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

D-Sorbitol (CAS: 50-70-4) EP8.7 Usoro ule
D-glucitol (D-sorbitol).
Ọdịnaya: 97.0 pasent ruo 102.0 pasent (ihe na-ekpo ọkụ).
ÀMÀ
Ọdịdị: ọcha ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ọcha, ntụ ntụ crystalline.
Solubility: soluble nke ukwuu na mmiri, ihe fọrọ nke nta ka ọ bụrụ ihe a na-apụghị ịsacha na ethanol (pasent 96).
Ọ na-egosi polymorphism (5.9).
EZIOKWU
njirimara mbụ: A.
Ihe njirimara nke abụọ: B, C, D
A. Nyochaa chromatograms enwetara na nyocha.
Nsonaazụ: ọnụ ọgụgụ kachasị elu na chromatogram nke enwetara na ngwọta nnwale yiri oge njide na nha ya na ọnụ ọgụgụ kachasị elu na chromatogram enwetara na ngwọta ntụaka (a).
B. Gbari 0,5 g na kpo oku na ngwakọta nke 0,5 ml nke pyridine Rand 5 mL nke acetic anhydride R. Mgbe 10 min wụsa ngwọta n'ime 25 ml mmiri Rand kwe ka guzo na mmiri oyi maka 2 h.Ọkpụkpọ ahụ, recrystallised sitere na obere olu ethanol (pasent 96) R ma mịrị amị na vacuo, gbazee (2.2.14) na 98 ℃ ruo 104 ℃.
C. chromatography nke dị obere (2.2.27).
Ngwọta ule.Gbarie 25 mg nke ihe a ga-enyocha n'ime mmiri R wee jiri otu ihe mgbaze mee ka ọ bụrụ 10 ml.
Ngwọta ntụaka (a).Gbari 25 mg nke sorbitol CRS n'ime mmiri R wee gbanye 10 ml na otu ihe mgbaze.
Ngwọta ntụaka (b).Gbari 25 mg nke mannitol CRS na 25 mg nke sorbitol CRS n'ime mmiri R wee gbasaa na 10 ml na otu ihe mgbaze.
Efere: TLC silica gel G efere R.
Usoro mkpanaka: mmiri R, ethyl acetate R, propanol R (10: 20: 70V / V / V).
Ngwa: 2 μL
Mmepe: n'elu ụzọ nke 17cm
Ịkpọ nkụ: na ikuku.
Nchọpụta: fesa na 4-aminobenzoic acid ngwọta R;akọrọ na ikuku oyi dị ugbu a ruo mgbe ewepụrụ acetone;okpomọkụ na 100 ℃ maka 15min;ekwe ka ajụkwa ma fesaa na 2g/L ngwọta nke sodium periodate R;akọrọ na ikuku oyi dị ugbu a;okpomọkụ na 100 ℃ maka 15 min.
Ndabara sistemu: ngwọta ntụaka (b):
- chromatogram na-egosi ntụpọ 2 kewapụrụ nke ọma.
Nsonaazụ: isi ntụpọ na chromatogram enwetara na ngwọta ule yiri ya na ọnọdụ, agba na nha na isi ntụpọ na chromatogram nwetara site na ntụnye ntụaka (a).
D. Ntugharị ngwa anya akọwapụtara (2.2.7): +4.0 ruo +7.0 (ihe anhydrou).
Gbari 5.00 g nke ihe a ga-enyocha na 6.4 g nke disodium tetraborate R na 40 ml mmiri R. Kwe ka guzoro maka 1h, na-ama jijiji mgbe ụfọdụ, na-atụgharị na 50.0mL na mmiri R. Nyocha ma ọ bụrụ na ọ dị mkpa.
Nnwale
Ọdịdị nke ngwọta. Ihe ngwọta doro anya (2.2.1) na enweghị agba (2.2.2, Method II).
Gbari 5 g n'ime mmiri R wee gbanye 50 ml na otu ihe mgbaze.
