PHR1060

Mesalamine

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 5-Aminosalicylic acid, 5-AS, 5-Amino-2-hydroxybenzoic acid, Mesalamine
• Linear Formula: H₂NC₆H₃-2-(OH)CO₂H
• CAS Number: 89-57-6
• Molecular Weight: 153.14
• Beilstein: 2090421
• EC Number: 201-919-1
• MDL number: MFCD00007877
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823090
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 1075; traceable to Ph. Eur. Y0000297; traceable to USP 1392705
• API family: mesalamine, mesalazine
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 275-280 °C (dec.) (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: Nc1ccc(O)c(c1)C(O)=O
• InChI: 1S/C7H7NO3/c8-4-1-2-6(9)5(3-4)7(10)11/h1-3,9H,8H2,(H,10,11)
• InChI key: KBOPZPXVLCULAV-UHFFFAOYSA-N
• Gene Information: human ... ALOX5(240) , PPARG(5468) , PTGS1(5742) , PTGS2(5743)

Description

General description

Mesalamine is a drug, which is structurally similar to salicylates. It exhibits anti-inflammatory activity and is widely used as a medication for the treatment of inflammatory bowel disease, including ulcerative proctitis and Crohn′s 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

Mesalamine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations using spectrophotometric technique.

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.

5-Aminosalicylic acid is a peroxidase substrate suitable for use in ELISA procedures. This substrate produces a soluble end product that is brown in color and can be read spectrophotometrically at 450 nm. The reaction may be stopped with 3 N NaOH and read at 550 nm.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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 LRAA7173 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H315,H317,H319,H335
• Precautionary Statements: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): No data available
• Flash Point(C): No data available