产品名称
美沙拉嗪杂质C, Pharmaceutical Secondary Standard; Certified Reference Material
SMILES string
Nc1ccccc1O
InChI
1S/C6H7NO/c7-5-3-1-2-4-6(5)8/h1-4,8H,7H2
InChI key
CDAWCLOXVUBKRW-UHFFFAOYSA-N
grade
certified reference material
pharmaceutical secondary standard
agency
traceable to Ph. Eur. Y0001569
API family
mesalazine, mesalamine
CofA
current certificate can be downloaded
packaging
pkg of 200 mg
technique(s)
HPLC: suitable
gas chromatography (GC): suitable
mp
170-175 °C (lit.)
application(s)
pharmaceutical (small molecule)
format
neat
storage temp.
2-30°C
Quality Level
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Analysis Note
These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.
Application
Mesalazine Impurity C may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.
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.
General description
Mesalazine Impurity C is a related compound of anti-inflammatory agent mesalazine. Mesalazine belongs to a group of drugs referred as aminosalicylates and is generally used in the treatment of inflammatory bowel disease.
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.
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.
Other Notes
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 LRAA7943 in the slot below. This is an example certificate only and may not be the lot that you receive.
signalword
Warning
hcodes
Hazard Classifications
Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Muta. 2
存储类别
6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
wgk
WGK 2
flash_point_f
334.4 °F - closed cup
flash_point_c
168 °C - closed cup
法规信息
危险化学品
此项目有
Mesalazine
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 6962-2066 (2019)
Determination of related substances in mesalazine by HPLC-electrochemical detection
Song DM and Yang YJ
Chinese Journal of Pharmaceuticals / Chung-kuo i yao kung yeh tsa chih, 38(6), 442-442 (2007)
Determination of Mesalamine related impurities from drug product by reversed phase validated UPLC method
Kanubhai TR, et al.
Journal of Chemistry, 8(1), 131-148 (2011)
Aminosalicylates in inflammatory bowel disease
Hanauer SB
Alimentary Pharmacology & Therapeutics, 20, 60-65 (2004)
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