Name of the ingredient
Beeswax alcohols (AAN#106965)
Definition of the ingredient
Beeswax alcohols is the powdered crystalline extract obtained from the beeswax by a saponification/extraction process. The material consists primarily of a mixture of six high molecular weight straight-chain alcohols which shows the following composition.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | ISO 6658 | Off white to cream powder |
| Odour | ISO 6658 | Neutral |
| Characteristics | ||
| Melting point | USP 40 (741) | 78 - 85°C |
| Loss on drying | USP 40 (731) | ≤1% |
| Solubility | USP 40 (1236) |
Insoluble in methanol & ethanol Slightly soluble in chloroform and 1,2-dichlorethane |
| Identification* | ||
| 1-tetracosanol (C24) | GC-FID[1] or GC-MS[2] | 6-15% |
| 1-hexacosanol (C¬26) | GC-FID[1] or GC-MS[2] | 7-20% |
| 1-octacosanol (C28) | GC-FID[1] or GC-MS[2] | 12-20% |
| 1-triacontanol (C30) | GC-FID[1] or GC-MS[2] | 25-35% |
| 1-dotriacontanol (C32) | GC-FID[1] or GC-MS[2] | 18-25% |
| 1-tetratriacontanol (C34) | GC-FID[1] or GC-MS[2] | ≤7.5% |
| Assay | ||
| Purity (total content of six high molecular weight alcohols)** | GC-FID[1] or GC-MS[2] | ≥85% |
| Notes | ||
|
*Identity expressed as the relative proportion of each alcohol in the raw material (% w/w), identified through the relative retentions (ri,s) of their trimethylsilyl (TMS) derivatives to that of 1-eicosanol (internal standard) **Purity is the sum of the total content of these alcohols, also reported in % (w/w) |
||
| Residual Solvents | ||
| Acetone | USP 40 (467) | ≤0.5% |
| Hexane | USP 40 (467) | ≤290 ppm |
| Incidental metals and non-metals | ||
| Heavy metals (Hg, Pb, Cd) | USP 40 (2232) or Atomic absorption [3] | ≤0.001% |
| Sodium (Na+) | USP 40 (2232) or Atomic absorption [3] | ≤0.02% |
| Potassium (K+) | USP 40 (2232) or Atomic absorption [3] | ≤0.7% |
| Microbiology | ||
| Total aerobic microbial count (TAMC) | USP 40 (61) (62) | ≤104 per g |
| Yeast and mould | USP 40 (61) (62) | ≤102 per g |
| Enterobacteria | USP 40 (61) (62) | ≤102 per g |
| Escherichia coli | USP 40 (61) (62) | Absent in 1 g |
| Staphylococcus aureus | USP 40 (61) (62) | Absent in 1 g |
| Salmonella sp | USP 40 (61) (62) | Absent in 10 g |
| Pseudomonas aeruginosa | USP 40 (61) (62) | Absent in 1 g |
| Candida albicans | USP 40 (61) (62) | Absent in 1 g |
Footnotes
| [1] | GC-FID: Column: HP5 capillary column (30 m x 0.25 mm id and 0.25 μm film thickness; Agilent, USA) – other equivalent columns like BPX-5, ZB-5, and DB-5 can be also used; Injection volume: 0.5 μL in splitless mode; Hydrogen carrier gas: 37 cm/sec (1 mL/min); For flame formation, hydrogen flux: 40 ml/min and air flux: 400 mL/min; Column temperature: 70°C (1 min), 70-200°C (30°C/min), 200-320°C (8°C/min), 320°C (15 min); Detector temperature: 320°C; Injector temperature: 320°C. |
|---|---|
| [2] | GC-MS: Column: HP5-MS capillary column (30 m x 0.25 mm id and 0.25 μm film thickness; Agilent, USA); Injection volume: 0.5 μL in splitless mode; Hydrogen carrier gas: 37 cm/sec (1 mL/min); Column temperature: 70°C (1 min), 70-200°C (30°C/min) 200-320°C (8°C/min), 320°C (15 min); Injector temperature: 320°C; Separator temperature: 280°C; Ion source temperature: 250°C; MS quadrupole temperature: 150°C; Electron energy: 70 eV, spectra is acquired from 40 to 800 m/z. |
| [3] | AA: For Cd and Pb contents, samples are digested in concentrated nitric acid, solids are digested in an acid mixture of nitric, sulphuric and perchloric acids, and heated up to 250 - 300C until the solution becomes transparent and wet salt crystals are formed. This solution is then diluted with deionised water. For Hg content, samples are transferred into a Teflon vase of the Paar digestion pump and digested with nitric acid. The Teflon vase is placed into the digestion pump, and the sealed system is then placed into a 90C oven. The content of the Teflon vase is transferred to a volumetric flask and diluted with deionised water.
After samples digestion, the content of Cd and Pb are directly assessed in an open system Atomic Absorption Spectrometer with a stochiometric air and acetylene flame. While for Hg content, it is assessed in a closed system using the cold steam technique coupled to the spectrometer without a flame. For both cases, triplicate samples are prepared, and blanks containing just concentrated nitric acid are subjected to the same digestion procedure and are ran in parallel. The content of Na+ and K+ ions is determined in digested samples and assessed in open system using an Atomic Absorption spectrometer with a stochiometric air and acetylene flame. |
Key to abbreviations
AA = Atomic Absorption
FID = Flame ionisation detector
GC = Gas Chromatography
MS = Mass spectrometry
ISO = International organisation for standardisation
USP = United States Pharmacopoeia