Ịrụ ọrụ (2.2.38): kacha 20 μS · cm-1
Igbari 20.0 g incarbon dioxide mmiri na-adịghị akwadoro site na distilled mmiri R na itughari ka 100.0 ml na ihe mgbaze.Tulee conductivity nke ngwọta ka ị na-eji nwayọọ na-akpali akpali na magnetik.
Mbelata shuga: kacha 0.2 pasent, gosipụtara dị ka glucose dakọtara.
Gbarie 5.0 g na mmiri 6 ml R site n'enyemaka nke ọkụ dị nro.Jụụ wee gbakwunye 20 ml nke cupri-citric ngwọta R na cha cha ole na ole.Kpoo ọkụ ka esi amalite mgbe nkeji 4 gachara ma nọgide na-esi esi maka nkeji 3.Jụọ ngwa ngwa ma tinye 100 ml nke ihe ngwọta 2.4 pasent V/V nke glacial acetic acid R na 20.0 ml nke 0.025 M ayodiin.Site na ịma jijiji na-aga n'ihu, gbakwunye 25 ml nke ngwakọta nke mpịakọta 6 nke hydrochloric acid R na 94 mmiri R na, mgbe mkpọda ahụ gbazere, titrate ngafe nke iodine na 0.05 M sodium thiosulfate na-eji 1 ml nke starch solution R, gbakwunyere. ruo na njedebe nke titration, dị ka egosi.Ọ bụghị ihe na-erughị 12.8 ml nke 0.05 M sodium thiosulfate achọrọ.
Ihe ndị metụtara ya.chromatography nke mmiri mmiri (2.2.29).
Ngwọta ule.Gbari 5.0 g nke ihe a ga-enyocha na 20 ml mmiri R wee gbanye 100.0 ml na otu ihe mgbaze.
Ngwọta ntụaka (a).Gbari 0.50g nke sorbitol CRS na 2 ml mmiri R wee gbanye 10.0 ml na otu ihe mgbaze.
Ngwọta ntụaka (b).Ghichaa 2.0ml nke ngwọta ule na 100.0 ml na mmiri R.
Ngwọta ntụaka (c).Ghichaa 5.0 ml nke ngwọta ntụaka (b) na 100.0 ml na mmiri R.
Ngwọta ntụaka (d).Gbari 0.5g nke sorbitol R na 0,5 g nke mannitol R (adịghị ọcha A) na 5 ml mmiri R wee gbanye 10.0 ml na otu ihe mgbaze.
Ogidi:
– nha: l=0.3m,Ø=7.8mm
- nkeji oge: ike cation-exchange resin (ụdị calcium) R (9 μm);
– Okpomọkụ: 85±1°C
Usoro mkpanaka: mmiri na-ekpo ọkụ R.
Onu ogugu: 0.5ml/min
Nchọpụta: refractometer na-edobe na okpomọkụ mgbe niile (dịka 35 Celsius C).
Injection: 20μL nke ngwọta ule na ngwọta ntụaka (b) (c) na (d)
Oge ịgba ọsọ: ugboro abụọ na oge njigide nke sorbitol.
Njide njikọ na-ezo aka na sorbitol (oge njide = banyere 27 min): adịghị ọcha C = banyere 0.6;adịghị ọcha A = ihe dịka 0.8;adịghị ọcha B = ihe dịka 1.1.
Ndabara sistemu: ngwọta ntụaka (d):
-Mkpebi: opekempe 2.0 n'etiti ọnụ ọgụgụ kachasị elu n'ihi adịghị ọcha A na sorbitol.
Oke:
-adịghị ọcha ọ bụla: maka adịghị ọcha ọ bụla, ọ bụghị karịa mpaghara nke isi elu na chromatogram nwetara na ngwọta ntụaka (b) (2%);
-mkpokọta: ọ bụghị ihe karịrị 1.5 ugboro mpaghara nke isi elu na chromatogram nwetara site na ntinye aka (b) (3%);
–nleghara oke: mpaghara nke isi elu na chromatogram nwetara na ntụaka ngwọta (c) (0.1 percent).
Ndu (2.4.10): kacha 0.5 ppm.
Nickel (2.4.15): kacha 1 ppm.
