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PH 791: 7.08.0
Sodium Phenylbutyrate Compounded
USP Monographs
Calculate the required quantity of each ingredient for the Na2HPO4 2H2O 177.99
total amount to be prepared. Place the Sodium Na2HPO4 H2O 159.94
Phenylbutyrate powder in a suitable mortar, and commi- Na2HPO4 141.96
nute to a fine powder with a pestle. Add the Vehicle in Phosphoric acid, disodium salt, dodecahydrate;
small portions, and triturate to make a smooth paste. Add Disodium hydrogen phosphate, dodecahydrate
increasing volumes of the Vehicle to make a sodium [10039-32-4].
phenylbutyrate liquid that is pourable. Transfer the con- Phosphoric acid, disodium salt, heptahydrate;
tents of the mortar, stepwise and quantitatively, to a cali- Disodium hydrogen phosphate heptahydrate [7782-85-6].
brated bottle. Add enough of the Vehicle to bring to final Phosphoric acid, disodium salt, dihydrate;
volume, and mix well. Disodium hydrogen phosphate, dihydrate [10028-24-7].
ASSAY Phosphoric acid, sodium salt, monohydrate;
PROCEDURE Disodium hydrogen phosphate, monohydrate
Mobile phase: Acetonitrile and 5 mM phosphoric acid [118830-14-1].
(40:60). Filter and degas. Phosphoric acid, disodium salt, hydrate;
Standard solution: 0.1 mg/mL of sodium Disodium hydrogen phosphate hydrate [10140-65-5].
phenylbutyrate in Mobile phase. [NOTEThe Standard Anhydrous [7558-79-4].
solution should be prepared from the appropriate refer-
ence material.]
ide VS resulting from this subtraction as A. Continue the Monobasic Sodium Phosphate
titration with 1 N sodium hydroxide VS to the inflection
point at about pH 8.8, record the buret reading, and NaH2PO4 119.98
calculate the volume (B) of 1 N sodium hydroxide re- NaH2PO4 H2O 137.99
quired in the titration between the two inflection points
(pH 48.8). Where A is equal to or less than B, each mL NaH2PO4 2H2O 156.01
of the volume A of 1 N sodium hydroxide is equivalent Phosphoric acid, monosodium salt, monohydrate;
USP Monographs
to 142.0 mg of Na2HPO4. Where A is greater than B, Monosodium phosphate monohydrate [10049-21-5].
each mL of the volume (2B A) of 1 N sodium hydrox- Phosphoric acid, monosodium salt, dihydrate;
ide is equivalent to 142.0 mg of Na2HPO4. Monosodium phosphate dihydrate [13472-35-0].
Acceptance criteria: 98.0%100.5% on the dried basis Anhydrous [7558-80-7].
IMPURITIES DEFINITION
INSOLUBLE SUBSTANCES Monobasic Sodium Phosphate contains one or two mole-
Sample solution: Equivalent to 5.0 g of Na2HPO4 in cules of water of hydration, or is anhydrous. It contains
100 mL of hot water NLT 98.0% and NMT 103.0% of monobasic sodium
Analysis: Filter through a tared filtering crucible, wash phosphate (NaH2PO4), calculated on the anhydrous basis.
the insoluble residue with hot water, and dry at 105
for 2 h. IDENTIFICATION
Acceptance criteria: NMT 20 mg (NMT 0.4%) A. IDENTIFICATION TESTSGENERAL, Sodium 191
CHLORIDE AND SULFATE, Chloride 221 Sample solution: 50 mg/mL
Sample: Equivalent to 0.5 g of Na2HPO4 Acceptance criteria: Meets the requirements
Acceptance criteria: Shows no more chloride than cor- B. IDENTIFICATION TESTSGENERAL, Phosphate 191
responds to 0.42 mL of 0.020 N hydrochloric acid Sample solution: 50 mg/mL
(NMT 0.06%) Acceptance criteria: Meets the requirements
CHLORIDE AND SULFATE, Sulfate 221 ASSAY
Sample: Equivalent to 0.1 g of Na2HPO4 PROCEDURE
Acceptance criteria: Shows no more sulfate than corre- Sample: 2.5 g
sponds to 0.2 mL of 0.020 N sulfuric acid (NMT 0.2%) Titrimetric system
ARSENIC, Method I 211 (See Titrimetry 541.)
Test preparation: Equivalent to 187.5 mg of Na2HPO4 Mode: Direct titration
in 35 mL of water Titrant: 1 N sodium hydroxide VS
Acceptance criteria: NMT 16 ppm Endpoint detection: Visual
Analysis: Dissolve the Sample in 10 mL of cold water.
Delete the following: Add 20 mL of a cold, saturated solution of sodium chlo-
ride, add phenolphthalein TS, and then titrate with Ti-
HEAVY METALS 231 trant, keeping the temperature of the solution between
10 and 15 during the entire titration. Perform a blank
.