I-Glycine CAS 56-40-6 (H-Gly-OH) Isivivinyo 98.5~101.5% Ifektri Yekhwalithi Ephezulu

I-USP35-NF30
INCAZELO
I-Glycine iqukethe i-NLT 98.5% kanye ne-NMT 101.5% ye-glycine (C2H5NO2), ebalwa ngokomiswa.
UKUKHOMBA
A. UKUMUMWA KWE-INFRARED <197M>
ISIVIVINYO
• INQUBO
Isampula: 150 mg yeGlycine
Okungenalutho: 100 mL we-glacial acetic acid
Isistimu ye-Titrimetric
(Bheka i-Titrimetry <541>.)
Imodi: I-titration eqondile
I-Titrant: 0.1 N nge-chloric acid VS
Ukutholwa kwendawo yokugcina: Okubonakalayo
Ukuhlaziya: Chaza Isampula ku-100 mL we-glacial acetic acid, bese wengeza iconsi elingu-1 le-crystal violet TS.Titrate nge-Titrant iye endaweni yokugcina eluhlaza.Yenza ukuzimisela Okungenalutho.
Bala iphesenti le-glycine (C2H5NO2) Kusampula ethathiwe:
Umphumela = {[(VS − VB) × N × F]/W} × 100
I-VS = Ivolumu ye-Titrant esetshenziswe Isampula (mL)
I-VB = Ivolumu ye-Titrant edliwe yi-Blank (mL)
N = ukujwayelekile kwangempela kwe-Titrant (mEq/mL)
F = i-equivalency factor, 75.07 mg/mEq
W = Isisindo sesampula (mg)
Indlela yokwamukela: 98.5% -101.5% ngesisekelo esomisiwe
UKUNGCOLA
• INSALELA EKUSHIYENI <281>: NMT 0.1%
• I-CHLORIDE NE-SULFATE, I-Chloride <221>
Isixazululo esijwayelekile: 0.10 mL ka-0.020 N hydrochloric acid
Isampula: 1 g ye-Glycine
Indlela yokwamukela: NMT 0.007%
• I-CHLORIDE NE-SULFATE, i-Sulfate <221>
Isixazululo esijwayelekile: 0.20 mL ka-0.020 N sulfuric acid
Isampula: 3 g we-Glycine
Indlela yokwamukela: NMT 0.0065%
• IZIMTHETHO EZISINDAYO, Indlela I <231>: NMT 20 ppm
• IZIMTHETHO EZISINDAYO, Indlela I <231>: NMT 20 ppm
Isixazululo sesampula: 100 mg/mL yeGlycine
Ukuhlaziya: Bilisa u-10 mL wesixazululo Sesampula iminithi elingu-1, bese ubeke eceleni amahora ama-2.
Indlela yokwamukela: Isixazululo sibonakala sicacile futhi sihamba njengo-10 mL wesisombululo esifanayo esingakabiliswa.
IZIVIVINYO EZITHILE
• UKULAHLEKELWA EKOMISENI <731>: Yomisa isampula ku-105° amahora angu-2: ilahlekelwa yi-NMT 0.2% yesisindo sayo.
IZIDINGO EZENGEZIWE
• UKUPAKASHA KANYE NESIGCINI: Londoloza ezitsheni ezivalwe kahle.
• AMAZINGA EREferensi e-USP <11>
USP Glycine RS

I-Japan Pharmacopoeia JP17
I-Glycine, uma yomisiwe, iqukethe okungenani ama-98.5% e-Glycine(C2H5NO2).
I-Glycine ivela imhlophe, i-crystalline powder noma i-crystalline powder.Inokunambitheka okumnandi.Incibilika ngokukhululeka emanzini naku-asidi ye-formic, futhi ayincibiliki ku-ethanol (95).Ibonisa i-crystal polymorphism.
Ukuhlonza Thola i-spectrum yokumuncwa kwe-infrared ye-Glycine, omiswe ngaphambilini, njengoba kuqondiswe endleleni yediski ye-potassiumbromide ngaphansi kwe-Infrared Spectrophotometry <2.25>, bese uqhathanisa i-spectrum ne-Reference Spec-trum: zombili izibukeli zibonisa ukuqina okufanayo kokumuncwa ngezinombolo zamagagasi afanayo.Uma kukhona umehluko ovela phakathi kwe-spectra, ncibilikisa i-Glycine emanzini, uhwamulise ukoma kwamanzi, bese uphinda ukuhlolwa nensalela.
pH <2.54> Chaza u-1.0 g we-Glycine ku-20 mL wamanzi: i-thepH yesisombululo iphakathi kuka-5.6 no-6.6.
