I-Glycine CAS 56-40-6 (H-Gly-OH) i-Assay 98.5 ~ 101.5% iFactory High Quality

USP35-NF30
INGCACISO
I-Glycine iqulethe i-NLT 98.5% kunye ne-NMT 101.5% ye-glycine (C2H5NO2), ibalwe ngokomisiweyo.
UKUCHAZA
A. UKUFUTSHWA KWE-IFRARED <197M>
UVAVANYO
• INKQUBO
Isampulu: 150 mg yeGlycine
Akunanto: 100 mL ye-acetic acid yeglacial
Inkqubo yeTitrimetric
(Jonga i-Titrimetry <541>.)
Imowudi: Ukubhalwa ngokuthe ngqo
I-Titrant: 0.1 N nge-asidi ye-chloric VS
Ukubonwa kwendawo yokugqibela: Okubonakalayo
Uhlalutyo: Chitha iSampulu kwi-100 mL ye-glacial acetic acid, kwaye ungeze i-1 drop of crystal violet TS.Titrate ngeTitrant ukuya kwindawo eluhlaza.Yenza ukuzimisela kweGank.
Bala ipesenti ye-glycine (C2H5NO2) kwiSampuli ethathiweyo:
Isiphumo = {[(VS − VB) × N × F]/W} × 100
VS = Umthamo we-Titrant osetyenziswe yiSampuli (mL)
VB = Umthamo we-Titrant odliwe yi-Gank (mL)
N = ukuqheleka okwenyani kweTitrant (mEq/mL)
F = i-equivalency factor, i-75.07 mg / mEq
W = Ubunzima besampulu (mg)
Indlela yokwamkela: 98.5% -101.5% kwisiseko esomileyo
UBUNGCOLA
• INTSALELA YOKUBASA <281>: NMT 0.1%
• I-CHLORIDE NE-SULFATE, i-Chloride <221>
Isisombululo esisemgangathweni: 0.10 mL ye-0.020 N i-hydrochloric acid
Isampuli: 1 g yeGlycine
Indlela yokwamkelwa: NMT 0.007%
• I-CHLORIDE NE-SULFATE, i-Sulfate <221>
Isisombululo esisemgangathweni: 0.20 mL ye-0.020 N i-asidi ye-sulfuric
Isampulu: 3 g yeGlycine
Indlela yokwamkelwa: NMT 0.0065%
• IIMETALI EZINZIMA, Indlela I <231>: NMT 20 ppm
• IIMETALI EZINZIMA, Indlela I <231>: NMT 20 ppm
Isisombululo sesampuli: 100 mg / mL yeGlycine
Uhlalutyo: Bilisa i-10 mL yeSampule yesisombululo kwi-1 min, kwaye ubeke bucala i-2 h.
Iinqobo zokwamkelwa: Isisombululo sibonakala sicacile kwaye sihamba njenge-10 mL yesisombululo esifanayo esingazange sibiliswe.
IIMVAVANYO EZITHILE
• UKULAHLEKO EKOMISENI <731>: Yomisa isampuli kwi-105° kangange-2 h: ilahlekelwa yi-NMT nge-0.2% yobunzima bayo.
IIMFUNO EZONGEZELELWEYO
• UKUPAKIWA NOKUGCINWA: Londoloza kwizikhongozeli ezivalwe kakuhle.
• IMIGANGATHO YE-USP REFERENCE <11>
USP Glycine RS

Japanese Pharmacopoeia JP17
I-Glycine, xa yomisiwe, ayinayo ngaphantsi kwe-98.5% ye-Glycine (C2H5NO2).
Ingcaciso I-Glycine yenzeka imhlophe, iikristale okanye umgubo wecrystalline.Inencasa eswiti.Inyibilika ngokukhululekileyo emanzini nakwi-asidi ye-formic, kwaye ayinyibiliki kwi-ethanol (95).Ibonisa i-crystal polymorphism.
Ukuchonga Ukumisela i-spectrum ye-infrared yokufunxa ye-Glycine, eyomisiwe ngaphambili, njengoko iqondiswe kwindlela yedisk ye-potassiumbromide phantsi kwe-Infrared Spectrophotometry <2.25>, kwaye uthelekise i-spectrum kunye ne-Reference Spec-trum: zombini i-spectra ibonisa ubunzulu obufanayo bokufunxa kumanani amaza afanayo.Ukuba kukho umahluko obonakalayo phakathi kwe-spectra, nyibilikisa i-Glycine emanzini, ukhuphe ubushushu bamanzi, kwaye uphinda uvavanyo kunye nentsalela.
pH <2.54> Dissolve 1.0 g yeGlycine kwi-20 mL yamanzi: i-thepH yesisombululo iphakathi kwe-5.6 kunye ne-6.6.
