Glycine CAS 56-40-6 (H-Gly-OH) Nyocha 98.5 ~ 101.5% Ụlọ ọrụ dị elu

USP35-NF30
Nkọwa
Glycine nwere NLT 98.5% na NMT 101.5% nke glycine (C2H5NO2), gbakọọ na ntọala akpọnwụwo.
Nchọpụta
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ASSAY
• Usoro
Ihe atụ: 150 mg nke glycine
Oghere: 100 ml nke glacial acetic acid
Titrimetric usoro
(Lee Titrimetry <541>.)
Ụdị: Direct titration
Titrant: 0.1 N kwa chloric acid VS
Nchọpụta njedebe: Anya
Nyocha: Gbarie Sample na 100 ml nke glacial acetic acid, ma tinye 1 dobe nke crystal violet TS.Titrate na Titrant gaa na njedebe akwụkwọ ndụ akwụkwọ ndụ.Mee mkpebi nke oghere ahụ.
Gbakọọ pasent glycine (C2H5NO2) dị na nlele emere:
Nsonaazụ = {[(VS - VB) × N × F]/W} × 100
VS = Titrant olu nke Sample (mL) na-eri.
VB = Olu titrant na-eri site na oghere (mL)
N = ezigbo ọnọdụ nke Titrant (mEq/ml)
F = ihe nhata, 75.07 mg/mEq
W = Ihe atụ aro (mg)
Usoro nnabata: 98.5% -101.5% na ntọala akpọnwụwo
IHE adịghị ọcha
• AKWỤKWỌ NA MKWAGHỊ <281>: NMT 0.1%
• chloride na sulfate, Chloride <221>
Ihe ngwọta ọkọlọtọ: 0.10 ml nke 0.020 N hydrochloric acid
Ihe atụ: 1 g nke glycine
Usoro nnabata: NMT 0.007%
• chloride na sulfate, sulfate <221>
Ihe ngwọta ọkọlọtọ: 0.20 ml nke 0.020 N sulfuric acid
Ihe atụ: 3 g nke glycine
Usoro nnabata: NMT 0.0065%
• Ọla dị arọ, Usoro I <231>: NMT 20 ppm
• Ọla dị arọ, Usoro I <231>: NMT 20 ppm
Ngwọta nlele: 100 mg / ml nke glycine
Nyocha: sie 10 ml nke ihe ngwọta maka 1 min, ma debe maka awa 2.
Usoro nnabata: Ihe ngwọta na-apụta dị ka nke doro anya ma dị ka mkpanaka dị ka 10 ml nke otu ngwọta a na-esibeghị.
Nnwale akọwapụtara
• Ọnwụ na-ehichapụ <731>: Kpochapụ ihe nlele na 105 ° maka awa 2: ọ na-efunahụ NMT 0.2% nke ibu ya.
NKWUO GBASARA YA
• Nkwakọba na Nchekwa: Chekwaa n'ime akpa mechiri emechi nke ọma.
• Ụkpụrụ ntụaka USP <11>
USP Glycine RS

Japanese Pharmacopoeia JP17
Glycine, mgbe akpọnwụwo, nwere ihe na-erughị 98.5% nke Glycine (C2H5NO2).
Nkọwa Glycine pụtara dị ka ọcha, kristal orcrystalline ntụ ntụ.Ọ nwere ụtọ ụtọ.Ọ na-agbaze n'efu na mmiri yana na formic acid, yana ọ fọrọ nke nta ka ọ bụrụ ihe a na-apụghị imeri na ethanol (95).Ọ na-egosi kristal polymorphism.
Kpebie ụdị nnabata infrared nke Glycine, nke akpọnwụworị, dị ka eduzi ya na usoro potassiumbromide disk n'okpuru Infrared Spectrophotometry <2.25>, ma were ụdịdị dị iche iche na Reference Spec-trum: ụdịdị abụọ ahụ na-egosipụta ike nke absorption n'otu nọmba ebili mmiri.Ọ bụrụ na ọdịiche ọ bụla pụtara n'etiti spectra, gbazee Glycine n'ime mmiri, kpochapu mmiri ahụ, wee jiri ihe fọdụrụ megharịa ule ahụ.
pH <2.54> Gbari 1.0 g nke Glycine na 20 ml mmiri: pH nke ngwọta dị n'etiti 5.6 na 6.6.
