Printed on: Tue Aug 03 2021, 07:39:52 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-1B0EC0AB-C4CA-4FF6-AB18-C8711BE65241_2_en-US

(EST)
Printed by: Le Tran Official Date: Official as of 01-Dec-2015 Document Type: USP & DS @2021 USPC
1

F = equivalency factor, 455.7 mg/mmol

Zinc Gluconate W = Sample weight (mg)

Acceptance criteria: 97.0%–102.0% on the anhydrous

basis
IMPURITIES
• CHLORIDE AND SULFATE, Chloride á221ñ
Standard solution: 0.7 mL of 0.020 N hydrochloric acid
Sample: 1.0 g
Acceptance criteria: NMT 0.05%
C12H22O14Zn 455.67 • CHLORIDE AND SULFATE, Sulfate á221ñ
Bis(D-gluconato-O1,O2) zinc; Standard solution: 1.0 mL of 0.020 N sulfuric acid
Zinc D-gluconate (1:2) [4468-02-4]. Sample: 2.0 g
Acceptance criteria: NMT 0.05%
DEFINITION • ARSENIC, Method I á211ñ
Zinc Gluconate contains NLT 97.0% and NMT 102.0% of zinc Test preparation: 1 g in 35 mL of water
gluconate (C12H22O14Zn), calculated on the anhydrous basis. Acceptance criteria: NMT 3 ppm
• LIMIT OF LEAD
IDENTIFICATION [NOTE—For the preparation of all aqueous solutions and
• A. IDENTIFICATION TESTS—GENERAL, Zinc á191ñ: A 100-mg/ for the rinsing of glassware before use, use water that
mL solution meets the requirements. has been passed through a strong-acid, strong-base,
• B. THIN-LAYER CHROMATOGRAPHY mixed-bed ion-exchange resin. Select all reagents to

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Standard solution: 10 mg/mL of USP Potassium have as low a content of lead as practicable, and store
Gluconate RS all reagent solutions in containers of borosilicate
Sample solution: 10 mg/mL of Zinc Gluconate, heating in a glass. Cleanse glassware before use by soaking in
water bath at 60°, if necessary, to dissolve warm 8 N nitric acid for 30 min and by rinsing with
Chromatographic system deionized water.]
(See Chromatography á621ñ, Thin-Layer Chromatography.)
Mode: TLC
Adsorbent: 0.25-mm layer of chromatographic silica gel
Application volume: 5 µL
ci Ascorbic acid–sodium iodide solution: 100 mg/mL of
ascorbic acid and 192.5 mg/mL of sodium iodide
Trioctylphosphine oxide solution: 50 mg/mL of
trioctylphosphine oxide in 4-methyl-2-pentanone.
Developing solvent system: Alcohol, ethyl acetate, [CAUTION—This solution causes irritation. Avoid contact with
ammonium hydroxide, and water (50:10:10:30)
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eyes, skin, and clothing. Take special precautions in
Spray reagent: Dissolve 2.5 g of ammonium molybdate in disposing of unused portions of solutions to which this
50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, reagent is added.]
add 1.0 g of ceric sulfate, swirl to dissolve, and dilute with Standard solution: Transfer 5.0 mL of lead nitrate stock
2 N sulfuric acid to volume. solution TS, to a 100-mL volumetric flask, and dilute with
Analysis water to volume. Transfer 2.0 mL of the resulting solution
Samples: Standard solution and Sample solution
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to a 50-mL volumetric flask, and add 10 mL of 9 N

Develop the chromatogram until the solvent front has hydrochloric acid and 10 mL of water. Add 20 mL of
moved about three-fourths of the length of the plate. Ascorbic acid–sodium iodide solution and 5.0 mL of
Remove the plate from the chamber, and dry at 110° for Trioctylphosphine oxide solution. Shake for 30 s, and allow to
20 min. Allow to cool, and spray with the Spray reagent. separate. Add water to bring the organic solvent layer into
Heat the plate at 110° for about 10 min. the neck of the flask, shake again, and allow to separate.
Acceptance criteria: The principal spot of the Sample The organic layer is the Standard solution, and it contains 2
solution corresponds in color, size, and RF value to that of µg/mL of lead.
the Standard solution. Sample solution: To a 50-mL volumetric flask add 1.0 g of
ASSAY Zinc Gluconate, 10 mL of 9 N hydrochloric acid, 10 mL of
• PROCEDURE water, 20 mL of Ascorbic acid–sodium iodide solution, and
Sample: 700 mg of Zinc Gluconate 5.0 mL of Trioctylphosphine oxide solution. Shake for 30 s,
Blank: 100 mL of water and allow to separate. Add water to bring the organic
Titrimetric system solvent layer into the neck of the flask, shake again, and
(See Titrimetry á541ñ.) allow to separate. The organic layer is the Sample solution.
Mode: Direct titration Blank: To a 50-mL volumetric flask add 10 mL of 9 N
Titrant: 0.05 M edetate disodium VS hydrochloric acid, 10 mL of water, 20 mL of Ascorbic acid–
Endpoint detection: Visual sodium iodide solution, and 5.0 mL of Trioctylphosphine
Analysis: Dissolve the Sample in 100 mL of water. Add 5 mL oxide solution. Shake for 30 s, and allow to separate. Add
of ammonia–ammonium chloride buffer TS and 0.1 mL of water to bring the organic solvent layer into the neck of the
eriochrome black TS. Titrate with Titrant until the solution flask, shake again, and allow to separate. The organic layer
is deep blue in color. Perform a blank determination. is the Blank, and it contains 0 µg/mL of lead.
Calculate the percentage of zinc gluconate (C12H22O14Zn) Instrumental conditions
in the Sample taken: (See Atomic Absorption Spectroscopy á852ñ.)
Mode: Atomic absorption spectrophotometry
Result = {[(VS − VB) × M × F]/W} × 100 Analytical wavelength: 283.3 nm
Lamp: Lead hollow-cathode
VS = Titrant volume consumed by the Sample (mL) Flame: Air–acetylene
VB = Titrant volume consumed by the Blank (mL) System suitability
M = Titrant molarity (mmol/mL) Samples: Standard solution and Blank

