PHR1739

Mesalazine Impurity C

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 2-Aminophenol
• Linear Formula: H₂NC₆H₄OH
• CAS Number: 95-55-6
• Molecular Weight: 109.13
• Beilstein: 606075
• EC Number: 202-431-1
• MDL number: MFCD00007690
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823584
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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
• SMILES string: Nc1ccccc1O
• InChI: 1S/C6H7NO/c7-5-3-1-2-4-6(5)8/h1-4,8H,7H2
• InChI key: CDAWCLOXVUBKRW-UHFFFAOYSA-N

Description

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.

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.

Analysis Note

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

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.

Footnote

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.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Warning
• Hazard Statements: H302 + H332,H341
• Precautionary Statements: P202 - P261 - P264 - P301 + P312 - P304 + P340 + P312 - P308 + P313
• Hazard Classifications: Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Muta. 2
• Storage Class Code: 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