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Merck
CN

PHR1739

Supelco

美沙拉嗪杂质C

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

2-氨基苯酚

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线性分子式:
H2NC6H4OH
化学文摘社编号:
分子量:
109.13
Beilstein:
606075
EC 号:
MDL编号:
UNSPSC代码:
41116107
PubChem化学物质编号:
NACRES:
NA.24
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等级

certified reference material
pharmaceutical secondary standard

质量水平

Agency

traceable to Ph. Eur. Y0001569

API类

mesalazine, mesalamine

CofA

current certificate can be downloaded

包装

pkg of 200 mg

技术

HPLC: suitable
gas chromatography (GC): suitable

mp

170-175 °C (lit.)

应用

pharmaceutical (small molecule)

包装形式

neat

储存温度

2-30°C

SMILES字符串

Nc1ccccc1O

InChI

1S/C6H7NO/c7-5-3-1-2-4-6(5)8/h1-4,8H,7H2

InChI key

CDAWCLOXVUBKRW-UHFFFAOYSA-N

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一般描述

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.

应用

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.

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 LRAA7943 in the slot below. This is an example certificate only and may not be the lot that you receive.

象形图

Health hazardExclamation mark

警示用语:

Warning

危险声明

危险分类

Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Muta. 2

储存分类代码

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 2

闪点(°F)

334.4 °F - closed cup

闪点(°C)

168 °C - closed cup

法规信息

危险化学品
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分析证书(COA)

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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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