Sub menu

 
 

Shea Butter Ethyl Esters

Compositional guideline for 'Shea Butter Ethyl Esters' permitted for use in listed medicines

Last updated

Name of the ingredient

Shea butter ethyl esters (AAN# 141530).

Definition of the ingredient

Shea butter ethyl esters is the purified reaction product manufactured through the trans-esterification of shea butter or shea oil with ethanol in the presence of an alkaline catalyst. The substance is composed of the ethyl esters of palmitic, stearic, oleic and linoleic acids, and unsaponifiable matter derived from the shea butter.

CAS Number(s): 1456887-14-1

Characteristics

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description

Appearance and colour

Visual

Pale yellow liquid

Odour

Organoleptic

Weak fruity odour

Slip melting point

AOCS Cc 3-25

10°C

Viscosity (20°C)

Höppler viscometer

15 mPas

Viscosity (40°C)

Höppler viscometer

11 mPas

Density (25°C)

Electronic density meter

870 g/L

Saponification value

IUPAC 2.202

175 mg KOH/g
Identification

Fatty acid profile

IUPAC 2.304 (Gas chromatography)1

Retention time for Ethyl oleate, Ethyl stearate, Ethyl palmitate, and Ethyl linoleate matches those of reference material(s).

FT-IR spectrum

FT-IR2

The obtained FT-IR spectrum should match that of the reference material with the observation of characteristic peaks at 2922, 2852, 1737, 1639, 1464, 1372, 1350-1180, 1176, 858, and 722 cm-1.
Assay

Ethyl oleate

IUPAC 2.304 (Gas Chromatography)1

40-70% (w/w)

Ethyl stearate

IUPAC 2.304 (Gas Chromatography)1

15-45% (w/w)

Ethyl palmitate

IUPAC 2.304 (Gas Chromatography)1

2-9% (w/w)

Ethyl linoleate

IUPAC 2.304 (Gas Chromatography)1

8-10% (w/w)

Unsaponifiable matter

AOCS Ca 6a-40

6-9%
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Residual Solvents

Hexane

HS-GC-FID3

<1 mg/Kg

Acetone

HS-GC-FID3

<1 mg/Kg

Methanol

HS-GC-FID3

<10 mg/Kg

Ethanol

HS-GC-FID3

<10 mg/Kg
Incidental metals and non-metals

Arsenic

DIN EN ISO 15763 (ICP-MS)

<0.1 mg/Kg

Cadmium

DIN EN ISO 15763 (ICP-MS)

<0.05 mg/Kg

Copper

DIN EN ISO 15763 (ICP-MS)

<0.05 mg/Kg

Lead

DIN EN ISO 15763 (ICP-MS)

<0.1 mg/Kg

Mercury

DIN EN ISO 15763 (ICP-MS)

<0.02 mg/Kg

Nickel

DIN EN ISO 15763 (ICP-MS)

<0.2 mg/Kg
Pesticide residues and environmental contaminants: (including agricultural and veterinary substances)

Endosulfan4

GC (SANCO/12571/2013)

<0.1 mg/Kg
Other organic or inorganic impurities or toxins

Benzo(a)pyrene (BaP)5

GC-MS

<2.0 µg/Kg

Iodine value Wijs

IUPAC 2.205

63-75

Lovibond colour 5 ¼” Red

AOCS Cc 13j-97

<2.0

Acid value

IUPAC 2.201

<1.0 mg KOH/Kg

Peroxide value

AOCS Cd 8b-90

<5.0 meq O2/Kg
Microbiology

Total plate count

ISO 4833-1

<100 cfu/g

Yeasts

ISO 21572-2

<10 cfu/g

Molds

ISO 21572-2

<10 cfu/g

Enterobacteriaceae

ISO 21528-1

<10 cfu/g

Salmonella

ISO 6579

Absent in 25 g
Notes
  1. GC: Column: Varian fused silica CP-Wax-52CB (10 m x 0.10 mm id, DF 0.2, cat no. CP7335) or equivalent column; Injection volume: 0.2 μL in Split ratio: 40; Post-injection delay: 0.01 min; Injection speed: 5 µL/s; Solvent plug: 1.0 µL; Nitrogen carrier gas: 60 psi; Injector temperature: 230°C; Column temperature: 110-250°C (50°C/min), 250-260°C (6°C/min; 1 min); Detector gas: make-up gas 25 mL/min, air 300 mL/min and hydrogen 30 mL/min; Detector temperature: 230°C; Range: 10-12 amps/mV.
  2. FT-IR spectrum collection parameters: Spectrum is obtained directly from sample at room temperature; Number of scans: 32; Resolution: 4; Spectrum format: transmittance; Spectral range: 4000-625 cm-1.
  3. HS-GC-FID: Sample (3 g) is incubated for 10 minutes at 100°C; 1 mL of sample from headspace is injected on an Agilent Poraplot Q fused silica column (10 m x 0.32 mm id, df 10 µm) or an equivalent column; Carrier gas: Helium or Nitrogen at constant pressure; Split flow: 30 mL/min; Detector gas: Hydrogen (30 mL/min), air (300 mL/min); Column temperature: 170°C; Injector temperature: 220°C; Detector temperature: 220°C.
  1. Endosulfan is used as an indicator substance to test for the in-process removal of pesticide residues.
  2. Benzo(a)pyrene (BaP) is used as an indicator substance to test for the in-process removal of polyaromatic hydrocarbons.

Key to abbreviations:

AOCS = American Oil Chemists’ Society

GC = Gas Chromatography

GC-MS = Gas Chromatography coupled with Mass Spectrometry

HPLC = High Performance Liquid Chromatography

HS-GC-FID = Headspace analysis using Gas Chromatography with Flame Ionisation Detector

ICP-MS = Inductively Coupled Plasma coupled with Mass Spectrometry

FT-IR = Fourier Transform - Infrared Spectroscopy

ISO = International Organisation for Standardisation

IUPAC = International Union of Pure and Applied Chemistry

LC-FLD = Liquid Chromatography with Fluorescence Detector

Ph Eur = European Pharmacopoeia

SANCO = European Commission – Safety of the food chain – Chemicals, contaminants, pesticides

USP = United States Pharmacopoeia

Topics

Help us improve the Therapeutic Goods Administration site