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

USP35-NF30
DEFINITION
Glycine ine NLT 98.5% uye NMT 101.5% yeglycine (C2H5NO2), yakaverengerwa pane yakaomeswa.
KUZIVA
A. INFRARED ABSORPTION <197M>
ASSAY
• MAITIRO
Muenzaniso: 150 mg yeGlycine
Chisina chinhu: 100 mL yeglacial acetic acid
Titrimetric system
(Ona Titrimetry <541>.)
Mode: Direct titration
Titrant: 0.1 N per chloric acid VS
Kuonekwa kwekupedzisira: Kuona
Ongororo: Dissolve Sample mu100 mL yeglacial acetic acid, wowedzera 1 donhwe recrystal violet TS.Titrate neiyo Titrant kune yakasvibira yekupedzisira.Ita kusarudzika.
Verenga huwandu hwe glycine (C2H5NO2) muSample yakatorwa:
Zvabuda = {[(VS − VB) × N × F]/W} × 100
VS = Titrant vhoriyamu inopedzwa neSample (mL)
VB = Titrant vhoriyamu inopedzwa neiyo Blank (mL)
N = hunhu chaihwo hweTitrant (mEq/mL)
F = equivalency factor, 75.07 mg/mEq
W = uremu hwemuenzaniso (mg)
Maitiro ekugamuchira: 98.5% -101.5% pane yakaomeswa hwaro
KUSIRIRA
• ZVINOSARA PAKUBASA <281>: NMT 0.1%
• CHLORIDE NESULFATE, Chloride <221>
Mushonga wakakwana: 0.10 mL ye0.020 N hydrochloric acid
Muenzaniso: 1 g yeGlycine
Maitiro ekugamuchira: NMT 0.007%
• CHLORIDE NESULFATE, Sulfate <221>
Mushonga wakakwana: 0.20 mL ye0.020 N sulfuric acid
Muenzaniso: 3 g yeGlycine
Maitiro ekugamuchira: NMT 0.0065%
• METARI ZVIKURU, Nzira I <231>: NMT 20 ppm
• METARI ZVIKURU, Nzira I <231>: NMT 20 ppm
Sample solution: 100 mg/mL yeGlycine
Ongororo: Fashaidza 10 mL yeSample solution ye1 min, woisa parutivi kwe2h.
Maitiro ekugamuchira: Mhinduro inoratidzika seyakajeka uye senhare se10 mL yemushonga wakafanana usina kubikwa.
ZVIYEDZO ZVAKANAKA
• KURASUKA PAKUOMESA <731>: Pukuta sampuli pa105° kwe2 h: inorasikirwa neNMT 0.2% yehuremu hwayo.
ZVIMWE ZVINODIWA
• KUPAKA UYE KUCHENGETA: Chengetedza mumidziyo yakavharwa zvakanaka.
• USP REFERENCE ZVINHU <11>
USP Glycine RS

Japanese Pharmacopoeia JP17
Glycine, kana yaomeswa, ine isingasviki 98.5% yeGlycine(C2H5NO2).
Tsanangudzo Glycine inoitika sechena, makristasi kana crystalline poda.Rine kutapira.Inonyungudika zvakasununguka mumvura uye muformic acid, uye inenge isinganyunguriki mu ethanol (95).Inoratidza crystal polymorphism.
Chiziviso Sarudza iyo infrared absorption spectrum yeGlycine, yakamboomeswa, sekurairwa munzira ye potassiumbromide disk pasi peInfrared Spectrophotometry <2.25>, uye enzanisa iyo spectrum neReferensi Spec-trum: ese ma spectra anoratidza kusimba kwakafanana kwekunyura panhamba imwechete yemafungu.Kana paine mutsauko ukabuda pakati peiyo spectra, nyungudutsa Glycine mumvura, bvisa kuoma kwemvura, uye dzokorora bvunzo pamwe nezvasara.
pH <2.54> Dissolve 1.0 g yeGlycine mu20 mL yemvura: thepH yemushonga iri pakati pe5.6 ne6.6.
Kuchena
(1) Kujeka uye ruvara rwemhinduro-Dissolve 1.0 gof Glycine mu 10 mL yemvura: mhinduro yakajeka uye isina ruvara.
(2) Chloride <1.03>-Ita bvunzo ne0.5 g yeGlycine.Gadzirira mhinduro ine 0.30 mL ye0.01mol/L hydrochloric acid VS (kwete kupfuura 0.021%).
(3) Sulfate <1.14>-Ita muedzo ne 0.6 g yeGlycine.Gadzirira mhinduro yekudzora ne 0.35 mL ye0.005mol/L sulfuric acid VS (kwete kupfuura 0.028z).
(4) Ammonium <1.02>-Ita bvunzo uchishandisa 0.25 g yeGlycine.Gadzirira mhinduro yekutonga ne 5.0 mL yeStandard Ammonium Solution (kwete kupfuura 0.02%).
(5) Heavy Metals <1.07>-Enda ne 1.0 g yeGlycine maererano neMethod 1, uye ita muedzo.Gadzirira mhinduro yekutonga ne 2.0 mL yeStandard Lead Solution (kwete kupfuura 20 ppm).
(6) Arsenic <1.11>-Gadzirira mhinduro yekuedza ne 1.0 gof Glycine maererano neMethod 1, uye ita muedzo (kwete kupfuura 2 ppm).
(7) Zvine hukama-Dissolve 0.10 g yeGlycine mu 25mL yemvura uye shandisa iyi mhinduro semuenzaniso wekugadzirisa.Pipeti 1 mL yemhinduro yemuenzaniso, wedzera mvura kuita 50 mL chaiyo.Pipet 5 mL yemushonga uyu, wedzera mvura kuita 20 mL chaiyo, uye shandisa mhinduro iyi seyakajairwa mhinduro.Ita bvunzo nemhinduro idzi sekurairwa pasi peThin-layer Chromatography<2.03>.Spot 5mL imwe neimwe yemhinduro yemuenzaniso uye yakajairwa mhinduro pandiro yesilica gel forthin-layer chromatography.Gadzira ndiro nemusanganiswa we1-butanol, mvura uye acetic acid (100) (3: 1: 1) kune chinhambwe chingangoita masendimita gumi, woomesa ndiro pa80 ℃ kwemaminitsi makumi matatu.Mwaya zvakaenzana mhinduro yeninhydrin muacetone (1 mu50), uye kupisa pa80 ℃ kwemaminetsi mashanu: makwapa kunze kwenzvimbo huru kubva mumushonga wemhinduro haana kusimba kupfuura nzvimbo kubva kune yakajairwa mhinduro.
Kurasikirwa paKuomesa <2.41> Kwete kupfuura 0.30% (1 g, 105℃, maawa matatu).
Residue paIgnition <2.44> Kwete kupfuura 0.10% (1g).
Assay Weresa nemazvo nezve 80 mg yeGlycine, yakamboomeswa, nyungudika mu3 mL yeformic acid, wedzera 50 mL yeacetic acid (100), uye titrate <2.50> ine 0.1 mol/L perchloric acid VS (potentiometric titration).Ita blank determi-nation, uye ita chero gadziriso inodiwa.
Imwe mL ye0.1 mol/L perchloric acid VS＝7.507 mg yeC2H5NO2
Midziyo uye kuchengetera Containers-Zvakanaka-yakavharwa midziyo.