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hydrochloric acid and dried by warming,

Sodium Borate (ホウ砂) exhibits a red color, which changes to blue


with ammonia TS added dropwise.
Na2B4O7.10H2O: 381.37
Sodium Borate contains not less than pH <2.54> Dissolve 1.0 g of Sodium Borate in
99.0% and not more than 103.0% of sodium 20 mL of water: the pH of this solution is
borate (Na2B4O7 • 10H2O). between 9.1 and 9.6.
Description Sodium Borate occurs as colorless
or white crystals or a white crystalline Purity (1) Clarity and color of
powder. It is odorless, and has a slightly solution—Dissolve 1.0 g of Sodium Borate in
characteristic, saline taste. 20 mL of water by warming slightly: the
It is freely soluble in glycerin, soluble in solution is clear and colorless.
water, and practically insoluble in ethanol (2) Carbonate or bicarbonate—Dissolve
(95), in ethanol (99.5) and in diethyl ether. 1.0 g of powdered Sodium Borate in 20 mL
When placed in dry air, Sodium Borate of freshly boiled and cooled water, and add 3
effloresces and is coated with a white powder. mL of dilute hydrochloric acid: the solution
does not effervesce.
Identification A solution of Sodium Borate (1 (3) Heavy metals <1.07>—Dissolve 1.5
in 20) responds to the Qualitative Tests g of Sodium Borate in 25 mL of water and 7
<1.09> for sodium salt and for borate. mL of 1 mol/L hydrochloric acid TS, add 1
• A. Sodium salt drop of phenolphthalein TS, and add
(1) When the Flame Coloration Test ammonia TS until a pale red color develops.
(1) <1.04> is applied to sodium salts, a Then add dilute acetic acid until the solution
yellow color develops. becomes colorless again, add 2 mL of dilute
(2) Concentrated, neutral or slightly acetic acid, and add water to make 50 mL.
alkaline solutions of sodium salts yield a Perform the test using this solution as the test
white, crystalline precipitate with potassium solution. Prepare the control solution as
hexahydroxoantimonate (V) TS. The follows: to 3.0 mL of Standard Lead Solution
formation of the precipitate is accelerated add 2 mL of dilute acetic acid and water to
by rubbing the inside wall of the test tube make 50 mL (not more than 20 ppm).
with a glass rod. (4) Arsenic <1.11>—Prepare the test
• B. Borate solution with 0.40 g of Sodium Borate
(1) When ignite a mixture of a borate according to Method 1, and perform the test
with sulfuric acid (not more than 5 ppm).
and methanol, it burns with a green flame.
(2) Turmeric paper, when moistened Assay Weigh accurately about 2 g of Sodium
with acidic solutions of borates in Borate, dissolve in 50 mL of water, and
titrate <2.50> with 0.5 mol/L hydrochloric boiling. Allow to cool in ice water and, if
acid VS (indicator: 3 drops of methyl red TS). necessary, rub the inside of the test tube
Each mL of 0.5 mol/L hydrochloric with a glass rod. A dense precipitate is
acid VS formed. Sodium compounds impart an
= 95.34 mg of Na2B4O7.10H2O
intense yellow color to a nonluminous
flame.”
Containers and storage Containers—Tight Sample Solution: 1 in 20
containers. Acceptance Criteria: Meets the
requirements
Source: Japanese Pharmacopeia XIV
• B. Identification Tests – General, Borate
******************************************** <191>
************** “To 1 mL of a borate solution, acidified with

Sodium Borate hydrochloric acid, bismuth salts yield a


white precipitate upon dilution with water.
Na2B4O7• 10H2O
This precipitate is colored brown by
381.37
hydrogen sulfide, and the resulting
Na2B4O7
compound dissolves in a warm mixture of
Borax [1303-96-4]
Anhydrous [1330- equal parts of nitric acid and water

43-4] Sample Solution: 1 in 20

Description Acceptance Criteria: Meets the

Sodium Borate contains an amount of requirements

Na2B4O7 equivalent to NLT 99.0% and NMT


Assay
105.0% of Na2B4O7 • 10 H2O.
• Procedure

Identification Sample: 150 mg

• A. Identification Tests – General, Blank: Glacial Acetic Acid

Sodium <191> Titrimetric System: (See Titrimetry

“Unless otherwise specified in an individual <541>)

monograph, prepare a solution to contain Mode: Direct titration

0.1 g of the sodium compound in 2 mL of Titrant: 0.5 N Hydrochloric Acid VS

water. Add 2 mL of 15% potassium Blank: 50 mL of water

carbonate, and heat to boiling. No Endpoint detection: Visual

precipitate is formed. Add 4 mL of Analysis: Dissolve the Sample in 50 mL

potassium pyroantimonate TS, and heat to of water, add methyl red TS, and titrate
with 0.5 N Hydrochloric Acid VS. [Note-
Heating on a steam bath may be required Source: United States Pharmacopoeia –
initially to effect solution.] National Formulary

Calculate the percentage of Sodium Borate


[Na2B4O7•10H2O] in the Sample taken:
Result = [(V=B) x N x F] x
100/W

V = Volume of Titrant consumed by the


Sample (mL)
B = Volume of Titrant consumed by the
Blank
Sample
N = Actual normality of the Titrant
(mEq/mL)
F = Equivalency factor, 190.7 mg/mEq
W = Weight of the Sample (mg)
Acceptable Criteria: 99.0%-105.0%

Impurities
• A. Heavy Metal <231>
Test Preparation: Dissolve 1 g in 16
mL of water and 6 mL of 1 N Hydrochloric
Acid. Dilute with water in 25 mL
Acceptance Criteria: NMT 20 ppm
• B. Carbonate and Bicarbonate
Sample Solution: To 5 mL of a
solution (1 in 20), contained in a test tube,
add 1 mL of 3 N Hydrochloric Acid.
Acceptance Criteria: No effervescence
is observed

Additional Requirements:
• A. Packaging and Storage: Preserve in
tight container.

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