Ịdị ọcha
(1) Ịdị ọcha na agba nke ngwọta-Gbasa 1.0 gof Glycine na 10 ml mmiri: ngwọta doro anya na-enweghị agba.
(2) Chloride <1.03>-Mee ule na 0.5 g nke Glycine.Kwadebe ngwọta nchịkwa na 0.30 ml nke 0.01mol / L hydrochloric acid VS (ọ bụghị karịa 0.021%).
(3) Sulfate <1.14>-Mee ule na 0.6 g nke Glycine.Kwadebe ngwọta nchịkwa na 0.35 ml nke 0.005mol/L sulfuric acid VS (ọ bụghị karịa 0.028z).
(4) Ammonium <1.02>-Mee ule ahụ site na iji 0.25 g nke Glycine.Kwadebe ngwọta nchịkwa na 5.0 ml nke Standard Ammonium Solution (ọ bụghị karịa 0.02%).
(5) Ọla dị arọ <1.07>-Gaa n'ihu na 1.0 g nke Glycine dịka usoro 1 si dị, ma mee ule ahụ.Kwadebe ngwọta njikwa na 2.0 ml nke Standard Lead Solution (ọ bụghị ihe karịrị 20 ppm).
(6) Arsenic <1.11> - Kwadebe ngwọta ule na 1.0 gof Glycine dị ka usoro 1 si dị, ma mee ule ahụ (ọ bụghị karịa 2 ppm).
(7) Ihe ndị metụtara ya - gbazee 0.10 g nke Glycine na 25mL mmiri wee jiri ngwọta a dị ka ihe nlele.Pipet 1 mL nke ngwọta nlele, gbakwunye mmiri iji mee kpọmkwem 50 ml.Pipet 5 mL nke ihe ngwọta a, tinye mmiri ka ọ bụrụ kpọmkwem 20 ml, ma jiri ngwọta a dị ka ihe ngwọta ọkọlọtọ. Mee ule na ngwọta ndị a dị ka ntụziaka n'okpuru Thin-layer Chromatography <2.03>.Kpatụ 5mL nke ọ bụla n'ime ihe nlere anya yana ngwọta ọkọlọtọ na efere silica gel forthin-layer chromatography.Mepụta efere ahụ na ngwakọta nke 1-butanol, mmiri na acetic acid (100) (3: 1: 1) ruo ihe dịka 10 cm, wee kpoo efere ahụ na 80 ℃ maka nkeji 30.Fesa ihe ngwọta nke ninhydrin n'otu n'otu na acetone (1 n'ime 50), wee kpoo ọkụ na 80 ℃ maka nkeji 5: ntụpọ ndị ọzọ na-abụghị isi ebe sitere na ngwọta nlele adịghị ike karịa ebe sitere na ngwọta ọkọlọtọ.
Ọnwụ na ihicha <2.41> Ọ bụghị ihe karịrị 0.30% (1 g, 105 ℃, awa 3).
Ihe fọdụrụ na mgbanye <2.44> Ọ bụghị karịa 0.10% (1g).
Assay tụrụ n'ụzọ ziri ezi banyere 80 mg nke Glycine, nke a mịrị amịburu, gbarie na 3 ml nke formic acid, tinye 50 ml acetic acid (100), na titrate <2.50> na 0.1 mol/L perchloric acid VS (potentiometric titration).Mee mkpebi siri ike, ma mee mgbazi ọ bụla dị mkpa.
Otu ml nke 0.1 mol/L perchloric acid VS 7.507 mg nke C2H5NO2
Akpa na ihe nchekwa ihe - akpa ndị mechiri emechi nke ọma.