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

D-Sorbitol (CAS: 50-70-4) EP8.7 Test Method
D-Glucitol (D-sorbitol).
Zvemukati: 97.0 muzana kusvika 102.0 muzana (anhydrous substance).
VANHU
Kuonekwa: chena kana inenge yakachena, crystalline powder.
Solubility: yakanyanya kunyungudika mumvura, isinganyungudika mu ethanol (96 muzana).
Inoratidza polymorphism (5.9).
DENTIFICATION
Kuzivikanwa kwekutanga: A.
Chechipiri kuzivikanwa: B, C, D
A. Ongorora machromatograms akawanikwa muyedzo.
Mhedzisiro: iyo yepamusoro peak muchromatogram yakawanikwa nemhinduro yebvunzo yakafanana mukuchengetedza nguva uye saizi kune yepamusoro peak muchromatogram yakawanikwa nereferensi mhinduro (a).
B. Dissolve 0.5 g nekudziya musanganiswa we 0.5 mL yepyridine Rand 5 mL yeacetic anhydride R. Mushure memaminitsi gumi dururira mushonga mu 25 mL yemvura Rand bvumira kumira mumvura yechando kwemaawa maviri.Iyo precipitate, yakadzokororwa kubva padiki vhoriyamu ethanol (96 muzana) R uye yakaomeswa muvacuo, inonyunguduka (2.2.14) pa98 ℃ kusvika 104 ℃.
C. Thin-layer chromatography (2.2.27).
Test mhinduro.Dissolve 25 mg yechinhu chinofanirwa kuongororwa mumvura R uye dilute kusvika ku10 mL neine solvent yakafanana.
Reference solution (a).Dissolve 25 mg ye sorbitol CRS mumvura R uye shandura kusvika ku10 mL neine solvent yakafanana.
Reference solution (b).Dissolve 25 mg ye mannitol CRS uye 25 mg ye sorbitol CRS mumvura R uye deredza kusvika ku 10 mL neine solvent yakafanana.
Plate: TLC silica gel G ndiro R.
Nharembozha: mvura R, ethyl acetate R, propanol R (10:20:70V/V/V).
Kushandisa: 2 μL
Kubudirira: pamusoro penzira ye17cm
Kuomesa: mumhepo.
Kuona: pfapfaidza ne 4-aminobenzoic acid mhinduro R;yakaoma mumhepo inotonhora kusvikira acetone yabviswa;kupisa pa100 ℃ kwe15min;bvumira kutonhora uye kupfapfaidza ne 2g / L solution ye sodium periodate R;yakaoma mumhepo inotonhora;kupisa pa100 ℃ kwemaminitsi gumi nemashanu.
Kukodzera kweSystem: Reference solution (b):
- chromatogram inoratidza 2 mavara akaparadzaniswa zvakajeka.
Mhedzisiro: nzvimbo huru muchromatogram yakawanikwa nemhinduro yebvunzo yakafanana pachinzvimbo, ruvara uye saizi kunzvimbo huru muchromatogram yakawanikwa nereferensi mhinduro (a).
D. Yakananga optical rotation (2.2.7): +4.0 kusvika +7.0 (anhydrou substance).
Dissolve 5.00 g yechinhu chinofanirwa kuongororwa uye 6.4 g ye disodium tetraborate R mu 40 mL yemvura R. Bvumira kumira kwe 1h, ichizunungusa apo neapo, uye dilute kusvika 50.0mL nemvura R. Sefa kana zvichidikanwa.
ZVIYEDZO
Kuonekwa kwemhinduro.Chigadziriswa chakajeka (2.2.1) uye chisina ruvara (2.2.2, Method II).
Dissolve 5 g mumvura R uye dilute kusvika 50 mL neine solvent yakafanana.
Conductivity (2.2.38): yakawanda 20 μS · cm-1
Dissolve 20.0 g incarbon dioxide-isina mvura R yakagadzirwa kubva mumvura yakanyungudutswa R uye dilute kusvika ku100.0 mL neine solvent yakafanana.Edza conductivity yemhinduro uchikurudzira zvinyoronyoro nemagnetic stirrer.