Gbanyụọ ihe a ga-enyocha n'ime 150.0 ml nke ngwakọta edozi edozi.
Mmiri (2.5.12): kacha 1.5 pasent, kpebisiri ike na 1.00 g.Jiri ngwakọta nke 1 mpịakọta nke foramide R na mpịakọta 2 nke methanol anhydrous R dị ka ihe mgbaze.
Mmetọ microbial
Ọ bụrụ na e bu n'obi iji mee ihe n'imepụta nkwadebe parenteral:
– TAMC: akara nnabata 102CFU/g (2.6.12).
Ọ bụrụ na ebughị n'obi ka e jiri ya mee ihe n'imepụta nkwadebe parenteral:
– TAMC: akara nnabata 103CFU/g (2.6.12);
– TYMC: akara nnabata 102CFU/g (2.6.12);
- enweghị Escherichia coli (2.6.13);
- enweghị Salmonella (2.6.13).
Ọrịa endotoxins (2.6.14).Ọ bụrụ na e bu n'obi iji ya mee ihe maka imepụta nkwadebe parenteral na-enweghị usoro ọzọ kwesịrị ekwesị maka iwepụ endotoxins nje:
- ihe na-erughị 4 IU / g maka nkwadebe parenteral nwere ịta nke ihe na-erughị 100g / L nke sorbitol.
- ihe na-erughị 2.5 IU / g maka nkwadebe parenteral nwere ịta nke 100g / L ma ọ bụ karịa nke sorbitol.
ASSAY
Liquid chromatography (2.2.29) dị ka akọwara na ule maka ihe ndị metụtara ya na mgbanwe ndị a.
Injection: Ngwọta nnwale na ntụnye aka (a).
Gbakọọ ọdịnaya pasentị nke D-sorbitol site na ọdịnaya ekwuputara nke sorbitol CRS.
Ịkpọ aha
Akara ahụ kwuru:
- ebe ọdabara, ntinye kachasị nke nje endotoxins;
- ebe ọdabara, na ihe ahụ dabara adaba maka imepụta nkwadebe parenteral.
IHE adịghị ọcha
A.D-mannitol,
B.D-iditol,
C.4-O-a-D-glucopyranosyl-D-glucitol (D-maltitol).

D-Sorbitol (CAS: 50-70-4) Ule ule USP
Nkọwa
Sorbitol nwere NLT 91.0% na NMT 100.5% nke D-sorbitol, gbakọọ na anhydrous ndabere.Ọnụ ọgụgụ nke mkpokọta shuga, mmanya polyhydric ndị ọzọ, na hexitol anhydrides ọ bụla, ọ bụrụ na achọpụtara ya, esoghị n'ihe achọrọ, ma ọ bụ na ego agbakọtara n'okpuru adịghị ọcha ndị ọzọ na ọkwa izugbe.
Nchọpụta
• A.
Ihe ngwọta: 1 g nke sorbitol na 75 ml mmiri
Nyocha: Nyefee 3 ml nke ngwọta nlele na tube ule 15-cm, tinye 3 mL nke ngwọta catechol a kwadebere ọhụrụ (1 na 10), na mix.Tinye 6 ml nke sulfuric acid, wee jiri nwayọọ kpoo tube n'ime ọkụ maka 30 s.
• B. Oge njide nke isi ọnụ ọgụgụ kachasị elu nke ngwọta Sample kwekọrọ na nke ahụ sitere na ngwọta Standard, dị ka enwetara na Assay.
ASSAY
• Usoro
Usoro mkpanaaka: Jiri mmiri oyiri eme ihe.
Ngwọta dabara adaba na sistemụ: Kwadebe ngwọta nwere 4.8 mg / g nke USP Sorbitol RS na mannitol ọ bụla.
Ngwọta ọkọlọtọ: 4.8 mg / g nke USP Sorbitol RS
Ngwọta nlele: igbari 0.10 g nke Sorbitol n'ime mmiri ma gbanye mmiri na 20g.Dekọọ ibu ngwọta ikpeazụ, ma gwakọta nke ọma.
