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Printed by: USP NF Official Date: Official as of 01-Jun-2023 Document Type: USP & NF @2024 USPC
Do Not Distribute DOI Ref: 5q8l9 DOI: https://doi.org/10.31003/USPNF_M89810_02_01
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Filter while hot, cool the filtrate, and dilute with water to
Zinc Stearate 50 mL. Transfer a 20-mL aliquot to the arsine generator
Octadecanoic acid, zinc salt; flask, and dilute with water to 35 mL.
Zinc stearate CAS RN®: 557-05-1. Acceptance criteria: NMT 1.5 ppm
DEFINITION Change to read:
Zinc Stearate is a compound of zinc with a mixture of solid
organic acids obtained from fats, and consists chiefly of • ▲LEAD á251ñ, Procedures, Procedure 1▲ (CN 1-Jun-2023)
variable proportions of zinc stearate and zinc palmitate. It Standard solution: To 20 mL of 0.2 N nitric acid add 5 µg
contains the equivalent of NLT 12.5% and NMT 14.0% of lead, 4 mL of Ammonia–Cyanide Solution, and 2 drops of
of ZnO. Hydroxylamine Hydrochloride Solution, and shake with
10.0 mL of Standard Dithizone Solution for 30 s. Pass
IDENTIFICATION through an acid-washed filter paper into a
• A. IDENTIFICATION TESTS—GENERAL, Zinc á191ñ color-comparison tube.
Sample solution: Mix 25 g with 200 mL of hot water, add Test preparation: Ignite 0.50 g in a platinum crucible for
60 mL of 2 N sulfuric acid, and boil until the fatty acids 15–20 min in a muffle furnace at 475°–500°. Cool, add 3
separate as a transparent layer. Cool the mixture, and drops of nitric acid, evaporate over a low flame to dryness,
remove the solidified layer of fatty acids. and ignite again at 475°–500° for 30 min. Dissolve the
Acceptance criteria: A portion of the water layer meets the residue in 1 mL of 8 N nitric acid, add 3 mL of Ammonium
requirements. Citrate Solution and 0.5 mL of Hydroxylamine Hydrochloride
• B. CONGEALING TEMPERATURE á651ñ Solution, and render alkaline to phenol red TS with
Analysis: Place the separated fatty acids obtained in ammonium hydroxide. Add 10 mL of Potassium Cyanide
Identification test A in a filter wetted with water, and wash Solution. Immediately extract the solution with successive
al
with boiling water until free from sulfate. Collect the fatty 5-mL portions of Dithizone Extraction Solution, draining off
acids in a small beaker, allow to cool, pour off the separated each extract into another separator, until the last portion of
water, then melt the acids. Filter into a dry beaker while hot, dithizone solution retains its green color. Shake the
and dry at 105° for 20 min. combined extracts for 30 s with 20 mL of 0.2 N nitric acid,
Acceptance criteria: The fatty acids congeal at a ci and discard the chloroform layer. Add to the acid solution
temperature not below 54°. 4.0 mL of Ammonia–Cyanide Solution and 2 drops of
ASSAY Hydroxylamine Hydrochloride Solution. Add 10.0 mL of
• PROCEDURE Standard Dithizone Solution, and shake the mixture for 30 s.
Sample solution: Boil 1 g of Zinc Stearate with 50 mL of Pass the chloroform layer through an acid-washed filter
0.1 N sulfuric acid for at least 10 min, or until the fatty acids paper into a color-comparison tube.
ffi
layer is clear, adding more water as necessary to maintain Acceptance criteria: The color of the Test preparation does
the original volume. Cool, and filter. Wash the filter and the not exceed that of the Standard solution (NMT 10 ppm).
flask thoroughly with water until the last washing is not acid • ALKALIES AND ALKALINE EARTHS
to litmus paper. Sample solution: Mix 2.0 g with 50 mL of water, and add
Analysis: Add to the combined filtrate and washings 15 mL 10 mL of hydrochloric acid. Boil until the solution is clear,
of ammonia–ammonium chloride buffer TS and 0.2 mL of filter while hot, and wash the separated fatty acids with
O
eriochrome black TS. Heat the solution to about 40°, and about 50 mL of hot water. Render the combined filtrate and
titrate with 0.05 M edetate disodium VS until the solution washings alkaline with 6 N ammonium hydroxide. Add
is deep blue in color. Each mL of 0.05 M edetate disodium ammonium sulfide TS to precipitate the zinc completely,
is equivalent to 4.069 mg of ZnO. dilute with water to 200 mL, mix, and filter.
Acceptance criteria: 12.5%–14.0% of ZnO Analysis: To 100 mL of the clear filtrate add 0.5 mL of
sulfuric acid, evaporate to dryness, and ignite to constant
IMPURITIES weight.
Acceptance criteria: The weight of the residue does not
Change to read: exceed 10 mg (1.0%).
• ▲ARSENIC á211ñ, Procedures, Procedure 1▲ (CN 1-Jun-2023) ADDITIONAL REQUIREMENTS
Test preparation: Mix 5.0 g with 50 mL of water. Cautiously • PACKAGING AND STORAGE: Preserve in well-closed
add 5 mL of sulfuric acid, and boil gently until the fatty acids containers.
layer is clear and the volume is reduced to about 25 mL.
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