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Stearoyl Glutamic Acid

Compositional Guideline: Stearoyl Glutamic Acid permitted for use in listed medicines.

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Description

N-Stearoyl-L-glutamic acid is the product of the chemical reaction between L-glutamic acid and stearic acid. The reaction mixture is then neutralised and air dried to yield the desired ingredient. 

CAS Number:  3397-16-8

Molecular weight: 413.6 g/mol

Molecular formula: C23H43NO5 

Molecular structure:

Stearoyl Glutamic Acid

Test

Method reference

Acceptance criteria

CHARACTERISATION
General properties
AppearanceVisualWhite to pale yellow powder
Particle SizeUSP <786>400 – 1600 µm
Melting PointUSP <741>154.75 °C
SolubilityUSP <1236>1110.2 mg/L
Loss on DryingUSP <731>≤5.0%
Acid valueUSP <401>245 – 290 mg KOH/g
Nitrogen contentUSP <461>3.1-3.4%
Identity
FT-IRUSP <1854>Observation of characteristic peaks at 3330, 2920, 1730, 1645, and 1545 cm-1.
Gas ChromatographyGC[1]The retention time of the main component corresponds to the retention time of the standard solution.
Elemental impurities
Total Heavy MetalsUSP <233>≤20 ppm
LeadUSP <233>≤5 ppm
ArsenicUSP <233>≤3 ppm
MercuryUSP <233>≤3 ppm
CadmiumUSP <233>≤2 ppm
Microbiology
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 100 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 11 of the Order.

Footnotes

  1. GC: Fused silica capillary column of 0.2 to 0.3 mm i.d. and 25 to 30 m length with 5% phenylmethylsiloxane of 0.2 to 0.4 μm thickness cross-linked to the inner surface; Column temperature: 10°C per minute from 60°C to 280°C; Carrier gas: Helium; Flow rate: 1.0 mL per minute; Split ratio: Splitless; Inlet temperature: 150°C; Detector: Hydrogen flame ionisation detector; Detecting gas: Hydrogen (combustion gas) and air (support gas); Detector temperature: 300°C.

Abbreviations

  • CAS = Chemical Abstract Services
  • FT-IR = Fourier transform infrared spectroscopy
  • GC = Gas chromatography
  • USP = United States Pharmacopeia 
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