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Ụdị: LC
Nchọpụta: Ntụgharị uche
Ogidi: 7.8-mm x 10-cm;mbukota L34
Okpomọkụ
Ogidi: 50±2°
Ihe nchọpụta: 35°
Ọnụego mmiri: 0.7 ml/min
Nha igba ogwu: 10 μL
Sistemu kwesịrị ekwesị
Nlereanya: Ngwọta dabara adaba na sistemụ yana ngwọta ọkọlọtọ [MARA-Oge njigide maka mannitol na sorbitol bụ ihe dịka 0.6 na 1.0, n'otu n'otu.]
Kwesịrị ekwesị chọrọ
Mkpebi: NLT 2.0 n'etiti sorbitol na mannitol, usoro dabara adaba ngwọta
Ọkọlọtọ emetụtara: NMT 2.0%, Ọkọlọtọ ngwọta
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent, n'ụdị anhydrous, nke D-sorbitol na akụkụ nke Sorbitol were:
Nsonaazụ = (rU/rS) x (CS/CU) x (100/(100 -W)) x 100
rU= nzaghachi kacha elu sitere na ngwọta Sample
rS= nzaghachi kacha elu sitere na ngwọta Standard
CS = itinye uche nke USP Sorbitol RS na ngwọta ọkọlọtọ (mg/g)
CU = itinye uche nke Sorbitol na ngwọta nlele (mg/g)
W= pasent nke enwetara na ule maka Mkpebi Mmiri
Ụkpụrụ nnabata: 91.0%-100.5% na ndabere anhydrous
IHE adịghị ọcha
• LIMITOF NICK
Ngwọta nlele: Igbari 20.0 g nke Sorbitol na acetic acid diluted, wee jiri acetic acid diluted mee ka ọ bụrụ 150 ml.
Ihe ngwọta efu: 150 ml nke acetic acid diluted
Ngwọta ọkọlọtọ: Kwadebe ngwọta atọ site n'ịgbakwunye 0.5, 1.0, na 1.5 ml nke nickel standard solution TS na 20.0 g nke Sorbitol gbazere na acetic acid diluted, ma gbanye otu ihe mgbaze na 150 ml.
Ọnọdụ akụrụngwa
(Lee Spectrophotometry na Mgbasa ọkụ <851>)
Ụdị: spectrophotometry absorption atom
Ogologo ebili mmiri nyocha: 232.0 nm
oriọna: Nickel hollow-cathode
Ọkụ: Air-acetylene
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Na nke ọ bụla sample tinye 2.0 ml nke a jujuru ammonium pyrrolidinedthiocarbamate ngwọta (nwere 10g/L nke ammonium pyrrolidinedthiocarbamate) na 10.0 ml nke methyl isobutyl ketone, na ịma jijiji maka 30 s.Chebe pụọ na ìhè na-egbuke egbuke.Kwe ka akwa abụọ ahụ kewaa, ma jiri methyl isobutyl ketone oyi akwa.Tọọ ngwa ahụ ka ọ bụrụ efu site na iji oyi akwa si na ngwọta oghere.
N'otu oge chọpụta absorbances nke organic oyi akwa si Sample opekata mpe ugboro atọ ọ bụla.Dekọọ nkezi nke ọgụgụ na-aga n'ihu maka nke ọ bụla n'ime ọkọlọtọ ọkọlọtọ na ngwọta Sample.N'etiti nha nke ọ bụla, chọọ oyi akwa organic site na ngwọta oghere, wee chọpụta na ọgụgụ ahụ na-alaghachi na efu.Chee echiche nnabata nke ngwọta Standard yana ihe ngwọta Sample na ọnụọgụ nickel agbakwunyere.
Extrapolate ahịrị ijikọ isi ihe dị na eserese ahụ ruo mgbe ọ zutere axis itinye uche.Ebe dị n'etiti ebe a na nkwụsị nke axes na-anọchite anya ntinye nke nickel na ngwọta Sample.