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Printed on: Tue Aug 03 2021, 07:39:52 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-1B0EC0AB-C4CA-4FF6-AB18-C8711BE65241_2_en-US
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Printed by: Le Tran Official Date: Official as of 01-Dec-2015 Document Type: USP & DS @2021 USPC
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Suitability requirements: The absorbance of the Standard Result = (C × V)/W

solution and the absorbance of the Blank are significantly
different. C = concentration of cadmium in Sample solution A
Analysis (µg/mL), determined from the intercept of the
Samples: Standard solution, Sample solution, and Blank linear regression line
Concomitantly determine the absorbances of the Blank, V = volume of solvent taken to prepare Sample
Standard solution, and the Sample solution. Use the Blank solution A (mL)
to set the instrument to zero. W = weight of Zinc Gluconate taken to prepare Sample
Acceptance criteria: NMT 10 ppm: the absorbance of the solution A (g)
Sample solution does not exceed that of the Standard
solution. Acceptance criteria: NMT 5 ppm
• LIMIT OF CADMIUM • REDUCING SUBSTANCES
Standard stock solution: 0.1372 mg/mL of cadmium Sample: 1.0 g of Zinc Gluconate
nitrate Blank: 10 mL of water
Standard solution: Pipet 25 mL of the Standard stock Titrimetric system
solution into a 100-mL volumetric flask, add 1 mL of (See Titrimetry á541ñ.)
hydrochloric acid, dilute with water to volume, and mix. It Mode: Residual titration
contains 12.5 µg/mL of cadmium (Cd). Titrant 0.1 N iodine VS
Sample stock solution: Transfer 10.0 g of Zinc Gluconate Back titrant: 0.1 N sodium thiosulfate VS
into a 50-mL volumetric flask, and dissolve in and dilute Endpoint detection: Visual
with water to volume. Analysis: Transfer the Sample to a 250-mL conical flask,
Sample solution A: Transfer 5.0 mL of the Sample stock dissolve in 10 mL of water, and add 25 mL of alkaline cupric
citrate TS. Cover the flask, boil gently for 5 min, accurately

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solution to a 25-mL volumetric flask, and dilute with water
to volume. This solution contains 0 µg/mL of added timed, and cool rapidly to room temperature. Add 25 mL
cadmium from the Standard solution. of 0.6 N acetic acid, 10.0 mL of Titrant, and 10 mL of 3 N
Sample solution B: Transfer 5.0 mL of the Sample stock hydrochloric acid, and titrate with Back titrant, adding 3 mL
solution to a 25-mL volumetric flask, add 2.0 mL of the of starch TS as the endpoint is approached. Perform the
Standard solution, and dilute with water to volume. This blank determination.
solution contains 1.0 µg/mL of added cadmium from the
Standard solution.
Sample solution C: Transfer 5.0 mL of the Sample stock
ci Calculate the percentage of reducing substances (as
dextrose) in the Sample taken:

solution to a 25-mL volumetric flask, add 4.0 mL of the Result = {[(VB − VS) × N × F]/W} × 100
Standard solution, and dilute with water to volume. This
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solution contains 2.0 µg/mL of added cadmium from the VB = Back titrant volume consumed by the Blank
Standard solution. (mL)
Blank: Water VS = Back titrant volume consumed by the Sample
Instrumental conditions (mL)
(See Atomic Absorption Spectroscopy á852ñ.) N = Back titrant normality (mEq/mL)
Mode: Atomic absorption spectrophotometry F = equivalency factor, 27 mg/mEq
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Analytical wavelength: 228.8 nm W = Sample weight (mg)

Lamp: Cadmium hollow-cathode
Flame: Air–acetylene Acceptance criteria: NMT 1.0%
Analysis SPECIFIC TESTS
Samples: Sample solution A, Sample solution B, and Sample • PH á791ñ
solution C Sample solution: 10 mg/mL
Determine the absorbances. Correct the absorbance Acceptance criteria: 5.5–7.5
values of Sample solution A, Sample solution B, and Sample • WATER DETERMINATION, Method Ib á921ñ: NMT 11.6%
solution C from that of the Blank. Plot the corrected
absorbances of Sample solution A, Sample solution B, and ADDITIONAL REQUIREMENTS
Sample solution C versus their added cadmium • PACKAGING AND STORAGE: Preserve in well-closed
concentrations, in µg/mL. Draw the straight line best containers.
fitting the three points, and extrapolate the line until it • USP REFERENCE STANDARDS á11ñ
intercepts the concentration axis. From the intercept, USP Potassium Gluconate RS
determine the amount, in µg/mL, of cadmium in Sample
solution A.
Calculate the content of cadmium in the portion of Zinc
Gluconate taken:

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