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

D-Sorbitol (CAS: 50-70-4) EP8.7 Hanyar Gwaji
D-Glucitol (D-sorbitol).
Abun ciki: 97.0 bisa dari zuwa kashi 102.0 cikin 100 (abun da ba shi da ruwa).
HALAYE
Bayyanar: fari ko kusan fari, crystalline foda.
Solubility: mai narkewa sosai a cikin ruwa, a zahiri baya narkewa a cikin ethanol (kashi 96).
Yana nuna polymorphism (5.9).
HAKORI
Alamar farko: A.
Na biyu ganewa: B, C, D
A. Bincika chromatograms da aka samu a cikin binciken.
Sakamako: babban kololuwa a cikin chromatogram da aka samu tare da maganin gwajin yayi kama da lokacin riƙewa da girman zuwa babban kololuwa a cikin chromatogram da aka samu tare da bayani na tunani (a).
B. Narke 0.5 g tare da dumama a cikin cakuda 0.5 ml na pyridine Rand 5 ml na acetic anhydride R. Bayan minti 10 zuba maganin a cikin 25 ml na ruwa Rand ba da damar tsayawa a cikin ruwan sanyi don 2 h.Hazo, recrystallised daga ƙaramin ƙarar ethanol (kashi 96 cikin ɗari) R kuma an bushe a cikin vacuo, yana narkewa (2.2.14) a 98 ℃ zuwa 104 ℃.
C. chromatography na bakin ciki (2.2.27).
Maganin gwaji.Narkar da 25 MG na abun da za a bincika a cikin ruwa R kuma a tsoma shi zuwa 10 ml tare da sauran ƙarfi iri ɗaya.
Maganin Magana (a).Narke 25 MG na sorbitol CRS a cikin ruwa R kuma a tsarma zuwa 10 ml tare da sauran ƙarfi iri ɗaya.
Maganin Magana (b).Narke 25 MG na mannitol CRS da 25 MG na sorbitol CRS a cikin ruwa R kuma a tsarma zuwa 10 ml tare da sauran ƙarfi iri ɗaya.
Plate: TLC silica gel G farantin R.
Lokacin wayar hannu: ruwa R, ethyl acetate R, propanol R (10:20:70V/V/V).
Aikace-aikace: 2 μL
Ci gaba: sama da hanyar 17cm
bushewa: cikin iska.
Ganewa: fesa tare da maganin 4-aminobenzoic acid R;bushe a cikin halin yanzu na iska mai sanyi har sai an cire acetone;zafi a 100 ℃ na 15min;ba da damar kwantar da hankali da fesa tare da 2g/L bayani na sodium periodate R;bushe a halin yanzu na iska mai sanyi;zafi a 100 ℃ na 15 min.
Dacewar tsarin: Magani na tunani (b):
- chromatogram yana nuna aibobi 2 a sarari.
Sakamako: babban tabo a cikin chromatogram da aka samu tare da maganin gwajin yana kama da matsayi, launi da girma zuwa babban tabo a cikin chromatogram da aka samu tare da bayani na tunani (a).
D. Takamaiman jujjuyawar gani (2.2.7): +4.0 zuwa +7.0 (abun anhydrou).
Narke 5.00 g na abu da za a bincika da 6.4 g na disodium tetraborate R a cikin 40 ml na ruwa R. Bada damar tsayawa don 1h, girgiza lokaci-lokaci, kuma tsarma zuwa 50.0mL da ruwa R. Tace idan ya cancanta.
GWAJI
Bayyanar bayani.Maganin a bayyane yake (2.2.1) kuma mara launi (2.2.2, Hanyar II).
Narke 5 g cikin ruwa R kuma a tsarma zuwa 50 ml tare da sauran ƙarfi iri ɗaya.