Usoro nnabata: NMT 1 ppm
• MKWAGHỊ MGBE KWESỊRỊ <281>: NMT 0.1%, kpebisiri ike na akụkụ 1.5g
Mbelata shuga
[IHE-Ogo ekpebisiri ike na ule a esonyeghị na ego a gbakọrọ n'okpuru adịghị ọcha ndị ọzọ na ọkwa izugbe.]
Ngwọta nlele: gbazee 3.3 g nke Sorbitol na 3 ml mmiri site n'enyemaka nke ọkụ dị nro.Jụụ, ma tinye 20.0 ml nke cupric citrate TS na obere iko iko.Kpoo ọkụ ka esi amalite mgbe nkeji 4 gachara, ma nọgide na-esi esi maka nkeji 3.Jụọ ngwa ngwa, tinye 40 ml nke acetic acid diluted, 60 ml mmiri, na 20.0 ml nke 0.05 N iodine VS.Site na ịma jijiji na-aga n'ihu, tinye 25 ml nke ngwakọta nke 6 ml hydrochloric acid na 94 ml mmiri.
Nyocha: Mgbe mmiri ozuzo gbazere, titrate ngafe nke ayodiin na 0.05 N sodium thiosulfate VS na-eji 2mL nke starch TS, gbakwunyere na njedebe nke titration, dị ka ihe ngosi.
Usoro nnabata: NLT 12.8 ml nke 0.05 N sodium thiosulfate VS chọrọ, dabara na NMT 0.3% nke ibelata shuga, dị ka glucose.
• CHLORIDEAND SULFATE, Chloride <221> (ọ bụrụ na akpọrọ ya maka iji na-akwadebe ụdị usoro onunu ogwu)
Ihe atụ: 1.5 g
Usoro nnabata: Ihe nlele ahụ egosighi chloride karịa ka dabara na 0.10 ml nke 0.020 N hydrochloric acid (NMT 0.0050%).
• CHLORIDEAND SULFATE, Sulfate <221> (ọ bụrụ na akpọrọ ya maka iji na-akwadebe ụdị doses nke parenteral)
Ihe atụ: 1.0 g
Usoro nnabata: Ihe nlele ahụ egosighi sulfate karịa dabara na 0.10 ml nke 0.020 N sulfuric acid (NMT 0.01%).
Nnwale akọwapụtara
• MICROBIAL ENUMERATION TESTS <61> na Ule maka MICROORGANISMS akọwapụtara <62>: Ngụkọta ikuku ikuku na-eji usoro Plate bụ NMT 1000 cfu/g, yana ngụkọta nke ebu na yeasts jikọtara ọnụ bụ NMT 100 cfu/g.
• PH <791>: 3.5-7.0, na ngwọta 10% (w / w) na mmiri na-enweghị carbon dioxide.
• Mkpebi mmiri, Usoro I <921>: NMT 1.5%
CLARITYAND COLOROF SOLUTION(ọ bụrụ na akpọnyere ya maka iji na-akwadebe ụdị usoro onunu ogwu)
Ihe atụ: 10.0 g
Nyocha: Gbarie ihe nlele ahụ na 100.0 ml nke mmiri na-enweghị carbon dioxide.
Usoro nnabata: Ihe ngwọta doro anya na enweghị agba.
• BACTERIAL ENDOTOXINS TEST <85> (ma ọ bụrụ na akpọrọ ya maka iji na-akwadebe ụdị doses nke parenteral): NMT 4 USP Endotoxin Units / g maka ụdị usoro ọgwụgwọ parenteral nwere mkpokọta ihe na-erughị 100g / L nke sorbitol, yana NMT 2.5 USP Endotoxin Units/g Maka usoro onunu ogwu nke parenteral nwere ntinye nke 100 g / l ma ọ bụ karịa nke sorbitol.
NKWUO GBASARA YA
• Nkwakọba nkwakọba: Chekwaa n'ime akpa mechiri emechi nke ọma.Ọnweghị ihe nchekwa achọrọ akọwapụtara.
• akara: Sorbitol ezubere maka iji na-akwadebe ụdị usoro onunu ogwu ka akpọrọ ya.
Ụkpụrụ ntụaka USP <11>
USP Endotoxin RS
USP Sorbitol RS