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

D-Sorbitol (CAS: 50-70-4) EP8.7 Mokhoa oa Teko
D-Glucitol (D-sorbitol).
Likahare: liperesente tse 97.0 ho isa ho liperesente tse 102.0 (ntho e se nang metsi).
LIEKETSENG
Ponahalo: e tšoeu kapa e batla e le tšoeu, phofo ea crystalline.
Solubility: e qhibiliha haholo metsing, hoo e batlang e sa qhibilihe ka har'a ethanol (liperesente tse 96).
E bontša polymorphism (5.9).
LETSOOA
Boitsebiso ba pele: A.
Boitsebiso ba bobeli: B, C, D
A. Hlahloba li-chromatogram tse fumanoeng tekong.
Liphetho: tlhoro ea mantlha ea chromatogram e fumanoeng ka tharollo ea tlhahlobo e ts'oana ka nako ea ho boloka le boholo ho tlhoro ea mantlha ea chromatogram e fumanoeng ka tharollo ea litšupiso (a).
B. Qhala 0.5 g ka ho futhumatsa ka motsoako oa 0.5 mL ea pyridine Rand 5 mL ea acetic anhydride R. Kamora metsotso e 10 tšela tharollo ka 25 mL ea metsi Rand e lumella ho ema ka metsing a leqhoa bakeng sa 2 h.The precipitate, recrystallised ho tswa ho palo e nyane ea ethanol (96 per cent) R mme e omisitsoe ka vacuo, e qhibiliha (2.2.14) ho 98 ℃ ho isa ho 104 ℃.
C. Thin-layer chromatography (2.2.27).
Tharollo ea teko.Qhala 25 mg ea ntho e lokelang ho hlahlojoa ka metsing R 'me u hlapolle ho 10 ml ka solvent e tšoanang.
Tharollo ea litšupiso (a).Qhala 25 mg ea sorbitol CRS ka metsing R 'me u hlapolle ho 10 mL ka solvent e tšoanang.
Tharollo ea litšupiso (b).Qhala 25 mg ea mannitol CRS le 25 mg ea sorbitol CRS metsing R 'me u hlapolle ho 10 mL ka solvent e tšoanang.
Plate: TLC silica gel G poleiti R.
Mokhahlelo oa selefouno: metsi R, ethyl acetate R, propanol R (10:20:70V/V/V).
Kopo: 2 μL
Nts'etsopele: ho feta tsela ea 17cm
Ho omisa: moyeng.
Ho lemoha: fafatsa ka tharollo ea 4-aminobenzoic acid R;omella moeeng o batang ho fihlela acetone e tlosoa;mocheso ka 100 ℃ bakeng sa 15min;lumella ho pholile le ho fafatsa ka tharollo ea 2g / L ea sodium periodate R;omella moeeng o batang;mocheso ka 100 ℃ bakeng sa 15 min.
Ho tšoaneleha ha sistimi: tharollo ea litšupiso (b):
- chromatogram e bonts'a matheba a 2 a arohaneng ka ho hlaka.
Liphetho: sebaka sa mantlha sa chromatogram se fumanoeng ka tharollo ea tlhahlobo se tšoana ka boemo, 'mala le boholo le sebaka sa mantlha sa chromatogram se fumanoeng ka tharollo ea litšupiso (a).
D. Potoloho e khethehileng ea optical (2.2.7): +4.0 ho +7.0 (ntho ea anhydrou).
Qhala 5.00 g ya ntho e lokelang ho hlahlojwa le 6.4 g ya disodium tetraborate R ho 40 mL ya metsi R. Lumella ho ema bakeng sa 1h, ho sisinyeha ka linako tse ling, le ho hlapolla ho 50.0mL ka metsi R. Sefa ha ho hlokahala.
LITEKO
Ponahalo ea tharollo.Tharollo e hlakile(2.2.1) ebile ha e na mebala (2.2.2, Mokhoa oa II).
Qhibiliha 5 g ka metsing R 'me u hlapolle ho 50mL ka solvent e tšoanang.
Conductivity (2.2.38): boholo ba 20 μS·cm−1
Hlakola 20.0 g ea metsi a se nang carbon dioxide R a lokiselitsoeng ho tsoa metsing a hloekisitsoeng R 'me u hlapolle ho 100.0 mL ka solvent e tšoanang.Lekanya conductivity ea tharollo ha u ntse u susumetsa ka bonolo ka magnetic stirrer.