Kuderedza shuga: yakawanda 0.2 muzana, inoratidzirwa seglucose yakaenzana.
Dissolve 5.0 g mu 6 mL yemvura Rnekubatsira kwekupisa kunyoro.Tonhodza wowedzera 20 mL yecupri-citric solution R uye magirazi mashoma.Kupisa kuitira kuti kufashaira kutange mushure me4 min uye chengetedza kuvira kwemaminetsi matatu.Poira nekukasira wowedzera 100 mL ye2.4 per cent V/V solution yeglacial acetic acid R uye 20.0 mL ye0.025 M iodine.Nekuzununguka kunoramba kuchienderera, wedzera 25 mL yemusanganiswa we6 mavhoriyamu ehydrochloric acid R uye 94 vhoriyamu yemvura R uye, kana mvura yanyungudika, wedzera iyo iodine yakawandisa ne 0.05 M sodium thiosulfate uchishandisa 1 mL ye starch solution R, wakawedzera. kusvika kumagumo etitration, sechiratidzo.Kwete pasi pe12.8 mL ye0.05 M sodium thiosulfate inodiwa.
Zvinoenderana zvinhu.Liquid chromatography (2.2.29).
Test mhinduro.Dissolve 5.0 g yechinhu chinofanira kuongororwa mu 20 mL yemvura R uye dilute kusvika ku 100.0 mL neine solvent yakafanana.
Reference solution (a).Dissolve 0.50g ye sorbitol CRS mu 2 mL yemvura R uye wedzera kusvika ku10.0 mL neine solvent yakafanana.
Reference solution (b).Dilute 2.0mL yemhinduro yebvunzo kusvika ku100.0 mL nemvura R.
Reference solution (c).Dilute 5.0 mL yereferensi mhinduro (b) kusvika 100.0 mL nemvura R.
Reference solution (d).Dissolve 0.5g ye sorbitol R uye 0.5 g ye mannitol R (kusvibiswa A) mu 5 mL yemvura R uye shandura kusvika ku10.0 mL neine solvent yakafanana.
Column:
-saizi:l=0.3m,Ø=7.8mm
-stationary phase: yakasimba cation-exchange resin (calcium fomu) R (9 μm);
-tembiricha: 85±1°C
Nharembozha chikamu: degassed mvura R.
Kuyerera kweyero: 0.5mL/min
Kuonekwa: refractometer inochengetwa patembiricha isingaperi (semuenzaniso 35 ° C).
Jekiseni: 20μL yebvunzo mhinduro uye referenzi mhinduro (b) (c) uye (d)
Nguva yekumhanya: kaviri nguva yekuchengetedza ye sorbitol.
Kuchengetwa kwehukama maererano ne sorbitol (nguva yekuchengetedza = inenge 27 min): tsvina C = inenge 0.6;tsvina A = inenge 0.8;kusachena B = anenge 1.1.
Kukodzera kweSystem: Reference solution (d):
-resolution: shoma 2.0 pakati pepamusoro nekuda kwekusachena A uye sorbitol.
Miganhu:
-chero kusachena: kune imwe neimwe kusachena, kwete kupfuura nzvimbo yepamusoro peak muchromatogram yakawanikwa nereferensi mhinduro (b) (2 muzana);
-total: isingasviki 1.5 nguva yenzvimbo yepamusoro peak muchromatogram yakawanikwa nereferensi mhinduro (b) (3 muzana);
-kuregeredza muganho: iyo nzvimbo yepamusoro peak muchromatogram yakawanikwa nereferensi mhinduro (c) (0.1 muzana).
Kutungamira (2.4.10): yakawanda 0.5 ppm.
Nickel (2.4.15): yakawanda 1 ppm.
Dissolve the substance kuti iongororwe mu 150.0 mL yemusanganiswa wakatemerwa wezvinonyungudutsa.
