubuyelwe emuva kwenziwa kanje:
Ukuhlolwa kokuqukethwe njengoba kwamukelwe (%) = ukuhlolwa kokuqukethwe ngokwesisekelo esomile (%) × 100 − ukulahleka kwesisindo lapho komiswa (%) / 100
Ungaphinde wenze lokhu kulungisa kumphumela osuvele ubikiwe ngokwesisekelo esomile.
Isibonelo esinezibalo: isampula elilodwa, amaphesenti amabili avumelekile
Ake sithi isampula elicatshangelwayo elingu-100 g liqukethe u-88 g we-methylene blue, ovezwe njenge-chloride engenamanzi, u-10 g wamanzi, no-2 g wezinye izinto eziqinile ezingahwamuki. Thatha ngokuthi isigaba sokomisa sisusa amanzi kuphela ncamashi, ngaphandle kokulahlekelwa udayi noma ukuwuguqula. Lawa amanani okufundisa, hhayi imiphumela yeqoqo lomkhiqizo.
| Inani | Njengoba kwamukelwe | Ngemva kokungafaki amanzi |
|---|---|---|
| I-methylene blue | 88 g | 88 g |
| Amanzi afakiwe kudenominetha | 10 g | 0 g |
| Ezinye izinto eziqinile ezingahwamuki | 2 g | 2 g |
| Idenominetha ephelele | 100 g | 90 g |
| Ingxenye ye-methylene blue | 88 / 100 × 100 = 88.0% | 88 / 90 × 100 = 97.78% |
| Ingxenye yezinye izinto eziqinile | 2 / 100 × 100 = 2.0% | 2 / 90 × 100 = 2.22% |
Izingxenye ezomile zihlangana zibe ngu-100%. Umphumela ophakeme wokuhlolwa kokuqukethwe awuzisusanga ezinye izinto eziqinile noma wandise inani likadayi. Uguqule ukuqhathanisa, kwasuka esampuleni lonke njengoba lamukelwe kwaya engxenyeni yalo eyomile.
Ngakolunye uhlangothi, umbiko obonisa ukuhlolwa kokuqukethwe ngokwesisekelo esomile okungu-99.0% nokulahleka kwesisindo lapho komiswa okungu-12.0% usho ukuthi ukuhlolwa kokuqukethwe njengoba kwamukelwe kungu-99.0 × 0.88 = 87.12%, uma izimo ezicatshangwa yindlela yokuhlola zigcwaliseka. Ukuqhathanisa lowo-87.12% ngokuqondile nomphumela womunye umhlinzeki ongu-99.0% ngokwesisekelo esomile kungaba ukuqhathanisa amanani ahlukene.
Amanzi angabuye abe yingxenye yesimo sekristalu esibophe amanzi. Umehluko phakathi kwe-methylene blue trihydrate nento engenamanzi uchaza ukuthi kungani isisindo sefomula nesisekelo sokuhlolwa kokuqukethwe kufanele kuhambisane. Ilebula lesimo sokubopha amanzi alithathi indawo yomphumela wamanzi noma wokomisa oqondene neqoqo elithile.
Kungani umphumela obikiwe wokuhlolwa kokuqukethwe ungadlula ku-100%
Ukubala isisindo esomile ngendlela efanele kusetshenziswa izilinganiso ezinembile ngokuphelele akukwazi ukwenza ingxenye yangempela yesisindo ibe ngaphezu kuka-100%. Umphumela ongaphezu kwalowo mkhawulo uvela endleleni isilinganiso sokuhlaziya esitholakala ngayo, kuhlanganise nokungaqiniseki kokulinganisa, ukuchema okungenzeka, noma inkinga yokubika noma yokubala.
Umbiko osemthethweni wokubuyekezwa kwe-USP kaSepthemba 2023 uchaza ukuhlolwa kokuqukethwe okuqhathanisa impendulo yesampula ku-chromatography yoketshezi nezinga eliyisethenjwa. Kuwukunquma inani ngokulinganisa ngereferensi, hhayi ukuhlukanisa nokukala isisindo sazo zonke izinto ezisempushaneni. Inani elabelwe izinga eliyisethenjwa, ukukala isisindo, ukuhlambulula, impendulo yethuluzi, nokulungisa ngenxa yokomisa kungathinta isilinganiso esibikiwe.
Cabanga ngesampula lesibili elicatshangelwayo: u-90 g we-methylene blue no-10 g wamanzi. Ingxenye yalo yangempela ngokwesisekelo esomile ingu-100%. Uma impendulo yokuhlolwa kokuqukethwe iphakeme ngo-1% futhi ukulungisa ngenxa yokomisa kunembe ngokuphelele kwezinye izici, indlela yokuhlola ilinganisela okulingana no-90.9 g ku-100 g wokuqala. Ukulungisa leso silinganiso kunikeza u-90.9 / 90 × 100 = 101.0%. Lo-0.9 g owengeziwe uwukulinganisela okweqile, hhayi into eyengeziwe.
