NF Monographs: Sorbitan Sesquioleate


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Sorbitan Sesquioleate

» Sorbitan Sesquioleate is a partial oleate ester of Sorbitol and its mono- and dianhydrides. It yields, upon saponification, not less than 74.0 percent and not more than 80.0 percent of fatty acids, and not less than 22.0 percent and not more than 28.0 percent of polyols (w/w).

Packaging and storage— Preserve in tight containers.

USP Reference standards

— USP Isosorbide RS. USP 1,4-Sorbitan RS.

Identification— It responds to Identification tests A and B under Sorbitan Monooleate.

: not more than 14.

: between 182 and 220.

: between 65 and 75.

Saponification value

: between 143 and 165.

Water, Method I

: not more than 1.0%.

Residue on ignition

: not more than 1.4%.

Heavy metals, Method II

: 0.001%.

Residual solvents

: meets the requirements.

(Official January 1, 2007)

Assay for fatty acids— Proceed as directed for Assay for fatty acids under Sorbitan Monooleate.

Assay for polyols— Proceed as directed for Assay for polyols under Sorbitan Monooleate.

Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3431

Pharmacopeial Forum : Volume No. 28(6) Page 1733

Phone Number : 1-301-816-8262