Mvura (2.5.12): yakawanda 1.5 muzana, yakatemwa pa 1.00 g.Shandisa musanganiswa we1vhoriyamu yeformamide R uye 2 mavhoriyamu eanhydrous methanol R se solvent.
Microbial kusvibiswa
Kana yakagadzirirwa kushandiswa mukugadzirwa kwevabereki kugadzirira:
- TAMC: chiyero chekugamuchira 102CFU / g (2.6.12).
Kana isina kuitirwa kushandiswa mukugadzirwa kwevabereki kugadzirira:
- TAMC: chirevo chekugamuchira 103CFU / g (2.6.12);
- TYMC: chiyero chekugamuchira 102CFU / g (2.6.12);
-kusavapo kweEscherichia coli (2.6.13);
-kusavapo kweSalmonella (2.6.13).
Bhakitiriya endotoxins (2.6.14).Kana yakagadzirirwa kushandiswa mukugadzirwa kwevabereki kugadzirira pasina imwe nzira yakakodzera yekubvisa bhakitiriya endotoxins:
- isingasviki 4 IU / g yegadziriro yevabereki ine huwandu husingasviki 100g/L ye sorbitol.
- isingasviki 2.5 IU/g yevabereki gadziriro ine muunganidzwa we100g/L kana kupfuura sorbitol.
ASSAY
Liquid chromatography (2.2.29) sekutsanangurwa kwazvinoitwa muyedzo yezvinhu zvine hukama neshanduko inotevera.
Jekiseni: bvunzo mhinduro uye referensi mhinduro (a).
Verenga huwandu hwehuwandu hweD-sorbitol kubva pane zvakaziviswa zve sorbitol CRS.
LABELING
The label inoti:
- pazvinenge zvakakodzera, kuwanda kwakanyanya kwebhakitiriya endotoxins;
- pazvinenge zvakakodzera, kuti chinhu chacho chakakodzera kushandiswa kwekugadzirwa kwevabereki.
KUSIRIRA
A. D-mannitol,
B. D-iditol,
C. 4-O-α-D-glucopyranosyl-D-glucitol (D-maltitol).

D-Sorbitol (CAS: 50-70-4) USP Test Method
DEFINITION
Sorbitol ine NLT 91.0% uye NMT 100.5% yeD-sorbitol, inoverengwa pane anhydrous basis.Huwandu hweshuga dzakakwana, mamwe mapolyhydric alcohols, uye chero hexitol anhydrides, kana ikaonekwa, haina kubatanidzwa mune zvinodiwa, kana muhuwandu hwakaverengerwa pasi peKumwe Kusvibiswa mune General Notices.
KUZIVA
• A.
Mhinduro yemuenzaniso: 1g yeSorbitol mu 75 mL yemvura
Ongororo: Tumira 3 mL yeSample solution kune 15-cm test chubhu, uye wedzera 3 mL yemushonga wekatechol uchangogadzirwa (1 mu10), wosanganisa.Wedzera 6 mL ye sulfuric acid, wobva wapisa zvinyoro nyoro chubhu mumurazvo we30 s.
• B. Nguva yekuchengeta yenhongonya huru yeSample solution inoenderana neiyo kubva kuStandard solution, sezvakawanikwa muAssay.
ASSAY
• MAITIRO
Nharembozha: Shandisa mvura yakabviswa gasi.
Sistimu yakakodzera mhinduro: Gadzirira mhinduro ine 4.8 mg/g yega yega USP Sorbitol RS uye mannitol
Mushonga wakakwana: 4.8 mg/g yeUSP Sorbitol RS
Sample solution: Dissolve 0.10 g yeSorbitol mumvura, uye wedzera nemvura kusvika 20g.Nyora uremu hwekupedzisira hwekugadzirisa, uye nyatsosanganisa.
Chromatographic system
(Ona Chromatography <621>, System Suitability.)
