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Key Documents

PHR1739

Supelco

Mesalazine Impurity C

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

2-Aminophenol

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About This Item

Fórmula linear:
H2NC6H4OH
Número CAS:
Peso molecular:
109.13
Beilstein:
606075
Número CE:
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to Ph. Eur. Y0001569

família API

mesalazine, mesalamine

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 200 mg

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

pf

170-175 °C (lit.)

aplicação(ões)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

2-30°C

cadeia de caracteres SMILES

Nc1ccccc1O

InChI

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

chave InChI

CDAWCLOXVUBKRW-UHFFFAOYSA-N

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Descrição geral

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.

Aplicação

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.

Nota de análise

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Outras notas

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.

Nota de rodapé

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.

Pictogramas

Health hazardExclamation mark

Palavra indicadora

Warning

Frases de perigo

Classificações de perigo

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

Código de classe de armazenamento

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

Classe de risco de água (WGK)

WGK 2

Ponto de fulgor (°F)

334.4 °F - closed cup

Ponto de fulgor (°C)

168 °C - closed cup


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Supelco

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Mesalazine European Pharmacopoeia (EP) Reference Standard

Y0000297

Mesalazine

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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