Ubumsulwa
(1) Ukucaca kanye nombala wesixazululo-Dissolve 1.0 gof Glycine ku-10 mL wamanzi: ikhambi licacile futhi alinawo umbala.
(2) I-Chloride <1.03>-Yenza ukuhlolwa nge-0.5 g ye-Glycine.Lungiselela ikhambi lokulawula ngo-0.30 mL we-0.01mol/L hydrochloric acid VS (hhayi ngaphezu kuka-0.021%)
(3) I-Sulfate <1.14>-Yenza ukuhlolwa nge-0.6 g ye-Glycine.Lungiselela ikhambi lokulawula ngo-0.35 mL we-0.005mol/L sulfuric acid VS (hhayi ngaphezu kuka-0.028z).
(4) I-Ammonium <1.02>-Yenza ukuhlola usebenzisa i-0.25 g ye-Glycine.Lungiselela ikhambi lokulawula ngo-5.0 mL we-Standard Ammonium Solution (hhayi ngaphezu kuka-0.02%).
(5) Izinsimbi Ezisindayo <1.07>-Qhubeka no-1.0 g weGlycine ngokweNdlela 1, futhi wenze ukuhlolwa.Lungiselela isixazululo sokulawula ngo-2.0 mL Wesixazululo Esijwayelekile Sokuhola (hhayi ngaphezu kuka-20 ppm).
(6) I-Arsenic <1.11>-Lungisa isixazululo sokuhlola nge-1.0 gof Glycine ngokweNdlela 1, futhi wenze ukuhlolwa (hhayi ngaphezu kuka-2 ppm).
(7) Izinto Ezihlobene Nazo-Chaza u-0.10 g we-Glycine ku-25mL wamanzi futhi usebenzise lesi sixazululo njengesixazululo sesampula.Ipayipi elingu-1 mL lesixazululo sesampula, engeza amanzi ukwenza ama-mL angama-50.Ipayipi elingu-5 mL lalesi sixazululo, engeza amanzi ukwenza u-20 mL ngqo, futhi usebenzise lesi sixazululo njengesixazululo esijwayelekile.Yenza ukuhlola ngalezi zixazululo njengoba uqondiswe ngaphansi kwe-Thin-layer Chromatography<2.03>.Faka i-5mL ngayinye yesixazululo sesampula nesisombululo esijwayelekile epuletini lejeli ye-silica forthin-layer chromatography.Yakha ipuleti ngengxube ye-1-butanol, amanzi ne-acetic acid (100) (3:1:1) ukuya ebangeni elingama-cm ayi-10, bese womisa ipuleti ku-80℃ imizuzu engama-30.Fafaza ngokulinganayo isixazululo se-ninhydrin ku-acetone (1 ku-50), futhi ushise ku-80℃ imizuzu emi-5: amachashaza ngaphandle kwendawo eyinhloko evela kusixazululo sesampula awashubi kakhulu kunendawo evela esixazululweni esivamile.
Ukulahlekelwa Ekumisweni <2.41> Hhayi ngaphezulu kuka-0.30% (1 g, 105℃, amahora angu-3).
Insalela Ekuthutheni <2.44> Ayidluli ku-0.10% (1g).
I-Assay Kala ngokunembile cishe u-80 mg we-Glycine, omisiwe ngaphambilini, ncibilika ku-3 mL we-formic acid, engeza u-50 mL we-acetic acid (100), kanye ne-titrate <2.50> nge-0.1 mol/L perchloric acid VS (potentiometric titration).Yenza i-determi-nation engenalutho, futhi wenze noma yikuphi ukulungisa okudingekayo.
I-mL ngayinye ka-0.1 mol/L perchloric acid VS＝7.507 mg ye-C2H5NO2
Iziqukathi nokugcina Iziqukathi-Iziqukathi ezivalwe Kahle.