D-Sorbitol CAS 50-70-4 Assay 97.0~100.5% Factory High Quality

D-Sorbitol (CAS: 50-70-4) EP8.7 Tikanga Whakamatau
D-Glucitol (D-sorbitol).
Ihirangi: 97.0 ōrau ki te 102.0 ōrau (matū waikore).
KAUPAPA
Te ahua: he ma, he tata ma ranei, he paura tioata.
Wairewa: tino memeha ki te wai, karekau e rewa ki te waihano (96 paiheneti).
E whakaatu ana i te polymorphism (5.9).
WHAKATAUTANGA
Te tohu tuatahi: A.
Tautuhi tuarua: B, C, D
A. Tirohia nga chromatograms i whiwhi i te whakamatautau.
Hua: Ko te tihi matua o te chromatogram i whiwhi me te otinga whakamatautau he rite te wa pupuri me te rahi ki te tihi matua o te chromatogram i whiwhi ki te otinga tohutoro (a).
B. Whakarewahia te 0.5 g me te whakamahana ki te ranunga o te 0.5 mL o te pyridine Rand 5 mL o te acetic anhydride R. I muri i te 10 meneti ka ringihia te wairewa ki te 25 mL o te wai Rand tukua kia tu ki te wai tio mo te 2 haora.Ko te rerenga, ka rerystallised mai i te iti o te waiwaro (96 paiheneti) R ka whakamaroke ki te korehau, ka rewa (2.2.14) i te 98 ℃ ki te 104 ℃.
C. Paparanga angiangi chromatography (2.2.27).
Te otinga whakamatautau.Whakarewahia te 25 mg o te matū ka tirohia ki roto i te wai R ka waimeha ki te 10 mL me te whakarewa ano.
Te otinga tohutoro (a).Whakarewahia te 25 mg o te sorbitol CRS ki te wai R ka waimeha ki te 10 mL me te whakarewa ano.
Te otinga tohutoro (b).Whakarewahia te 25 mg o te mannitol CRS me te 25 mg o te sorbitol CRS ki te wai R ka waimeha ki te 10 mL me te whakarewa ano.
Pereti: TLC silica gel G plate R.
Wāhanga pūkoro: wai R, ethyl acetate R, propanol R (10:20:70V/V/V).
Taupānga: 2 μL
Whanaketanga: i runga i te ara 17cm
Te whakamaroke: i te hau.
Te kimi: rehu ki te wairewa waikawa 4-aminobenzoic R;maroke i roto i te hau makariri kia tangohia ra ano te acetone;wera i te 100 ℃ mo te 15min;tukua ki te whakamatao me te rehu ki te wairewa 2g/L o te konutai periodate R;maroke i te ia o te hau makariri;wera i te 100 ℃ mo te 15 min.
Te pai o te punaha: otinga tohutoro (b):
– e whakaatu ana te chromatogram e 2 nga waahi kua wehea marama.
Hua: Ko te waahi matua o te chromatogram i whiwhi me te otinga whakamatautau he rite te tuunga, te tae me te rahi ki te waahi matua o te chromatogram i whiwhi ki te otinga tohutoro (a).
D. Te hurihanga whatu motuhake (2.2.7): +4.0 ki te +7.0 (matū anhydrou).
Whakarewahia te 5.00 g o te matū hei tirotirohia me te 6.4 g o te disodium tetraborate R i roto i te 40 mL wai R. Tukua kia tu mo te 1h, ka wiri i etahi wa, ka waimeha ki te 50.0mL ki te wai R. Whiriwhiria mehemea e tika ana.
WHAKAMAHI
Te ahua o te otinga.He maamaa te otinga(2.2.1) me te kore tae (2.2.2, Tikanga II).
Whakarewahia te 5 g ki te wai R ka waimeha ki te 50 mL me te whakarewa ano.
Te kawe (2.2.38): 20 μS·cm−1 mōrahi
Whakarewahia te 20.0 g te wai kore-waro-kore R i mahia mai i te wai maturu R ka waimeha ki te 100.0 mL me te whakarewa ano.Ine i te kawe o te wairewa i te ata whakakorikori ki te whakakorikori autō.
Huka whakaheke: te 0.2 paiheneti teitei, e kiia ana he rite te hukahuka.
Whakarewahia te 5.0 g ki te 6 mL wai R me te awhina o te wera ngawari.Mataohia ka tapirihia te 20 mL o te wairewa kapu-citric R me etahi pirepire karaihe.Whakawerahia kia timata te koropupu i muri i te 4 meneti ka pupuri kia koropupu mo te 3 meneti.Kia whakamatao, ka tapirihia he 100 mL o te wairewa 2.4 paiheneti V/V o te waikawa ahetiki huka R me te 20.0 mL o te 0.025 M iodine.Ma te wiri tonu, tāpirihia te 25 mL o te ranunga o te 6 rōrahi o te waikawa pūhaumāota R me te 94 rōrahi wai R, ā, ka rewa te wairere, whakatāhia te taikaha o te iodine ki te 0.05 M konutai thiosulfate mā te 1 mL o te wairewa māngaro R, tāpirihia. ki te mutunga o te titration, hei tohu.Kaua e iti iho i te 12.8 mL o te 0.05 M konutai thiosulfate e hiahiatia ana.
Matū whai pānga.Koromatography wai(2.2.29).
Te otinga whakamatautau.Whakarewahia te 5.0 g o te matū ka tirohia ki te 20 mL wai R ka waimeha ki te 100.0 mL me te whakarewa ano.
Te otinga tohutoro (a).Whakarewahia te 0.50g o te sorbitol CRS ki te 2 mL wai R ka waimeha ki te 10.0 mL me te whakarewa ano.
Te otinga tohutoro (b).Ringihia te 2.0mL o te otinga whakamatautau ki te 100.0 mL ki te wai R.
Te otinga tohutoro (c).Ringihia te 5.0 mL o te otinga tohutoro (b) ki te 100.0 mL ki te wai R.
Te otinga tohutoro (d).Whakarewahia te 0.5g o te sorbitol R me te 0.5 g o te mannitol R (te poke A) ki te 5 mL o te wai R ka waimeha ki te 10.0 mL me te whakarewa ano.
Tīwae:
–rahi:l=0.3m,Ø=7.8mm
–waahanga noho: te kapia whakawhiti katote kaha (te ahua konupora) R (9 μm);
–mahana: 85±1°C
Wāhanga pūkoro: wai whakaheke R.
Rere rere: 0.5mL/min
Rapunga: ka mau tonu te inenga whakaata i te pāmahana tonu (hei tauira, 35 °C).
Werohanga: 20μL o te otinga whakamatautau me nga otinga tohutoro (b) (c) me (d)
Te wa oma: rua te wa pupuri o te sorbitol.
Te pupuri whanaunga me te tohutoro ki te sorbitol (wa pupuri = tata ki te 27 min): poke C = tata ki te 0.6;poke A = āhua 0.8;poke B = āhua 1.1.
Te pai o te punaha: otinga tohutoro (d):
–taumira: 2.0 iti rawa i waenga i nga tihi na te poke A me te sorbitol.
Tepe:
–tetahi poke: mo ia poke, kaua e neke ake i te horahanga o te tihi matua o te chromatogram i whiwhi ki te otinga tohutoro (b) (2 paiheneti);
–tapeke: kaua e neke ake i te 1.5 whakareatanga te horahanga o te tihi matua o te chromatogram i whiwhi ki te otinga tohutoro (b) (3 paiheneti);
–kaore e aro: te horahanga o te tihi matua o te chromatogram i whiwhi ki te otinga tohutoro (c) (0.1 ōrau).
Arataki (2.4.10): teitei 0.5 ppm.
Nickel (2.4.15): teitei 1 ppm.
Whakarewahia te matū hei tirotiro i te 150.0 mL o te ranunga whakarewa kua tohua.
Te wai (2.5.12): 1.5 paiheneti teitei, kua whakatauhia ki te 1.00 g.Whakamahia te ranunga o te 1 pukapuka o te formamide R me te 2 pukapuka o te mewaro R anhydrous hei whakarewa.
Te poke moroiti
Mena i whakaarohia mo te whakamahi i roto i te hanga o nga whakaritenga parenteral:
– TAMC: paearu whakaae 102CFU/g (2.6.12).
Mena kaore i whakaarohia mo te whakamahi i roto i te hanga o nga whakaritenga parenteral:
– TAMC: paearu whakaae 103CFU/g (2.6.12);
– TYMC: paearu whakaae 102CFU/g (2.6.12);
– te kore o Escherichia coli (2.6.13);
–kore o Salmonella (2.6.13).
Endotoxins huakita(2.6.14).Mena i whakaarohia mo te whakamahi i roto i te hanga o nga whakaritenga matua kaore he tikanga tika mo te tango i nga endotoxins huakita:
– iti iho i te 4 IU/g mo nga whakaritenga matua he iti iho i te 100g/L te kukū o te sorbitol
– iti iho i te 2.5 IU/g mo nga whakaritenga matua he 100g/L neke atu ranei te kukū o te sorbitol
WHAKAMAHI
Ko te chromatography wai (2.2.29) i whakaahuatia i roto i te whakamatautau mo nga matū e whai ake nei.
Werohanga: otinga whakamatautau me te otinga tohutoro (a).
Tātaihia te ōrau o te D-sorbitol mai i te ihirangi o te sorbitol CRS.
TARANGA
E kii ana te tapanga:
– i te wa e tika ana, te kukū nui o nga endotoxins huakita;
– mena e tika ana, e tika ana te matū mo te hanga i nga whakaritenga a te matua.
NGA POKE
A. D-manitol,
B. D-iditol,
C. 4-O-α-D-glucopyranosyl-D-glucitol (D-maltitol).

D-Sorbitol (CAS: 50-70-4) Tikanga Whakamātautau USP
WHAKAMAHI
Kei roto i te Sorbitol te NLT 91.0% me te NMT 100.5% o te D-sorbitol, kua tatauhia i runga i te kaupapa anhydrous.Ko nga nui o te huka katoa, etahi atu waipiro polyhydric, me etahi hexitol anhydride, mena ka kitea, kaore i uru ki roto i nga whakaritenga, kaore ano hoki i roto i te nui o te tatau i raro i etahi atu Parakore i roto i nga Panui Whakanui.
WHAKATAUTANGA
• A.
Tauira otinga: 1 karamu o Sorbitol i te 75 mL wai
Tātaritanga: Whakawhitihia te 3 mL o te Tauira otinga ki te ipuipu 15-cm, ka tapirihia te 3 mL o te wairewa catechol hou kua rite (1 i roto i te 10), ka uru.Tāpirihia te 6 mL o te waikawa pungatara, ka whakamahana ata te ngongo ki te mura mo te 30 hēkona.
• B. Ko te wa pupuri o te tihi nui o te otinga Tauira e rite ana ki tera mai i te otinga Paerewa, i riro mai i te Assay.
WHAKAMAHI
• TE WHAKAMAHI
Wāhanga pūkoro: Whakamahia te wai whakaheke.
Te otinga pai o te punaha: Whakaritea he otinga kei roto te 4.8 mg/g o ia USP Sorbitol RS me te mannitol
Te otinga paerewa: 4.8 mg/g o USP Sorbitol RS
Tauira otinga: Whakarewahia te 0.10 g o te Sorbitol ki te wai, ka waimeha ki te wai ki te 20g.Tuhia te taumaha otinga whakamutunga, ka uru pai.
Pūnaha Chromatographic
(Tirohia te Chromatography <621>, Whakaritenga Pūnaha.)
Aratau: LC
Kaitirotiro: Taupū Refactive
Tīwae: 7.8-mm x 10-cm;kiki L34
Te pāmahana
Tīwae: 50±2°
Kaitirotiro: 35°
Rere rere: 0.7 mL/min
Rahi werohanga: 10 μL
Te pai o te punaha
Tauira: Te otinga pai o te punaha me te otinga Paerewa [FAKATOKANGA-Ko nga wa pupuri mo te mannitol me te sorbitol he tata ki te 0.6 me te 1.0, ia.]
Nga whakaritenga e tika ana
Whakatau: NLT 2.0 i waenga i te sorbitol me te mannitol, Te otinga pai o te punaha
Te inenga paerewa whaitake: NMT 2.0%, otinga Paerewa
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Tātaihia te paheketanga, i runga i te tikanga kore, o D-sorbitol i te waahanga o te Sorbitol i tangohia:
Hua = (rU/rS) x (CS/CU) x (100/(100 -W)) x 100
rU= whakautu teitei mai i te Tauira otinga
rS= whakautu teitei mai i te otinga Paerewa
CS= te kukū o te USP Sorbitol RS i te otinga Paerewa (mg/g)
CU= te kukū o te Sorbitol i te Tauira otinga (mg/g)
W= ōrau i whiwhi i te whakamātautau mō te Whakatau Wai
Paearu whakaae: 91.0%–100.5% i runga i te waikore
NGA POKE
• LIMITOF NICKE
Tauira otinga: Whakarewahia te 20.0 g o Sorbitol ki te waikawa ahetiki waimeha, ka waimeha ki te waikawa ahetiki kua waimeha ki te 150 mL.
Wairewa patea: 150 mL o te waikawa ahetiki waimeha
Rongonga Paerewa: Whakaritea kia toru nga otinga ma te taapiri i te 0.5, 1.0, me te 1.5 mL o te wairewa paerewa nickel TS ki te 20.0 g o te Sorbitol kua memeha ki roto i te waikawa ahetiki kua waimeha, ka waimeha ki te whakarewa ano ki te 150 mL.
Nga tikanga taputapu
(Tirohia te Spectrophotometry me te Marara-marama <851>)
Aratau: Spectrophotometry ngota ngota
Te roangaru tātari: 232.0 nm
Rama: Nickel hollow-cathode
mura: Air–acetylene
Tātaritanga
Tauira: Nga otinga paerewa me te otinga Tauira
Ki ia tauira taapirihia te 2.0 mL o te wairewa pyrrolidinedithiocarbamate haukinia kukū (kei roto te 10g/L o te haukinia pyrrolidinedithiocarbamate) me te 10.0 mL o te methyl isobutyl ketone, ka wiri mo te 30 hēkona.Tiaki i te marama marama.Tukua kia wehe nga papa e rua, ka whakamahi i te apa methyl isobutyl ketone.Tautuhia te taputapu ki te kore ma te whakamahi i te paparanga waro mai i te otinga Patea.
Whakatauhia nga ngongo o te paparanga waro mai i nga Tauira kia toru nga wa ia ia.Tuhia te toharite o nga panui tuturu mo ia otinga Paerewa me te otinga Tauira.I waenganui i ia inenga, whakahiahia te paparanga waro mai i te wairewa Patea, me te mohio kei te hoki te panui ki te kore.Whakatakotoria te ngongo o nga otinga Paerewa me te otinga Tauira ki te nui o te nikel.
Whakanuia te raina e hono ana i nga tohu o te kauwhata kia tutuki ra ano ki te tuaka kukū.Ko te tawhiti i waenga i tenei waahi me te whakawhitinga o nga toki e tohu ana i te kukū o te nikel i roto i te otinga Tauira.
Paearu whakaae: NMT 1 ppm
• MAHI RANGI <281>: NMT 0.1%, kua whakatauhia i runga i te waahanga 1.5g
TE WHAKAITI I TE HUKA
[FAKATOKANGA-Ko te moni i whakatauhia i roto i tenei whakamatautau kaore i uru ki te moni tatau i raro i etahi atu poke i roto i nga Panui Nui.]
