English to Russian Medical Medical: Pharmaceuticals

Acceptance criteria:
NMT 5.0%

ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE:
Preserve in well-closed containers, store in a dry place, and avoid exposure to excessive heat.

USP REFERENCE STANDARDS
USP Neotame RS
USP Neotame Related Compound A RS
N-[3,3-Dimethylbutyl)-L-α-aspartyl]-L-phenylalanine.

Polysorbate 80

Portions of the monograph text that are national USP text, and are not part of the harmonized text, are marked with symbols to specify this fact.

Sorbitan, mono-9-octadecenoate, poly(oxy-1,2-ethanediyl)derivs., (Z)-;

Polyoxyethylene 20 sorbitan monooleate [9005-65-6].

DEFINITION
Polysorbate 80 is a mixture of partial esters of fatty acids, mainly oleic acid, with sorbitol and its anhydrides ethoxylated with approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides.

IDENTIFICATION
A. It meets the requirements of the test for Composition of Fatty Acids.
B. INFRARED ABSORPTION 197F

ASSAY

Change to read:

COMPOSITION OF FATTY ACIDS

Diluent:
20 g/L of sodium hydroxide in methanol

Boron trifluoride–methanol solution:
140 g/L of boron trifluoride in methanol