Modhi: LC
Detector: Refractive index
Column: 7.8-mm x 10-cm;kurongedza L34
Tembiricha
Column: 50±2°
Detector: 35 °
Kuyerera kweyero: 0.7 mL/min
Jekiseni saizi: 10 μL
Kukodzera kwehurongwa
Samples: Kukodzera kweSystem solution uye Standard solution [Cherechedza-Nguva dzekuchengeta mannitol nesorbitol dzinenge 0.6 uye 1.0, zvichiteerana.]
Kukodzera zvinodiwa
Kugadziriswa: NLT 2.0 pakati pe sorbitol uye mannitol, Sistimu yakakodzera mhinduro
Relative mwero kutsauka: NMT 2.0%, Standard solution
Analysis
Samples: Yakajairwa mhinduro uye Sample mhinduro
Verengai muzana, pane anhydrous base, yeD-sorbitol muchikamu cheSorbitol chakatorwa:
Mhedzisiro = (rU/rS) x (CS/CU) x (100/(100 -W)) x 100
rU= peak mhinduro kubva kuSample solution
rS= peak mhinduro kubva kune Standard solution
CS= kuungana kweUSP Sorbitol RS muiyo Standard mhinduro (mg/g)
CU = kusangana kweSorbitol muSample solution (mg/g)
W = muzana yakawanikwa muyedzo yeKutsunga Mvura
Maitiro ekugamuchira: 91.0% -100.5% pane anhydrous basis
KUSIRIRA
• LIMITOF NICKE
Sample solution: Dissolve 20.0 g yeSorbitol in diluted acetic acid, wobva wanyungudusa nediluted acetic acid kusvika pa150 mL.
Mhinduro isina chinhu: 150 mL ye diluted acetic acid
Mishonga yakajairwa: Gadzirira mhinduro nhatu nekuwedzera 0.5, 1.0, uye 1.5 mL yenickel standard solution TS kusvika 20.0 g yeSorbitol yakanyungudutswa mudiluted acetic acid, uye dilute neinonyungudutsa yakafanana kusvika pa150 mL.
Zviridzwa mamiriro
(Ona Spectrophotometry uye Chiedza-Kuparadzira <851>)
Mode: Atomic absorption spectrophotometry
Analytical wavelength: 232.0 nm
Mwenje: Nickel hollow-cathode
Moto: Air-acetylene
Analysis
Samples: Yakajairwa mhinduro uye Sample mhinduro
Kumuenzaniso wega wega wedzera 2.0 mL ye saturated ammonium pyrrolidinedithiocarbamate solution (ine 10g/L yeammonium pyrrolidinedithiocarbamate) uye 10.0 mL yemethyl isobutyl ketone, uye zunza kwe30 s.Dzivirira kubva kuchiedza chakajeka.Bvumira zvidimbu zviviri kuti zviparadzanise, uye shandisa methyl isobutyl ketone layer.Isa chiridzwa kusvika zero uchishandisa iyo organic layer kubva kuBlank solution.
Concomitant kuona kunyura kweiyo organic layer kubva kumaSamples kanokwana katatu imwe neimwe.Rekodha avhareji yekuverenga kwakatsiga kune imwe neimwe yeStandard mhinduro uye Sample mhinduro.Pakati peyero yega yega, shuvira iyo organic layer kubva kuBlank mhinduro, uye ona kuti kuverenga kunodzokera ku zero.Ronga kunyura kweiyo Standard mhinduro uye Sample solution maringe nekuwedzera huwandu hwenickel.
Wedzera mutsara uchijoinha mapoinzi pagirafu kusvika wasangana neaxis yeconcentration.Chinhambwe chiri pakati peiyi poindi uye pamharadzano yematemo chinomiririra kuwanda kwenickel muSample solution.
Maitiro ekugamuchira: NMT 1 ppm
• KUBATSIRA KWASARA <281>: NMT 0.1%, yakatemwa pachikamu che1.5g
KUDZORERA MASUGA
[Cherechedza-Iyo mari yakatsanangurwa muyedzo iyi haina kuverengerwa muhuwandu hwakaverengerwa pasi peKumwe Kusvibiswa muZviziviso Zvakawanda.]
