사양
- 순도: 함량 99.5%(건조물 기준); EP/BP/CP 적합
- IUPAC Name: 1-(3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrol-2-yl)-3-(4-methylphenyl)sulfonylurea
- EC Number: 244-260-5
- Molecular Weight: 323.4
- Chemical Formula: C15H21N3O3S
- CAS Number: 21187-98-4
- 제형 유형: 백색 분말
- 인증 기준: ChP/USP/BP/EP 규격 준수
- 규제 승인 상태: 의약품 등급
- Characteristics: A white powder
- Solubility: Practically insoluble in water: freely soluble in methylene chloride; Sparingly soluble in acetone(96%); slightly soluble in alcohol (96%)
- Identification: Conform to the spectrum of the CRS Gliclazide
- Heavy Metals: <10ppm
- Impurity B: 0.3ppm
- Related substances: <0.10%
- Loss on Drying: 0.1%
- Sulphated Ash: 0.01%
- Residual Solvents: Below LOQ
- assay (on dried basis): 99.5%
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