Gudanarwa (2.2.38): iyakar 20 μS · cm-1
Narkar da 20.0 g incarbon-dioxide ruwa da aka shirya daga distilled ruwa R kuma tsarma zuwa 100.0 ml tare da kaushi iri ɗaya.Auna ƙarfin aiki na maganin yayin da yake motsawa a hankali tare da mai motsawar maganadisu.
Rage sukari: matsakaicin 0.2 bisa dari, wanda aka bayyana a matsayin daidai glucose.
Narke 5.0 g a cikin 6 ml na ruwa R tare da taimakon zafi mai laushi.Cool kuma ƙara 20 ml na cupri-citric bayani R da ƴan gilashin beads.Yi zafi don fara tafasa bayan minti 4 kuma kula da tafasa don minti 3.Yi sanyi da sauri kuma ƙara 100 ml na 2.4 bisa dari V/V maganin glacial acetic acid R da 20.0 ml na 0.025 M iodine.Tare da ci gaba da girgiza, ƙara 25 ml na cakuda 6 juzu'i na hydrochloric acid R da 94 girma na ruwa R kuma, lokacin da hazo ya narkar da, titrate wuce haddi na aidin tare da 0.05 M sodium thiosulfate ta amfani da 1 ml na sitaci bayani R. zuwa ƙarshen titration, a matsayin mai nuna alama.Ba kasa da 12.8 ml na 0.05 M sodium thiosulfate ake bukata.
Abubuwan da ke da alaƙa.Liquid chromatography (2.2.29).
Maganin gwaji.Narkar da 5.0 g na abun da za a bincika a cikin 20 ml na ruwa R kuma a tsarma zuwa 100.0 ml tare da sauran ƙarfi iri ɗaya.
Maganin Magana (a).Narke 0.50g na sorbitol CRS a cikin 2 ml na ruwa R kuma a tsarma zuwa 10.0 ml tare da sauran ƙarfi iri ɗaya.
Maganin Magana (b).Tsarma 2.0ml na maganin gwajin zuwa 100.0 ml da ruwa R.
Maganin Magana (c).Tsarma 5.0 ml na maganin tunani (b) zuwa 100.0 ml da ruwa R.
Maganin Magana (d).Narkar da 0.5g na sorbitol R da 0.5 g na mannitol R (najasa A) a cikin 5 ml na ruwa R kuma a tsarma zuwa 10.0 ml tare da sauran ƙarfi iri ɗaya.
Rukunin:
– girman: l=0.3m,Ø=7.8mm
-lokacin tsaye: mai ƙarfi resin canji-canza (nauyin alli) R (9 μm);
-Zazzabi: 85± 1°C
Wayar hannu: Ruwan ruwa R.
Yawan gudu: 0.5ml/min
Ganewa: Refractometer ana kiyaye shi a madaidaicin zafin jiki (misali 35 °C).
Allura: 20μL na gwajin gwajin da mafita mafita (b) (c) da (d)
Lokacin gudu: sau biyu lokacin riƙewa na sorbitol.
Dangantakar da ke da dangantaka da sorbitol (lokacin riƙewa = game da 27 min): rashin tsabta C = game da 0.6;rashin tsarki A = kusan 0.8;rashin tsarki B = kusan 1.1.
Dacewar tsarin: mafita (d):
- ƙuduri: ƙaramar 2.0 tsakanin kololuwa saboda ƙazanta A da sorbitol.
Iyaka:
-duk wani ƙazanta: ga kowane ƙazanta, bai wuce yanki na babban kololuwa a cikin chromatogram da aka samu tare da bayani na tunani (b) (2%);
- jimlar: ba fiye da sau 1.5 na yanki na babba mafi girma a cikin chromatogram da aka samu tare da bayani na tunani (b) (3%);
- rashin kula da iyaka: yanki na babban kololuwa a cikin chromatogram da aka samu tare da bayani na tunani (c) (0.1%).
Jagora (2.4.10): matsakaicin 0.5 ppm.
Nickel (2.4.15): matsakaicin 1 ppm.
Narkar da abun da za a bincika a cikin 150.0 ml na cakuda da aka tsara.
Ruwa (2.5.12): matsakaicin 1.5 bisa dari, ƙaddara akan 1.00 g.Yi amfani da cakuda juzu'i 1 na foramide R da juzu'i 2 na methanol R mai anhydrous azaman ƙarfi.
Kwayoyin cuta na ƙwayoyin cuta
Idan an yi nufin amfani da shi wajen kera shirye-shiryen parenteral:
- TAMC: Ma'aunin yarda 102CFU/g (2.6.12).
Idan ba a yi niyya don amfani ba wajen kera shirye-shiryen parenteral:
– TAMC: ma'aunin yarda 103CFU/g (2.6.12);
- TYMC: Ma'aunin karɓa 102CFU/g (2.6.12);
- rashin Escherichia coli (2.6.13);
-Rashin Salmonella (2.6.13).
Kwayoyin endotoxins (2.6.14).Idan an yi niyya don amfani a cikin kera shirye-shiryen parenteral ba tare da ƙarin hanyar da ta dace ba don kawar da endotoxins na kwayan cuta:
- kasa da 4 IU / g don shirye-shiryen mahaifa da ke da ƙasa da 100g / l na sorbitol.
- kasa da 2.5 IU / g don shirye-shiryen parenteral tare da maida hankali na 100g / L ko fiye na sorbitol.
ASSAY
Liquid chromatography (2.2.29) kamar yadda aka bayyana a cikin gwajin abubuwan da ke da alaƙa tare da gyare-gyare mai zuwa.
Allura: maganin gwaji da maganin tunani (a).
Ƙididdige yawan adadin D-sorbitol daga abin da aka ayyana na sorbitol CRS.
LABELING
Alamar tana cewa:
- inda ya dace, matsakaicin matsakaicin ƙwayar endotoxins na kwayan cuta;
- inda ya dace, cewa abu ya dace da yin amfani da shirye-shiryen parenteral.
RASHIN ZUCIYA
A. D-mannitol,
B. D-iditol,
C.4-O-α-D-glucopyranosyl-D-glucitol (D-maltitol).

D-Sorbitol (CAS: 50-70-4) Hanyar Gwajin USP
BAYANI
Sorbitol ya ƙunshi NLT 91.0% da NMT 100.5% na D-sorbitol, ƙididdiga akan tushen anhydrous.Adadin jimillar sikari, sauran barasa na polyhydric, da kowane hexitol anhydrides, idan an gano su, ba a haɗa su cikin buƙatun ba, kuma ba a cikin adadin da aka ƙididdigewa a ƙarƙashin Sauran Najasa a cikin Bayanan Gabaɗaya.
GANO
• A.
Samfurin bayani: 1 g na sorbitol a cikin 75 ml na ruwa
Analysis: Canja wurin 3 ml na Samfurin bayani zuwa bututun gwaji na 15-cm, kuma ƙara 3 ml na sabon maganin catechol da aka shirya (1 cikin 10), da haɗuwa.Ƙara 6 ml na sulfuric acid, sa'an nan kuma a hankali zafi bututu a cikin harshen wuta na 30 s.
• B. Lokacin riƙewa na babban kololuwar samfurin samfurin ya dace da wancan daga daidaitaccen bayani, kamar yadda aka samu a cikin Assay.
ASSAY
• TSARI
Lokacin wayar hannu: Yi amfani da ruwan da aka cire.
Maganin dacewa da tsarin: Shirya bayani mai ɗauke da 4.8 mg/g na kowane USP Sorbitol RS da mannitol
Daidaitaccen bayani: 4.8 MG / g na USP Sorbitol RS
Maganin samfurin: Narke 0.10 g na Sorbitol a cikin ruwa, kuma a tsoma shi da ruwa zuwa 20g.Yi rikodin nauyin bayani na ƙarshe, kuma haɗuwa sosai.
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsarin.)
Yanayin: LC
Mai ganowa: Fihirisar Refractive
Tushen: 7.8-mm x 10-cm;Farashin L34
Zazzabi
Shafin: 50± 2°
Mai ganowa: 35°
Yawan gudana: 0.7 ml/min
Girman allura: 10 μL
Dacewar tsarin
Samfurori: Maganin dacewa da tsarin da daidaitaccen bayani [NOTE-Lokacin riƙe dangi na mannitol da sorbitol kusan 0.6 da 1.0 ne, bi da bi.]
Abubuwan da suka dace
Resolution: NLT 2.0 tsakanin sorbitol da mannitol, Tsarin dacewa da tsarin
Matsakaicin daidaitaccen dangi: NMT 2.0%, Daidaitaccen bayani
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Yi ƙididdige adadin, bisa tushen anhydrous, na D-sorbitol a cikin sashin da aka ɗauka na Sorbitol:
Sakamako = (rU/rS) x (CS/CU) x (100/ (100 -W)) x 100
rU= kololuwar amsa daga Maganin Samfurin
rS= kololuwar amsa daga daidaitaccen bayani
CS = maida hankali na USP Sorbitol RS a cikin daidaitaccen bayani (mg/g)
CU = maida hankali na Sorbitol a cikin Sample bayani (mg/g)
W= kashi da aka samu a cikin gwajin Ƙaddamar Ruwa
Sharuɗɗan karɓa: 91.0% -100.5% akan tushen anhydrous
RASHIN ZUCIYA
• IYAKA NICKE
Maganin samfurin: Narke 20.0 g na Sorbitol a cikin diluted acetic acid, da kuma tsarma da diluted acetic acid zuwa 150 ml.
Maganin Blank: 150 ml na diluted acetic acid
Daidaitaccen mafita: Shirya mafita guda uku ta ƙara 0.5, 1.0, da 1.5 ml na daidaitaccen bayani na nickel TS zuwa 20.0 g na Sorbitol wanda aka narkar da shi a cikin diluted acetic acid, kuma a tsarma da sauran ƙarfi zuwa 150 ml.
Yanayin kayan aiki
(Duba Spectrophotometry da Haske- Watsawa <851>)
Yanayin: Atomic absorption spectrophotometry
Tsawon Nazari: 232.0 nm
Lamba: Nickel hollow-cathode
Harshen wuta: Air-acetylene
Bincike
Samfurori: Daidaitaccen mafita da Samfurin bayani
Ga kowane samfurin ƙara 2.0 ml na cikakken ammonium pyrrolidinedithiocarbamate bayani (wanda ya ƙunshi 10g/L na ammonium pyrrolidinedthiocarbamate) da 10.0 ml na methyl isobutyl ketone, kuma girgiza don 30 s.Kare daga haske mai haske.Bada yadudduka biyu su rabu, kuma amfani da methyl isobutyl ketone Layer.Saita kayan aikin zuwa sifili ta amfani da Layer Layer daga Maganin Blank.
Daidaita ƙayyadaddun abubuwan sha na Layer na halitta daga Samfuran aƙalla sau uku kowanne.Yi rikodin matsakaicin tsayuwar karatun don kowane Madaidaicin mafita da Maganin Samfurin.Tsakanin kowane ma'auni, zazzage Layer na halitta daga Maganin Blank, kuma tabbatar da cewa karatun ya koma sifili.Yi ƙirƙira abubuwan sha na daidaitattun hanyoyin magancewa da Samfurin bayani tare da ƙarin adadin nickel.
Extrapolate layin da ke haɗa maki akan jadawali har sai ya hadu da axis.Nisa tsakanin wannan batu da tsaka-tsakin gatari yana wakiltar ƙaddamar da nickel a cikin samfurin samfurin.
Sharuɗɗan karɓa: NMT 1 ppm
• RASHIN WUTA <281>: NMT 0.1%, an ƙaddara akan wani yanki na 1.5g
RAGE SUGAR
[NOTE- Adadin da aka ƙayyade a cikin wannan gwajin ba a haɗa shi cikin adadin da aka ƙididdigewa a ƙarƙashin Wasu ƙazanta a cikin Babban Sanarwa.]
Maganin samfurin: Narke 3.3 g na Sorbitol a cikin 3 ml na ruwa tare da taimakon zafi mai laushi.Cool, kuma ƙara 20.0 ml na cupric citrate TS da ƴan gilashin beads.Yi zafi don fara tafasa bayan minti 4, kuma kula da tafasa don minti 3.Yi sanyi da sauri, kuma ƙara 40 ml na diluted acetic acid, 60 ml na ruwa, da 20.0 ml na 0.05 N aidin VS.Tare da ci gaba da girgiza, ƙara 25 ml na cakuda 6 ml na hydrochloric acid da 94 ml na ruwa.
Analysis: Lokacin da hazo ya narkar da, titrate wuce haddi na aidin tare da 0.05 N sodium thiosulfate VS ta amfani da 2mL na sitaci TS, ƙara zuwa ƙarshen titration, a matsayin mai nuna alama.
Sharuɗɗan karɓa: NLT 12.8 ml na 0.05 N sodium thiosulfate VS ana buƙatar, daidai da NMT 0.3% na rage sukari, azaman glucose.
• CHLORIDEAND SULFATE, Chloride <221> (idan an lakafta shi don amfani wajen shirya fom ɗin adadin mahaifa)
Misali: 1.5 g
Sharuɗɗan karɓa: Samfuran ya nuna babu ƙarin chloride fiye da daidai da 0.10 ml na 0.020 N hydrochloric acid (NMT 0.0050%).
• CHLORIDEAND SULFATE, Sulfate <221> (idan an lakafta shi don amfani a cikin shirya nau'ikan sashi na mahaifa)
Misali: 1.0 g
Sharuɗɗan karɓa: Samfurin ya nuna babu sulfate fiye da daidai da 0.10 ml na 0.020 N sulfuric acid (NMT 0.01%).
MAKAMMAN JARRABAWA
• GWAJIN KIMIYYAR MICROBIAL <61> da GWAJI GA MATSALOLIN MICROORGANISMS <62>: Jimlar aerobic ƙidaya ta amfani da Hanyar farantin karfe shine NMT 1000 cfu/g, kuma jimlar ƙwanƙwasawa da yeasts ƙidaya NMT 100 cfu/g
• PH <791>: 3.5-7.0, a cikin 10% (w / w) bayani a cikin ruwa maras carbon dioxide
• SANARWA RUWA, Hanyar I <921>: NMT 1.5%
MAGANIN CLARITY DA COLOROF (idan an yi masa laƙabi don amfani wajen shirya fom ɗin allurai na mahaifa)
Misali: 10.0 g
Nazari: Narkar da Samfurin a cikin 100.0 ml na ruwan da ba shi da carbon dioxide.
Sharuɗɗan karɓa: Maganin a bayyane yake kuma mara launi.
• GWAJIN BACTERIAL ENDOTOXINS <85> (idan an lakafta shi don amfani a shirya nau'ikan sashi na mahaifa): NMT 4 USP Endotoxin Units / g don nau'ikan nau'ikan nau'ikan nau'ikan mahaifa da ke da ƙarancin ƙasa da 100g/L na sorbitol, da NMT 2.5 USP Endotoxin Units/g Don nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan suna da maida hankali na 100g/L ko fiye na sorbitol.
KARIN BUKATA
MAKIYYA DA KYAUTA: Ajiye a cikin kwantena masu kyau.Babu buƙatun ajiya da aka ƙayyade.
LABELING: Sorbitol da aka yi niyya don amfani da shi wajen shirya fom ɗin allurai na mahaifa yana da alamar haka.
MATSAYIN NAZARI NA USP <11>
USP Endotoxin RS
USP Sorbitol RS