Sample solution: Dissolve 3.3 g yeSorbitol mu 3 mL yemvura nerubatsiro rwekupisa zvinyoro.Kutonhorera, uye wedzera 20.0 mL ye cupric citrate TS uye mashoma magirazi mabhero.Kupisa kuitira kuti kufashaira kutange mushure me4 min, uye chengetedza kuvira kwemaminetsi matatu.Poira nekukasira, woisa 40 mL yediluted acetic acid, 60 mL yemvura, uye 20.0 mL ye0.05 N iodine VS.Nekuzunungusa nguva dzose, wedzera 25 mL yemusanganiswa we6 mL yehydrochloric acid uye 94 mL yemvura.
Kuongorora: Kana mvura yanyunguduka, titrate yakawandisa yeiodine ne 0.05 N sodium thiosulfate VS uchishandisa 2mL ye starch TS, yakawedzerwa kusvika kumagumo etitration, sechiratidzo.
Maitiro ekugamuchira: NLT 12.8 mL ye0.05 N sodium thiosulfate VS inodiwa, inoenderana neNMT 0.3% yekudzikisa shuga, seglucose.
• CHLORIDEAND SULFATE, Chloride<221> (kana yakanyorwa kuti ishandiswe mukugadzira mafomu ekuyerwa kwevabereki)
Muenzaniso: 1.5 g
Maitiro ekugamuchira: Muenzaniso hauratidze chloride inopfuura 0.10 mL ye0.020 N hydrochloric acid (NMT 0.0050%).
• CHLORIDEAND SULFATE, Sulfate <221> (kana yakanyorwa kuti ishandiswe mukugadzira mafomu ekuyerwa kwevabereki)
Muenzaniso: 1.0 g
Maitiro ekugamuchira: Muenzaniso unoratidza kusave nesarufa kupfuura kuenderana ne0.10 mL ye0.020 N sulfuric acid (NMT 0.01%).
ZVIYEDZO ZVAKANAKA
• MICROBIAL ENUMERATION TESTS <61> uye ZVIYEdzo ZVAKATAURWA MICROORGANISMS <62>: Huwandu hweaerobiki uchishandisa Plate Method iNMT 1000 cfu/g, uye huwandu hwakasanganiswa hweforoma nembiriso iNMT 100 cfu/g.
• PH <791>: 3.5-7.0, mune 10% (w/w) mhinduro mumvura isina carbon dioxide
• KUTARISA MVURA, Nzira I <921>: NMT 1.5%
CLARITYAND COLOROF SOLUTION (kana yakanyorwa kuti ishandiswe mukugadzira mafomu eparenteral dosage)
Muenzaniso: 10.0 g
Kuongorora: Dissolve Sample mu100.0 mL yemvura isina carbon dioxide.
Maitiro ekugamuchira: Mhinduro yakajeka uye isina ruvara.
• BACTERIAL ENDOTOXINS TEST <85> (kana yakanyorwa kuti ishandiswe mukugadzira mafomu ekupimowa kwevabereki): NMT 4 USP Endotoxin Units/g yemapiritsi emafomu emupimo ane kusanganisirwa kuri pasi pe100g/L ye sorbitol, uye NMT 2.5 USP Endotoxin Units/g kune parenteral dosage mafomu ane muunganidzwa we100g/L kana kupfuura ye sorbitol.
ZVIMWE ZVINODIWA
• PACKAGINGAND STORAGE: Chengetedza mumidziyo yakavharwa zvakanaka.Hapana kuchengetedza zvinodiwa zvinotsanangurwa.
• KUITA MALEBHORO: Sorbitol yakagadzirirwa kushandiswa kugadzira mafomu ekuyerwa kwevabereki yakanyorwa kudaro.
USP REFERENCE MITIRO <11>
USP Endotoxin RS
USP Sorbitol RS