Incazelo ye-NIST yokungaqiniseki kokulinganisa ihlukanisa isilinganiso esitholwe ngokukala nolwazi olunembile ngokuphelele lwenani langempela elikalwayo. Ilabhorethri kufanele ihlole ukungaqiniseki kwayo. Imfuneko engu-97.0% kuya ku-103.0% ayifakazeli ukuthi indlela inokuthi “ukungaqiniseki kungu-±3%.” Futhi umphumela ophakeme awufakazeli ukuthi ubangelwe ukuhlukahluka okungahleliwe. Imiphumela ephakeme eqhubekayo idinga ukuba kuhlolwe ukulinganiswa kwamathuluzi, ukulungiswa kwesampula, izici zokulungisa, nesisekelo sokubala.
Isifinyezo sesiphakamiso se-USP sango-2026 sizichaza ngokusobala njengesiphakamiso esisekelwe enguqulweni esemthethweni kaSepthemba 2023. Ukubuyekezwa okuhlongozwayo akufanele kuthathwe njengemfuneko yokuhlola esisebenzayo ngenxa nje yokuthi kunosuku olusha.
Okuqukethwe udayi nobumsulwa obulinganiswa nge-chromatography kuphendula eminye imibuzo
“Okuqukethwe udayi” kudinga indlela nesisekelo esishiwo. Ngokwesibonelo, imininingwane yezimfuneko ze-M9140 yakwa-Sigma-Aldrich ibala okuqukethwe udayi okungenani okungu-82% kudayi wokufaka umbala ezicutshini noma emasampuleni ezinto eziphilayo osesimweni esibophe amanzi. Lelo nani eliphansi elivunyelwe alilona inani elilinganisiwe lawo wonke amaqoqo. Alisho ukuthi ingxenye esele iwukungcola okuyingozi, futhi alifakazeli ukulingana nezimfuneko zemithi.
Ngokufanayo, iphesenti lendawo ku-chromatography lehlukanisa indawo yesiqongo esisodwa esitholakele ngesamba esichaziwe sezindawo zeziqongo. Alihlukanisi ngokuzenzakalela isisindo se-methylene blue ngesisindo sesampula lonke. Umhlahlandlela we-USP wokuthunyelwa kwedatha ye-chromatography uhlukanisa ukwenza izindawo zibe amaphesenti esamba nokubala kusetshenziswa izinga eliyisethenjwa elingaphandle, futhi uchaza izici zokulungisa umehluko wezimpendulo, ngoba izisindo ezilinganayo zingakhiqiza izimp equndulo ezihlukene zomtshina.
| Okufakwe embikweni njengesibonelo | Lokho izibalo ezikufakazelayo | Lokho ezingakufakazeli |
|---|---|---|
| Indawo yesiqongo esiyinhloko 990,000; indawo ephelele efakiwe 1,000,000 | U-99.0% wempendulo efakiwe ebalwe ngokuhlanganisa izindawo | U-99.0% wesisindo sempuphu njengoba yamukelwe |
| Indawo yesiqongo sokungcola 10,000; indawo ephelele efakiwe 1,000,000 | Indawo engu-1.0% ngaphansi kwaleyo ndlela yokuhlanganisa izindawo | Isisindo esingu-1.0% ngaphandle kobudlelwano obudingekayo bempendulo |
| I-elementi elinganisiwe engu-5 mg/kg | Izingxenye ezi-5 esigidini ngokwesisindo, noma u-0.0005% | Inani elingasuswa ngokuqondile ephesentini lendawo elingahlobene nalo |
Umtshina ungase ungawalinganisi amanzi, usawoti ongaphili, noma zonke izinto ezingcolisayo eziphilayo ngokwekhemikhali ngaphansi kwezimo ezikhethiwe. Ngakho imiphumela yokuhlolwa kokuqukethwe okuhlukene ingaba khona ndawonye ngaphandle kokuhlangana kahle ibe ngu-100%. Umphumela wokungcola kwezinto eziphilayo ngokwekhemikhali, ukuhlaziywa kwama-elementi, nokulahleka kwesisindo lapho komiswa kuyizilinganiso eziphelelisanayo.
Funda umphumela njengengxenye yombiko
Sebenzisa umhlahlandlela wokufunda isitifiketi sokuhlaziya ukuze uthole ukuhlonza iqoqo, indlela yokuhlola, isisekelo sokubika, umphumela olinganisiwe, nomkhawulo wokwamukela. Gcina umphumela ngamunye namayunithi awo nedenominetha yawo. Ekubaleni izixazululo zaselabhorethri, isibali se-molarity ye-methylene blue sibeka ngokusobala okucatshangwayo ngesimo sento nangokuhlolwa kokuqukethwe.
Umphumela wokuhlolwa kokuqukethwe ongu-101% ungahlangabezana nezimfuneko zalokho kuhlolwa kuyilapho olunye uhlolo oludingekayo lwehluleka. Umphumela ongu-99% awukwazi ukufakazela ukungabi namagciwane, amazinga amukelekile okungcola kwama-elementi, noma ukugunyazwa komkhiqizo. Incazelo ye-methylene blue yezinga le-USP incike ezimfunekweni ezisebenzayo sezizonke. Ukuqhathanisa ikhwalithi okunenzuzo kubuza ukuthi into echazwe emibhalweni iyahlangabezana yini nalezo zimfuneko, kunokuklelisa abahlinzeki ngokwephesenti elikhulu kunawo wonke.