Accessed from 190.144.42.

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6200 Sodium / Official Monographs USP 40

Table 2 (Continued) Sample solution: Shake thoroughly by hand each bot-

Relative Acceptance
tle of Oral Suspension. Prepare 0.1 mg/mL of sodium
Retention Criteria,
phenylbutyrate from Oral Suspension and Mobile phase.
Name Time NMT (%)
Chromatographic system
(See Chromatography 621, System Suitability.)
Any individual unspecified Mode: LC

Impurity 0.05 Detector: UV 218 nm
Total impurities 0.1 Column: 4.6-mm 25-cm; 5-m packing L1
Column temperature: 60
SPECIFIC TESTS Flow rate: 1.0 mL/min
WATER DETERMINATION, Method Ia 921: NMT 0.5% Injection volume: 5 L
PH 791 System suitability
Sample solution: 20 mg/mL in carbon dioxide-free Sample: Standard solution
water [NOTEThe retention time for sodium phenylbutyrate is
Acceptance criteria: 6.57.5 about 3.0 min.]
Suitability requirements
ADDITIONAL REQUIREMENTS Relative standard deviation: NMT 2.0% for replicate
PACKAGING AND STORAGE: Preserve under argon in tight injections
containers. Store at room temperature. Analysis
USP REFERENCE STANDARDS 11 Samples: Standard solution and Sample solution
USP Sodium Phenylbutyrate RS Calculate the percentage of the labeled amount of so-
USP Phenylbutyrate Related Compound A RS dium phenylbutyrate (C10H11O2Na) in the portion of
3-Benzoylpropionic acid; Oral Suspension taken:
4-Oxo-4-phenylbutanoic acid.
C10H10O3 178.18 Result = (rU/rS) (CS/CU) 100
USP Phenylbutyrate Related Compound B RS
-Tetralone; rU = peak response from the Sample solution
3,4-Dihydronaphthalen-1(2H)-one. rS = peak response from the Standard solution
C10H10O 146.19 CS = concentration of sodium phenylbutyrate in the
USP Phenylbutyrate Related Compound C RS Standard solution (mg/mL)
4-Cyclohexylbutanoic acid. CU = nominal concentration of sodium
C10H18O2 170.25 phenylbutyrate in the Sample solution
(mg/mL)
Acceptance criteria: 90.0%110.0%
SPECIFIC TESTS
.

PH 791: 7.08.0
Sodium Phenylbutyrate Compounded
USP Monographs

Oral Suspension ADDITIONAL REQUIREMENTS

DEFINITION
Sodium Phenylbutyrate Compounded Oral Suspension con-
tains NLT 90.0% and NMT 110.0% of the labeled amount
of sodium phenylbutyrate (C10H11O2Na).
Prepare Sodium Phenylbutyrate Compounded Oral Suspen-
sion 200 mg/mL as follows (see Pharmaceutical Compound-
ingNonsterile Preparations 795).
PACKAGING AND STORAGE: Package in tight, light-resistant
containers. Store at controlled room temperature.
BEYOND-USE DATE: NMT 90 days after the date on which
it was compounded when stored at controlled room
temperature
LABELING: Label it to indicate that it is to be well shaken
before use, and to state the Beyond-Use Date.

Sodium Phenylbutyrate powdera . 20 g .

Vehicle: a 1:1 mixture of Ora-Sweetb (reg-.

Dibasic Sodium Phosphate

ular or sugar-free) and Ora-Plus,b a suffi-
.

cient quantity to make 100 mL

Na2HPO4 12H2O 358.14
a UcyclydPharma, Inc., Scottsdale, AZ.
Na2HPO4 7H2O 268.07
.

b Paddock Laboratories, Minneapolis, MN.

.

Calculate the required quantity of each ingredient for the
total amount to be prepared. Place the Sodium
Phenylbutyrate powder in a suitable mortar, and commi-
nute to a fine powder with a pestle. Add the Vehicle in
small portions, and triturate to make a smooth paste. Add
increasing volumes of the Vehicle to make a sodium
phenylbutyrate liquid that is pourable. Transfer the con-
tents of the mortar, stepwise and quantitatively, to a cali-
brated bottle. Add enough of the Vehicle to bring to final
volume, and mix well.
ASSAY
PROCEDURE
Mobile phase: Acetonitrile and 5 mM phosphoric acid
(40:60). Filter and degas.
Standard solution: 0.1 mg/mL of sodium
phenylbutyrate in Mobile phase. [NOTEThe Standard
solution should be prepared from the appropriate refer-
ence material.]
Na2HPO4 2H2O 177.99
Na2HPO4 H2O 159.94
Na2HPO4 141.96
Phosphoric acid, disodium salt, dodecahydrate;
Disodium hydrogen phosphate, dodecahydrate
[10039-32-4].
Phosphoric acid, disodium salt, heptahydrate;
Disodium hydrogen phosphate heptahydrate [7782-85-6].
Phosphoric acid, disodium salt, dihydrate;
Disodium hydrogen phosphate, dihydrate [10028-24-7].
Phosphoric acid, sodium salt, monohydrate;
Disodium hydrogen phosphate, monohydrate
[118830-14-1].
Phosphoric acid, disodium salt, hydrate;
Disodium hydrogen phosphate hydrate [10140-65-5].
Anhydrous [7558-79-4].

