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Sorbitan Distearate

Compositional guideline Sorbitan Distearate permitted for use in listed medicines.

Description

Sorbitan distearate is the product of chemical esterification between stearic acid and sorbitol in the presence of a catalyst. The reaction mixture is then cooled, filtered, and sieved to yield the desired ingredient.

CAS No: 36521-89-8 

Molecular weight: 697.1 g/mol 

Molecular formula: C42H80O7

Test

Method reference

Acceptance criteria

CHARACTERISATION
General properties
AppearanceVisualWhite to Light Yellow Granules
Solubility USP <1236>0.676 ng/L
Residue on ignitionUSP <281>≤1.0%
Saponification valueUSP <401>160-166 mg KOH/g
Acid valueUSP <401>≤10.0 mg KOH/g
Identity
FT-IRUSP <1854>Observation of characteristic peaks at 2850, 1740, and 1170 cm-1.
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.

Abbreviations

  • CAS = Chemical Abstract Services
  • FT-IR = Fourier transform infrared spectroscopy
  • IUPAC = International Union of Pure and Applied Chemistry
  • USP = United States Pharmacopeia 
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