Ho fokotsa tsoekere: boholo ba liperesente tse 0.2, bo bonts'itsoeng joalo ka tsoekere e lekanang.
Hlakola 5.0 g ka 6 mL ea metsi R ka thuso ea mocheso o bonolo.Pholisa 'me u kenye 20 ml ea tharollo ea cupri-citric R le lifaha tse seng kae tsa khalase.Mocheso e le hore ho belisoa ho qala ka mor'a metsotso e 4 'me u lule u phehile bakeng sa 3 min.Fokotsa ka potlako mme o kenye 100 mL ya 2.4 per cent V/V motswako wa glacial acetic acid R le 20.0 mL ya 0.025 M iodine.Ka ho sisinyeha ho sa khaotseng, eketsa 25 ml ea motsoako oa li-volume tse 6 tsa hydrochloric acid R le 94 ea metsi a R, 'me, ha pula e qhibiliha, fokotsa ho feta ha iodine ka 0.05 M sodium thiosulfate u sebelisa 1 ml ea tharollo ea starch R, ho ea qetellong ea titration, joalo ka sesupo.E seng ka tlase ho 12.8 mL ea 0.05 M sodium thiosulfate ea hlokahala.
Lintho tse amanang.Mokelikeli oa chromatography (2.2.29).
Tharollo ea teko.Qhala 5.0 g ya ntho e lokelang ho hlahlojwa ka 20 ml ya metsi a R mme o hlapolle ho 100.0 mL ka solvent e tšoanang.
Tharollo ea litšupiso (a).Qhala 0.50g ea sorbitol CRS ka 2 mL ea metsi R 'me u hlapolle ho 10.0 mL ka solvent e tšoanang.
Tharollo ea litšupiso (b).Hlakola 2.0mL ea tharollo ea teko ho 100.0 mL ka metsi R.
Tharollo ea litšupiso (c).Hlakola 5.0 mL ea tharollo ea litšupiso (b) ho 100.0 mL ka metsi R.
Tharollo ea litšupiso (d).Hlakola 0.5g ea sorbitol R le 0.5 g ea mannitol R (litšila A) ka 5 ml ea metsi R 'me u hlapolle ho 10.0 mL ka solvent e tšoanang.
Kholomo:
–boholo:l=0.3m,Ø=7.8mm
-mohato o emeng: resin e matla ea cation-exchange (foromo ea calcium) R (9 μm);
-mocheso: 85±1°C
Mohato oa mobile: metsi a senyehileng R.
Sekhahla sa phallo: 0.5mL / min
Ho lemoha: refractometer e bolokiloe mochesong o sa khaotseng (mohlala, 35 °C).
Ente: 20μL ea tharollo ea teko le litharollo tsa litšupiso (b) (c) le (d)
Nako ea ho matha: habeli nako ea ho boloka sorbitol.
Ho boloka kamano e amanang le sorbitol (nako ea ho boloka = hoo e ka bang 27 min): ho se hloeke C = hoo e ka bang 0.6;ho se hloeke A = hoo e ka bang 0,8;litšila B = hoo e ka bang 1.1.
Ho tšoaneleha ha sistimi: tharollo ea litšupiso (d):
-qeto: bonyane 2.0 pakeng tsa litlhōrō ka lebaka la ho se hloeke A le sorbitol.
Meeli:
- litšila leha e le life: bakeng sa ho se hloeke ka 'ngoe, eseng ho feta sebaka sa tlhōrō e ka sehloohong ea chromatogram e fumanoang ka tharollo ea litšupiso (b) (2 lekholong);
-kakaretso: eseng makhetlo a fetang 1.5 sebaka sa tlhoro e ka sehloohong ea chromatogram e fumanoeng ka tharollo ea litšupiso (b) (3 lekholong);
-ho hlokomoloha moeli: sebaka sa tlhōrō e ka sehloohong ea chromatogram e fumanoeng ka tharollo ea litšupiso (c) (0.1 lekholong).
Ketapele (2.4.10): boholo ba 0.5 ppm.
Nickel (2.4.15): boholo ba 1 ppm.
Qhala ntho e lokelang ho hlahlojoa ka 150.0 mL ea motsoako o behiloeng oa metsoako.