Official from August 1, 2017

Copyright (c) 2017 The United States Pharmacopeial Convention. All rights reserved.
Accessed from 190.144.42.125 by JNJconsumer on Fri Aug 18 10:18:16 EDT 2017

USP 40 Official Monographs / Sodium 6201

DEFINITION Standard Lead Solution and 11 mL of water to a third

Dibasic Sodium Phosphate is dried or contains one, two, color-comparison tube (Standard Preparation). Proceed
seven, or twelve molecules of water of hydration. It con- as directed for Procedure, omitting the dilution to
tains NLT 98.0% and NMT 100.5% of Na2HPO4, calcu- 50 mL.
lated on the dried basis. Acceptance criteria: NMT 20 ppm (Official 1-Jan-2018)
IDENTIFICATION SPECIFIC TESTS
A. IDENTIFICATION TESTSGENERAL, Sodium 191 LOSS ON DRYING 731: Dry a sample at 130 to constant
Sample solution: Equivalent to 1 part of Na2HPO4 in 30 weight.
Acceptance criteria: The solution meets the Acceptance criteria: See Table 1.
requirements.
B. IDENTIFICATION TESTSGENERAL, Phosphate 191 Table 1
Sample solution: Equivalent to 1 part of Na2HPO4 in 30
Acceptance criteria: The solution meets the Hydrate Form Acceptance Criteria
requirements. Dried NMT 5.0%
Monohydrate 10.3%12.0%
ASSAY
Dihydrate 18.5%21.5%
PROCEDURE
Sample: Equivalent to 2.5 g of Na2HPO4 Heptahydrate 43.0%50.0%
Sample solution: Transfer the Sample to a 250-mL Dodecahydrate 55.0%64.0%
beaker. Add 50 mL of water and 40.0 mL of 1 N hydro-
chloric acid, and stir until dissolved. ADDITIONAL REQUIREMENTS
Blank: Transfer 40.0 mL of 1 N hydrochloric acid to a PACKAGING AND STORAGE: Preserve in tight containers.
250-mL beaker. Add 50 mL of water. LABELING: Label it to indicate whether it is dried or is the
Analysis: Titrate the Blank with 1 N sodium hydroxide monohydrate, the dihydrate, the heptahydrate, or the
VS, and record the volume of 1 N sodium hydroxide VS dodecahydrate.
consumed. Titrate the excess acid in the Sample solution
potentiometrically with 1 N sodium hydroxide VS to the
inflection point at about pH 4, and record the buret
reading. Subtract this buret reading from that of the
Blank, and designate the volume of 1 N sodium hydrox-
.

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;

to 142.0 mg of Na2HPO4. Where A is greater than B,
each mL of the volume (2B A) of 1 N sodium hydrox-
ide is equivalent to 142.0 mg of Na2HPO4.
Acceptance criteria: 98.0%100.5% on the dried basis
IMPURITIES
INSOLUBLE SUBSTANCES
Sample solution: Equivalent to 5.0 g of Na2HPO4 in
100 mL of hot water
Analysis: Filter through a tared filtering crucible, wash
the insoluble residue with hot water, and dry at 105
for 2 h.
Acceptance criteria: NMT 20 mg (NMT 0.4%)
CHLORIDE AND SULFATE, Chloride 221
Sample: Equivalent to 0.5 g of Na2HPO4
Acceptance criteria: Shows no more chloride than cor-
responds to 0.42 mL of 0.020 N hydrochloric acid
(NMT 0.06%)
CHLORIDE AND SULFATE, Sulfate 221
Sample: Equivalent to 0.1 g of Na2HPO4
Acceptance criteria: Shows no more sulfate than corre-
sponds to 0.2 mL of 0.020 N sulfuric acid (NMT 0.2%)
ARSENIC, Method I 211
Test preparation: Equivalent to 187.5 mg of Na2HPO4
in 35 mL of water
Acceptance criteria: NMT 16 ppm
Delete the following:
HEAVY METALS 231
.
USP Monographs
Monosodium phosphate monohydrate [10049-21-5].
Phosphoric acid, monosodium salt, dihydrate;
Monosodium phosphate dihydrate [13472-35-0].
Anhydrous [7558-80-7].
DEFINITION
Monobasic Sodium Phosphate contains one or two mole-
cules of water of hydration, or is anhydrous. It contains
NLT 98.0% and NMT 103.0% of monobasic sodium
phosphate (NaH2PO4), calculated on the anhydrous basis.
IDENTIFICATION
A. IDENTIFICATION TESTSGENERAL, Sodium 191
Sample solution: 50 mg/mL
Acceptance criteria: Meets the requirements
B. IDENTIFICATION TESTSGENERAL, Phosphate 191
Sample solution: 50 mg/mL
Acceptance criteria: Meets the requirements
ASSAY
PROCEDURE
Sample: 2.5 g
Titrimetric system
(See Titrimetry 541.)
Mode: Direct titration
Titrant: 1 N sodium hydroxide VS
Endpoint detection: Visual
Analysis: Dissolve the Sample in 10 mL of cold water.
Add 20 mL of a cold, saturated solution of sodium chlo-
ride, add phenolphthalein TS, and then titrate with Ti-
trant, keeping the temperature of the solution between
10 and 15 during the entire titration. Perform a blank

Sample stock solution: Dissolve the equivalent to 2.1 g

of Na2HPO4 in enough water to make 50 mL.
Analysis: Transfer 12 mL of the Sample stock solution to
a 50-mL color-comparison tube (Test Preparation).
Transfer 11 mL of the Sample stock solution to a second
color-comparison tube containing 1.0 mL of Standard
Lead Solution (Monitor Preparation). Transfer 1.0 mL of
determination, and make any necessary correction. Each
mL of Titrant is equivalent to 120.0 mg of monobasic
sodium phosphate (NaH2PO4).
Acceptance criteria: 98.0%103.0% on the anhydrous
basis

Official from August 1, 2017

Copyright (c) 2017 The United States Pharmacopeial Convention. All rights reserved.