Ubunyulu
(1) Ukucaca kunye nombala wesisombululo-Dibanisa i-1.0 gof Glycine kwi-10 mL yamanzi: isisombululo sicacile kwaye singenambala.
(2) I-Chloride <1.03>-Yenza uvavanyo nge-0.5 g yeGlycine.Lungisa isisombululo sokulawula nge-0.30 mL ye-0.01mol / L i-hydrochloric acid VS (kungekho ngaphezu kwe-0.021%)
(3) Sulfate <1.14>-Yenza uvavanyo kunye ne-0.6 g yeGlycine.Lungisa isisombululo sokulawula kunye ne-0.35 mL ye-0.005mol / L i-sulfuric acid VS (engekho ngaphezu kwe-0.028z).
(4) Ammonium <1.02>-Yenza uvavanyo usebenzisa i-0.25 g yeGlycine.Lungiselela isisombululo sokulawula kunye ne-5.0 mL ye-Standard Ammonium Solution (engekho ngaphezu kwe-0.02%).
(5) Iintsimbi ezinzima <1.07>-Qhubeka kunye ne-1.0 g yeGlycine ngokweNdlela ye-1, kwaye wenze uvavanyo.Lungiselela isisombululo sokulawula kunye ne-2.0 mL yeSisombululo esiPhambili seNkokheli (kungekho ngaphezu kwe-20 ppm).
(6) Arsenic <1.11> -Lungisa isisombululo sovavanyo kunye ne-1.0 gof Glycine ngokweNdlela ye-1, kwaye wenze uvavanyo (kungekho ngaphezu kwe-2 ppm).
(7) Izinto eziNxulumeneyo-Dissolve 0.10 g yeGlycine kwi-25mL yamanzi kwaye usebenzise esi sisombululo njengesisombululo sesampuli.Umbhobho oyi-1 mL yesisombululo sesampulu, yongeza amanzi ukwenza i-50mL ngqo.Umbhobho we-5 mL yesi sisombululo, yongeza amanzi ukwenza ngokuchanekileyo i-20 mL, kwaye usebenzise esi sisombululo njengesisombululo esiqhelekileyo.Yenza uvavanyo ngezi zisombululo njengoko kuqondiswe phantsi kwe-Thin-layer Chromatography<2.03>.Indawo ye-5mL nganye yesisombululo sesampulu kunye nesisombululo esisemgangathweni kwipleyiti ye-silica gel forthin-layer chromatography.Phuhlisa ipleyiti ngomxube we-1-butanol, amanzi kunye ne-acetic acid (100) (3: 1: 1) ukuya kumgama omalunga ne-10 cm, kwaye womise ipleyiti kwi-80 ℃ imizuzu engama-30.Gcoba ngokulinganayo isisombululo se-ninhydrin kwi-acetone (i-1 ku-50), kwaye ushushu kwi-80 ℃ imizuzu emi-5: amabala angaphandle kwebala eliphambili kwisisombululo sesampulu alinamandla ngaphezu kwendawo evela kwisisombululo esiqhelekileyo.
Ilahleko ekomileyo <2.41> Akukho ngaphezu kwe-0.30% (1 g, 105℃, iiyure ezi-3).
Intsalela kwi-Ignition <2.44> Akukho ngaphezu kwe-0.10% (1g).
I-Assay Ukulinganisa ngokuchanekileyo malunga ne-80 mg ye-Glycine, eyomisiwe ngaphambili, ichithe kwi-3 mL ye-acidic acid, yongeza i-50 mL ye-acetic acid (100), kunye ne-titrate <2.50> kunye ne-0.1 mol / L perchloric acid VS (i-potentiometric titration).Yenza isigqibo esingenanto, kwaye wenze naluphi na ulungiso oluyimfuneko.
I-mL nganye ye-0.1 mol/L ye-perchloric acid VS＝7.507 mg ye-C2H5NO2
Imigqomo kunye nokugcinwa Izikhongozeli-Izikhongozeli ezivalwe kakuhle.