Tauira otinga: Whakarewahia te 3.3 g Sorbitol ki te 3 mL wai me te awhina o te wera ngawari.Matao, ka tapirihia he 20.0 mL o te cupric citrate TS me etahi pirepire karaihe.Whakawerahia kia timata te koropuputanga i muri i te 4 meneti, ka pupuri kia koropupu mo te 3 meneti.Kia whakamatao, ka tapirihia te 40 mL o te waikawa ahetiki kua waimeha, 60 mL wai, me te 20.0 mL o te 0.05 N iodine VS.Me te wiri tonu, tāpirihia te 25 mL o te ranunga o te 6 mL o te waikawa pūmāota me te 94 mL o te wai.
Tātaritanga: Kia rewa te para, whakatairitehia te taikaha o te iodine ki te 0.05 N konutai tiosulfate VS ma te whakamahi i te 2mL o te māngaro TS, ka tapirihia ki te mutunga o te titration, hei tohu.
Paearu whakaae: NLT 12.8 mL o 0.05 N konutai thiosulfate VS e hiahiatia ana, e rite ana ki te NMT 0.3% o te huka whakaheke, hei huka
• CHLORIDEAND SULFATE, Chloride<221> (mehemea ka tapaina mo te whakamahi ki te whakarite i nga puka inenga matua)
Tauira: 1.5 g
Paearu whakaae: Ko te Tauira e whakaatu ana kaore i nui ake te chloride ki te 0.10 mL o te 0.020 N waikawa pūhaumāota (NMT 0.0050%).
• CHLORIDEAND SULFATE, Sulfate <221> (mehemea ka tapaina mo te whakamahi ki te whakarite i nga puka inenga matua)
Tauira: 1.0 g
Paearu whakaae: Ko te Tauira e whakaatu ana kaore i nui ake te pūkawa i te rite ki te 0.10 mL o te 0.020 N waikawa pungatara (NMT 0.01%).
NGA WHAKAMATAUTANGA
• WHAKAMAHI WHAKATAUTANGA MICROBIAL <61> me nga WHAKATAUTANGA MO NGA MICROORGANISME WHAKATAHI <62>: Ko te tapeke aerobic e whakamahi ana i te Tikanga Plate he NMT 1000 cfu/g, a ko te tapeke o nga kohanga me te rewena he NMT 100 cfu/g.
• PH <791>: 3.5-7.0, i roto i te wairewa 10% (w/w) i roto i te wai waro haukore-kore
• WHAKATAUTANGA WAI, Tikanga I <921>: NMT 1.5%
CLARITY AND COLOROF SOLUTION(mehemea kua tapaina mo te whakamahi ki te whakarite i nga puka inenga matua)
Tauira: 10.0 g
Tātaritanga: Whakarewahia te Tauira ki roto i te 100.0 mL o te wai hauhā-kore.
Paearu whakaae: He maamaa te otinga me te kore tae.
• WHAKAMAHI ENDOTOXINS BACTERIAL <85> (mehemea kua tapaina mo te whakamahi i roto i te whakarite i nga puka inenga matua): NMT 4 USP Endotoxin Units/g mo nga puka inenga matua he iti iho i te 100g/L o te sorbitol, me te NMT 2.5 USP Endotoxin Units/g mo nga momo inenga matua he 100g/L neke atu ranei o te sorbitol.
HE WHAKAMAHI ATU
• PACKAGINGAND ROOM: Purihia ki roto i nga ipu kua kati pai.Kaore he whakaritenga rokiroki i tohua.
• WHAKATAPATANGA: Ko te Sorbitol i whakaritea mo te whakarite i nga puka inenga matua kua tapaina.
USP REFERENCE STANDARD <11>
USP Endotoxin RS
USP Sorbitol RS