Metsi (2.5.12): boholo ba karolo ea 1.5 lekholong, e ikemiselitseng ho 1.00 g.Sebelisa motsoako oa 1volume ea formamide R le li-volume tse 2 tsa anhydrous methanol R e le solvent.
Tšilafalo ea likokoana-hloko
Haeba e reretsoe ho sebelisoa ha ho etsoa litokisetso tsa parenteral:
– TAMC: tekanyetso ea ho amohela 102CFU/g (2.6.12).
Haeba e sa reretsoe ho sebelisoa ha ho etsoa litokisetso tsa parenteral:
- TAMC: tekanyo ea ho amohela 103CFU / g (2.6.12);
– TYMC: tekanyetso ea ho amohela 102CFU/g (2.6.12);
-ho se be teng ha Escherichia coli (2.6.13);
-ho ba sieo ha Salmonella (2.6.13).
Li-endotoxins tsa baktheria (2.6.14).Haeba e reretsoe ho sebelisoa ha ho etsoa litokisetso tsa batsoali ntle le mokhoa o mong o nepahetseng oa ho tlosa li-endotoxins tsa baktheria:
- ka tlase ho 4 IU / g bakeng sa litokisetso tsa batsoali ba nang le khatello ea maikutlo e ka tlase ho 100g/L ea sorbitol;
- ka tlase ho 2.5 IU/g bakeng sa litokisetso tsa batsoali tse nang le khatello ea maikutlo ea 100g/L kapa ho feta ea sorbitol;
TLHOKOMELO
Liquid chromatography (2.2.29) joalo ka ha ho hlalositsoe tekong ea lintho tse amanang le phetoho e latelang.
Ente: tharollo ea teko le tharollo ea litšupiso (a).
Bala palo ea liperesente tsa D-sorbitol ho tsoa ho litaba tse phatlalalitsoeng tsa sorbitol CRS.
LABELING
Label e re:
- moo ho hlokahalang, bongata bo boholo ba li-endotoxins tsa baktheria;
- moo ho hlokahalang, hore ntho e loketse ho sebelisoa ha ho etsoa litokisetso tsa batsoali.
LITŠILA
A. D-mannitol,
B. D-iditol,
C. 4-O-α-D-glucopyranosyl-D-glucitol (D-maltitol).

D-Sorbitol (CAS: 50-70-4) Mokhoa oa Tlhahlobo oa USP
TLHALOSO
Sorbitol e na le NLT 91.0% le NMT 100.5% ea D-sorbitol, e baloang ho latela anhydrous.Lipalo tsa kakaretso ea tsoekere, li-alcohol tse ling tsa polyhydric, le li-anhydrides tsa hexitol, ha li fumanwa, ha li kenyelelitsoe ho tse hlokoang, kapa palo e baliloeng tlas'a Litšila tse ling ho Litsebiso Kakaretso.
TS'ELISO TS'OANE
• A.
Tharollo ea mohlala: 1g ea Sorbitol ka 75 ml ea metsi
Tlhahlobo: Fetisetsa 3 mL ea tharollo ea Mohlala ho tube ea teko ea 15-cm, 'me u kenye 3 ml ea tharollo ea catechol e sa tsoa lokisoa (1 ho 10),' me u kopanye.Kenya 6 mL ea sulfuric acid, 'me ka bonolo u chese tube ka lelakabe la 30 s.
• B. Nako ea ho boloka tlhōrō e kholo ea tharollo ea Sample e lumellana le ea Tharollo ea Maemo, joalo ka ha e fumanoe ho Assay.
TLHOKOMELO
• TSAMAISO
Mohato oa Mobile: Sebelisa metsi a chesitsoeng.
Tharollo ea ho tšoaneleha ha Sisteme: Lokisetsa tharollo e nang le 4.8 mg/g ea USP e 'ngoe le e 'ngoe ea Sorbitol RS le mannitol
Tharollo e tloaelehileng: 4.8 mg / g ea USP Sorbitol RS
Tharollo ea mohlala: Hlakola 0.10 g ea Sorbitol ka metsing, 'me u hlapolle ka metsi ho 20g.Ngola boima ba tharollo ea ho qetela, 'me u kopanye hantle.
Sistimi ea chromatographic
(Sheba Chromatography <621>, Ho Hlokahala Sistimi.)
