Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p8
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 23290–26420

Abstracts Service (CAS) Registry Number.
oxidised polyethylene (CAS 68441-17-8) is the polymer produced by the mild air oxidation of polyethylene.
 (2) For oxidised polyethylene, the specifications are the following:
 (a) average molecular weight—min 1200 (osmometric);
 (b) viscosity at 125C—min 200cP;
 (c) oxygen content—max 9.1%;
 (d) acid value—max 70 mgKOH/g (ASTM D 1386);
 (e) drop point—min 95C (ASTM D 566);
 (f) density (20C)—0.93-1.05 g/cm3 (ASTM D 1298, D 1505);
 (g) extractable constituents:
 (i) in water—maximum 1.5%; and
 (ii) in 10% ethanol—max 2.3%; and
 (iii) in 3% acetic acid—max 1.8%; and
 (iv) in n-pentane—max 26.0%.
 Note  Extraction of oxidised polyethylene—25.0 g of finely ground oxidised polyethylene powder (particle size 300–1 000 μm) is extracted for 5 hours in the Soxhlet apparatus with 350 mL of solvent. The solvent is then distilled off and the distillation residue is dried in a vacuum oven at 80–90°C. After weighing the obtained residue, the components soluble in the solvent are calculated in % weight (based on the initial weight used).
S3—24 Specification for phytosterols, phytostanols and their esters
 (1) Subject to subsections (2) and (3), *phytosterols, phytostanols and their esters must comply with a monograph specification in section S3—2 or section S3—3.
 (2) However, for a mixture which contains no less than 950 g/kg of phytosterol and phytostanols, the concentration of hexane, isopropanol, ethanol, methanol or methyl ethyl ketone either singly or in combination must be no more than 2 g/kg.
 (3) The *total plant sterol equivalents content must contain no less than 95% des-methyl sterols.
S3—25 Specification for quaternary amine cellulose ion exchange resin
 (1) This specification relates to regenerated cellulose, cross-linked and alkylated with epichlorohydrin and propylene oxide, then derivatised with quaternary amine groups whereby the amount of epichlorohydrin plus propylene oxide is no more than 250% by weight of the starting amount of cellulose.
 (2) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH 2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.
S3—26 Specification for resistant maltodextrins
  For resistant maltodextrins, the specifications are the following:
 (a) chemical structure—glucopyranose linked by α(1-4), α(1-6), α/β(1-2), and α/β(1-3) glucosidic bonds; and contains levoglucosan;
 (b) dextrose equivalent—8-12;
 (c) appearance—free-flowing fine powder;
 (d) colour—white;
 (e) taste/odour—slightly sweet/odourless;
 (f) solution—clear;
 (g) pH (in 10% solution)—4-6;
 (h) moisture (%)—maximum 5;
 (i) ash (%)—maximum 0.2;
 (j) arsenic (ppm)—maximum 1;
 (k) heavy metals (ppm)—maximum 5;
 (l) microbiological:
 (i) *SPC (cfu/g)—maximum 300;
 (ii) yeast and mould (cfu/g)—maximum 100;
 (iii) Salmonella—negative to test;
 (iv) coliforms—negative to test.
S3—27 Specification for tall oil phytosterol esters
 (1) In this section:
tall oil phytosterol esters are phytosterols derived from tall oil pitch