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

Saukewa: USP35-NF30
BAYANI
Glycine ya ƙunshi NLT 98.5% da NMT 101.5% na glycine (C2H5NO2), ƙididdiga akan busasshen tushe.
GANO
A. RASHIN NUTSUWA <197M>
ASSAY
• TSARI
Misali: 150 MG na glycine
Blank: 100 ml na glacial acetic acid
Titrimetric tsarin
(Duba Titrimetry <541>.)
Yanayin: Kai tsaye titration
Titrant: 0.1 N kowane chloric acid VS
Gano ƙarshen ƙarshen: Na gani
Analysis: Narkar da Samfurin a cikin 100 ml na glacial acetic acid, kuma ƙara 1 digo na crystal violet TS.Titrate tare da Titrant zuwa ƙarshen ƙarshen kore.Yi ƙudurin Blank.
Yi lissafin adadin glycine (C2H5NO2) a cikin Samfurin da aka ɗauka:
Sakamako = {[(VS - VB) × N × F]/W} × 100
VS = Girman titrant yana cinye ta Samfurin (mL)
VB = Girman titrant da Blank (mL) ke cinyewa
N = ainihin al'ada na Titrant (mEq/ml)
F = ma'auni daidai, 75.07 mg/mEq
W = Nauyin Nauyin (mg)
Sharuɗɗan karɓa: 98.5% -101.5% akan busasshen tushe
RASHIN ZUCIYA
• SAURAN WUTA <281>: NMT 0.1%
• chloride da sulfate, Chloride <221>
Daidaitaccen bayani: 0.10 ml na 0.020 N hydrochloric acid
Misali: 1 g na glycine
Sharuɗɗan karɓa: NMT 0.007%
• chloride da sulfate, sulfate <221>
Daidaitaccen bayani: 0.20 ml na 0.020 N sulfuric acid
Misali: 3 g na glycine
Sharuɗɗan karɓa: NMT 0.0065%
• KARFE MAI KYAU, Hanyar I <231>: NMT 20 ppm
• KARFE MAI KYAU, Hanyar I <231>: NMT 20 ppm
Samfurin bayani: 100 MG / ml na Glycine
Analysis: Tafasa 10 ml na Maganin Samfurin na minti 1, kuma a ajiye shi na awa 2.
Sharuɗɗan karɓa: Maganin ya bayyana a sarari kuma azaman wayar hannu kamar 10 ml na maganin iri ɗaya wanda ba a tafasa ba.
MAKAMMAN JARRABAWA
• RASHIN bushewa <731>: Busa samfurin a 105 ° na 2 h: yana rasa NMT 0.2% na nauyinsa.
KARIN BUKATA
KYAUTA DA ARJIYA: Ajiye a cikin kwantena masu kyau.
• MATSAYIN MAGANAR USP <11>
USP Glycine RS

Japan Pharmacopoeia JP17
Glycine, lokacin da aka bushe, ya ƙunshi ƙasa da 98.5% na Glycine (C2H5NO2).
Bayanin Glycine yana faruwa azaman fari, lu'ulu'u orcrystalline foda.Yana da ɗanɗano mai daɗi.Yana iya narkewa cikin ruwa kuma a cikin formic acid, kuma a zahiri baya narkewa a cikin ethanol (95).Yana nuna crystal polymorphism.
Identification Ƙayyade nau'in shayarwar infrared na Glycine, wanda aka bushe a baya, kamar yadda aka umarce shi a cikin hanyar faifan potassiumbromide a ƙarƙashin Infrared Spectrophotometry <2.25>, kuma kwatanta bakan tare da Spec-trum: duka bakan suna nuna irin ƙarfin sha a lambobi iri ɗaya.Idan wani bambanci ya bayyana tsakanin bakan, narkar da Glycine a cikin ruwa, kawar da bushewar ruwan, kuma maimaita gwajin tare da ragowar.
pH <2.54> Narke 1.0 g na Glycine a cikin 20 ml na ruwa: pH na maganin yana tsakanin 5.6 da 6.6.
Tsafta
(1) Tsabtace da launi na bayani-Narke 1.0 gof Glycine a cikin 10 ml na ruwa: bayani a bayyane yake kuma mara launi.
(2) Chloride <1.03>-Yi gwajin tare da 0.5 g na Glycine.Shirya maganin sarrafawa tare da 0.30 ml na 0.01mol/L hydrochloric acid VS (ba fiye da 0.021%)
(3) Sulfate <1.14> - Yi gwajin tare da 0.6 g na Glycine.Shirya maganin sarrafawa tare da 0.35 ml na 0.005mol/L sulfuric acid VS (bai wuce 0.028z ba).
(4) Ammonium <1.02> -Yi gwajin ta amfani da 0.25 g na Glycine.Shirya maganin sarrafawa tare da 5.0 ml na Standard Ammonium Solution (ba fiye da 0.02%) ba.
(5) Karfe masu nauyi <1.07> - Ci gaba da 1.0 g na Glycine bisa ga Hanyar 1, kuma yi gwajin.Shirya maganin sarrafawa tare da 2.0 ml na Maganin Gubar Daidaitawa (bai wuce 20 ppm ba).
(6) Arsenic <1.11> -Shirya maganin gwajin tare da 1.0 gof Glycine bisa ga Hanyar 1, kuma yi gwajin (ba fiye da 2 ppm ba).
(7) Abubuwan da ke da alaƙa-Narke 0.10 g na Glycine a cikin 25mL na ruwa kuma amfani da wannan maganin azaman maganin samfurin.Pipet 1 ml na maganin samfurin, ƙara ruwa don yin daidai 50 ml.Pipet 5 mL na wannan bayani, ƙara ruwa zuwa 20 mL daidai, kuma amfani da wannan bayani a matsayin daidaitaccen bayani. Yi gwajin tare da waɗannan mafita kamar yadda aka umarta a ƙarƙashin Thin-Layer Chromatography <2.03>.Spot 5mL kowane samfurin bayani da daidaitaccen bayani akan farantin silica gel forthin-Layer chromatography.Ci gaba da farantin tare da cakuda 1-butanol, ruwa da acetic acid (100) (3: 1: 1) zuwa nisa na kimanin 10 cm, kuma bushe farantin a 80 ℃ na minti 30.Fesa maganin ninhydrin a ko'ina a cikin acetone (1 a cikin 50), kuma zafi a 80 ℃ na minti 5: aibobi banda babban tabo daga maganin samfurin ba su da ƙarfi fiye da tabo daga daidaitaccen bayani.
Asara akan bushewa <2.41> Bai wuce 0.30% ba (1 g, 105 ℃, awanni 3).
Ragowa akan ƙonewa <2.44> Bai wuce 0.10% ba (1g).
Assay Yi nauyi daidai game da 80 MG na Glycine, wanda aka bushe a baya, narke a cikin 3 ml na formic acid, ƙara 50 ml na acetic acid (100), da titrate <2.50> tare da 0.1 mol/L perchloric acid VS (titration potentiometric).Yi wata manufa ta ƙasa, kuma kuyi kowane gyaran.
Kowane ml na 0.1 mol/L perchloric acid VS 7.507 MG na C2H5NO2
Kwantena da Ma'ajiyar Kwantena-Kyakkyawan rufaffiyar kwantena.