PHR1247

Indomethacin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): IDM, 1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-3-indoleacetic acid
• Empirical Formula (Hill Notation): C₁₉H₁₆ClNO₄
• CAS Number: 53-86-1
• Molecular Weight: 357.79
• Beilstein: 497341
• EC Number: 200-186-5
• MDL number: MFCD00057095
• PubChem Substance ID: 329823251
• NACRES: NA.24

Properties

• Quality Level: 300
• grade: certified reference material; pharmaceutical secondary standard
• Agency: traceable to Ph. Eur. I0200000; traceable to USP 1341001
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: COc1ccc2n(c(C)c(CC(O)=O)c2c1)C(=O)c3ccc(Cl)cc3
• InChI: 1S/C19H16ClNO4/c1-11-15(10-18(22)23)16-9-14(25-2)7-8-17(16)21(11)19(24)12-3-5-13(20)6-4-12/h3-9H,10H2,1-2H3,(H,22,23)
• Inchi Key: CGIGDMFJXJATDK-UHFFFAOYSA-N
• Gene Information: human ... PTGS1(5742) , PTGS2(5743)

Description

General description

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.
Indomethacin drug is extensively employed as a pharmacologic agent to bring about the closure of patent ductus arteriosus (PDA) in premature infants.

Application

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.

Indomethacin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples by chromatography techniques.

Biochem/physiol Actions

Cyclooxygenase (COX) inhibitor that is relatively selective for COX-1.

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 LRAC0281 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS06
• Signal Word: Danger
• Hazard Statements: H300
• Precautionary Statements: P264 - P301 + P310
• Hazard Classifications: Acute Tox. 1 Oral
• Storage Class Code: 6.1B - Non-combustible, acute toxic Cat. 1 and 2 / very toxic hazardous materials
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable