PHR1767

Melatonin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Melatonin, N-Acetyl-5-methoxytryptamine
• Empirical Formula (Hill Notation): C₁₃H₁₆N₂O₂
• CAS Number: 73-31-4
• Molecular Weight: 232.28
• Beilstein: 205542
• EC Number: 200-797-7
• MDL number: MFCD00005655
• PubChem Substance ID: 329823599
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 1077; traceable to USP 1380105
• API family: melatonin
• form: solid
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 116.5-118 °C (lit.)
• application(s): pharmaceutical (small molecule)
• storage temp.: 2-8°C
• SMILES string: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
• InChI: 1S/C13H16N2O2/c1-9(16)14-6-5-10-8-15-13-4-3-11(17-2)7-12(10)13/h3-4,7-8,15H,5-6H2,1-2H3,(H,14,16)
• InChI key: DRLFMBDRBRZALE-UHFFFAOYSA-N

Description

General description

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. It is analyzed using GMP validated instruments as per pharmacopeia monograph methods and is traceable to Unites States Pharmacopeia (USP), European Pharmacopeia (EP), and British Pharmacopeia (BP) primary standards, wherever applicable. It is provided with a comprehensive certificate of analysis (CoA) containing a certified purity value, calculated by the mass balance approach.
All information regarding the use of this CRM can be found on the certificate of analysis.

Melatonin is a methoxyindole compound secreted by the pineal gland in the mammalian brain. It regulates the sleep-wake cycles (circadian rhythm) and also has anti-inflammatory and antioxidant properties.

Application

Melatonin pharmaceutical reference standard may also be used as follows:

• Development and validation of a high-performance liquid chromatography (HPLC) method combined with UV detection to determine melatonin in capsule dosage forms
• Determination of melatonin in dog plasma samples by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method
• Simultaneous electrochemical analysis of melatonin and 5-hydroxytryptophan by poly-(melamine)/poly-(o-aminophenol) modified screen printed electrodes (SPCs) in human urine samples
• Determination of melatonin in pharmaceutical formulations by voltammetric and amperometric methods using carbon black modified glassy carbon electrode
• Electroanalytical determination of melatonin in tablet and human urine samples using a boron-doped diamond electrode and square-wave voltammetry (SWV)
• Development of nanopalladium polymeric nanocomposite modified glassy carbon electrode (GCE) for qualitative and quantitative analyses of melatonin in tablets and human urine samples by square-wave voltammetry
• Liquid chromatography-diode array detection (LC-DAD) of melatonin dose in supplements and also detection of impurities present in supplements by ultra-high-performance liquid chromatography-orbitrap mass spectrometry (UHPLC-orbitrap-MS)

Other Notes

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

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA8251 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable