等级
certified reference material
pharmaceutical secondary standard
质量水平
Agency
traceable to Ph. Eur. G0600000
traceable to USP 1299007
API类
griseofulvin
CofA
current certificate can be downloaded
包装
pkg of 1 g
技术
HPLC: suitable
gas chromatography (GC): suitable
应用
pharmaceutical (small molecule)
包装形式
neat
储存温度
-10 to -25°C
SMILES字符串
ClC1=C(O[C@@]2(C(OC)=CC(C[C@H]2C)=O)C3=O)C3=C(OC)C=C1OC
InChI
1S/C17H17ClO6/c1-8-5-9(19)6-12(23-4)17(8)16(20)13-10(21-2)7-11(22-3)14(18)15(13)24-17/h6-8H,5H2,1-4H3/t8-,17+/m1/s1
InChI key
DDUHZTYCFQRHIY-RBHXEPJQSA-N
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一般描述
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
应用
Griseofulvin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
分析说明
These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.
其他说明
This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAA3652 in the slot below. This is an example certificate only and may not be the lot that you receive.
警示用语:
Danger
危险声明
危险分类
Carc. 2 - Repr. 1B - Skin Sens. 1
储存分类代码
6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
WGK
WGK 3
闪点(°F)
Not applicable
闪点(°C)
Not applicable
法规信息
涉药品监管产品
此项目有
High?perfrmance liquid chromatographic analysis of griseofulvin in drug substance and solid dosage forms: Separation of impurities and metabolites.
Townley E and Roden P
Journal of Pharmaceutical Sciences, 69(5), 523-526 (1980)
Oil-in-water microemulsion high performance liquid chromatographic analysis of pharmaceuticals.
Marsh A, et al.
Chromatographia, 59(9), 531-542 (2004)
Damir Elmar Zecevic et al.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 87(2), 264-270 (2014-04-29)
Many upcoming drug candidates are pH-dependent poorly soluble weak bases in the pH range of the gastrointestinal tract. This often leads to a high in vivo variability and bioavailability issues. Aiming to overcome these limitations, the design of solid dispersions
Mark Sacchetti
Journal of pharmaceutical sciences, 103(9), 2772-2783 (2013-12-12)
Pharmaceutical materials, crystalline and amorphous, sorb water from the atmosphere, which affects critical factors in the development of drugs, such as the selection of drug substance crystal form, compatibility with excipients, dosage form selection, packaging, and product shelf-life. It is
Dipy M Vasa et al.
Journal of pharmaceutical sciences, 103(9), 2911-2923 (2014-05-16)
Fifteen model drugs were quenched from 3:1 (w/w) mixtures with polyethylene glycol 4000 (PEG4000). The resulting solids were characterized using powder X-ray diffraction (PXRD), analysis of pair distribution function-transformed PXRD data (where appropriate), hot-stage polarized light microscopy, and differential scanning
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