Mokhoa: LC
Detector: index ea refractive
Kholomo: 7.8-mm x 10-cm;ho paka L34
Mocheso
Kholomo: 50±2°
Mohloli: 35 °
Sekhahla sa phallo: 0.7 mL / min
Boholo ba ente: 10 μL
Ho nepahala ha sistimi
Mehlala: Tharollo ea ho tšoaneleha ha Sistimi le tharollo e Tloaelehileng [HLOKOMELA-Linako tse lekanyelitsoeng tsa ho boloka mannitol le sorbitol li ka ba 0.6 le 1.0, ka ho latellana.]
Litlhoko tsa ho tšoaneleha
Qeto: NLT 2.0 pakeng tsa sorbitol le mannitol, Tharollo ea ho tšoaneleha ha Sisteme
Phapang e amanang le maemo: NMT 2.0%, Tharollo e tloaelehileng
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Bala liphesente, motheong oa anhydrous, ea D-sorbitol karolong ea Sorbitol e nkiloeng:
Sephetho = (rU/rS) x (CS/CU) x (100/(100 -W)) x 100
rU= karabelo e phahameng ho tsoa ho Sample tharollo
rS= karabelo e phahameng ho tsoa ho Tharollo e Tloaelehileng
CS= mahloriso a USP Sorbitol RS ka har'a tharollo e tloaelehileng (mg/g)
CU= mahloriso a Sorbitol ka har'a tharollo ea Mohlala (mg/g)
W= peresente e fumanoeng tekong ea Boikemisetso ba Metsi
Mekhoa ea ho amohela: 91.0% -100.5% motheong oa anhydrous
LITŠILA
• LIMITED NICKE
Mohlala oa tharollo: Qhala 20.0 g ea Sorbitol ka acetic acid e hlapolotsoeng, 'me u hlapolle ka acetic acid e hlapolotsoeng ho 150 ml.
Tharollo e se nang letho: 150 ml ea acetic acid e hlapolotsoeng
Litharollo tse tloaelehileng: Lokisetsa litharollo tse tharo ka ho eketsa 0.5, 1.0, le 1.5 mL ea nickel standard solution TS ho 20.0 g ea Sorbitol e qhibilihisitsoeng ka acetic acid e hlapolotsoeng, 'me u hlapolle ka solvent e tšoanang ho 150 ml.
Maemo a liletsa
(Sheba Spectrophotometry le Light-Sscattering <851>)
Mokhoa: spectrophotometry ea ho monya atomic
Analytical wavelength: 232.0 nm
Lebone: Nickel hollow-cathode
Flame: Air-acetylene
Tlhahlobo
Mehlala: Litharollo tse tloaelehileng le Mehlala ea tharollo
Ho sampole ka 'ngoe eketsa 2.0 mL ea saturated ammonium pyrrolidinedithiocarbamate solution (e nang le 10g/L ea ammonium pyrrolidinedithiocarbamate) le 10.0 mL ea methyl isobutyl ketone, 'me u sisinyehe bakeng sa 30 s.Sireletsa khanyeng e khanyang.Lumella likarolo tse peli hore li arohane, 'me u sebelise methyl isobutyl ketone layer.Beha sesebelisoa ho zero u sebelisa organic layer ho tsoa ho tharollo e se nang letho.
Ka nako e tšoanang etsa qeto ea ho monyela ha lera la manyolo ho tsoa ho Mehlala bonyane makhetlo a mararo e 'ngoe le e 'ngoe.Ngola palohare ea lipalo tse tsitsitseng bakeng sa tharollo e 'ngoe le e 'ngoe ea Maemo le Sample tharollo.Pakeng tsa tekanyo e 'ngoe le e 'ngoe, hahamalla karolo ea manyolo ho tsoa tharollong e se nang letho, 'me u netefatse hore 'malo o khutlela ho zero.Rala litharollo tsa Litharollo tsa Maemo le Sample tharollo khahlano le bongata bo ekelitsoeng ba nickel.
Eketsa mola o kopanyang lintlha ho kerafo ho fihlela o kopana le axis ea mahloriso.Sebaka se pakeng tsa ntlha ena le mateano a lilepe se emela bokahare ba nickel mothapong oa Sample.
Maemo a kamohelo: NMT 1 ppm
• HO KHANYA KA HO HLAHALA <281>: NMT 0.1%, e lekantsweng ka karolo ya 1.5g
FOKOTSE TS'OANE
[HLOKOMELA-Chelete e khethiloeng tekong ena ha e ea kenyeletsoa cheleteng e baliloeng tlas'a Litšila Tse Ling Litsebisong Kakaretso.]
Tharollo ea mohlala: Hlakola 3.3 g ea Sorbitol ka 3 ml ea metsi ka thuso ea mocheso o bonolo.Pholile, 'me u kenye 20.0 mL ea cupric citrate TS le lifaha tse seng kae tsa khalase.Chesa e le hore ho belisoa ho qale ka mor'a metsotso e 4, 'me u lule u phehile bakeng sa 3 min.Fokotsa ka potlako, 'me u kenye 40 mL ea acetic acid e hlapolotsoeng, 60mL ea metsi, le 20.0 mL ea 0.05 N iodine VS.Ka ho sisinyeha ho sa khaotseng, eketsa 25 ml ea motsoako oa 6 ml ea hydrochloric acid le 94 ml ea metsi.
Analysis: Ha precipitate e qhibilihile, fokotsa bongata ba iodine ka 0.05 N sodium thiosulfate VS u sebelisa 2mL ea starch TS, e ekelitsoeng qetellong ea titration, e le pontšo.
Maemo a kamohelo: NLT 12.8 mL ea 0.05 N sodium thiosulfate VS ea hlokahala, e tsamaellanang le NMT 0.3% ea ho fokotsa tsoekere, joalo ka tsoekere.
• CHLORIDEAND SULFATE, Chloride<221> (haeba e ngotsoe bakeng sa ho sebelisoa ha ho etsoa liforomo tsa litekanyetso tsa batsoali)
Mohlala: 1.5 g
Mokhoa oa ho amohela: Mohlala ha o bontše chloride e fetang 0.10 mL ea 0.020 N hydrochloric acid (NMT 0.0050%).
• CHLORIDEAND SULFATE, Sulfate <221> (haeba e ngoletsoe ho sebelisoa ha ho etsoa liforomo tsa litekanyetso tsa batsoali)
Mohlala: 1.0 g
Maemo a ho amohela: Mohlala ha o bontše sulfate ho feta 0.10 mL ea 0.020 N sulfuric acid (NMT 0.01%).
LITEKO TSEKO
• LITEKO TSA PHAHAMO EA MICROBIAL <61> le LITEKO TSA HO KHETHA MICROORGANISMS <62>: Palo yohle ya palo ya aerobic e sebediswang ka Plate Method ke NMT 1000 cfu/g, mme kakaretso ya dipalo tse kopantsweng tsa hlobo le ditomoso ke NMT 100 cfu/g.
• PH <791>: 3.5-7.0, ka 10% (w/w) tharollo metsing a se nang carbon dioxide
• TLHALOSO EA METSI, Mokhoa oa I <921>: NMT 1.5%
CLARITYAND COLOROF SOLUTION(haeba e ngoletsoe hore e sebelisoe ho lokisetsa liforomo tsa litekanyetso tsa batsoali)
Mohlala: 10.0 g
Tlhahlobo: Qhala Mohlala ka 100.0 ml ea metsi a se nang carbon dioxide.
Mekhoa ea ho amohela: Tharollo e hlakile ebile ha e na mebala.
• TEKO YA LITHO TSA BACTERIAL ENDOTOXIN <85> (haeba e ngotswe ho sebediswa ha ho lokiswa diforomo tsa tekanyetso ya batswadi): NMT 4 USP Endotoxin Units/g bakeng sa mefuta ya ditekanyetso tsa batswadi tse nang le kgatello e ka tlase ho 100g/L ya sorbitol, le NMT 2.5 USP Endotoxin Units/g bakeng sa mefuta ea litekanyetso tsa parenteral e nang le mahloriso a 100g/L kapa ho feta a sorbitol.
KEKELETSO LIHLOKO
• PACKAGINGAND POLOKO: Boloka ka lijaneng tse koetsoeng hantle.Ha ho litlhoko tsa polokelo tse boletsoeng.
• HO PHAOLA: Sorbitol e reretsoeng ho sebelisoa ha ho etsoa liforomo tsa litekanyetso tsa batsoali li ngotsoe.
USP REFERENCE LITEKELO <11>
USP Endotoxin RS
USP Sorbitol RS