Accessed from 128.83.63.

20 by nEwp0rt1 on Tue Nov 29 23:01:48 EST 2011

1872 Monoglyceride / Official Monographs NF 30

layer from the Standard solution and Sample solution against V = volume of Titrant consumed by the Sample (mL)
the aqueous layer from the Blank. B = volume of Titrant consumed by the Blank (mL)
Calculate the percentage of citric acid in the portion of N = actual normality of the Titrant (mEq/mL)
Monoglyceride Citrate taken: F = equivalency factor, 93.56 mg/mEq
W = weight of the Sample (mg)
Result = (AU/AS) × (V × CS/W) × 100 Acceptance criteria: 99.0%–100.5%
AU =absorbance of the Sample solution IMPURITIES
AS =absorbance of the Standard solution • CHLORIDE AND SULFATE, Chloride 〈221〉: A 280-mg portion
V =volume of the Sample solution (mL) shows no more chloride than corresponds to 1.0 mL of
CS =concentration of USP Citric Acid RS in the 0.020 N hydrochloric acid (0.25%).
Standard solution (mg/mL) • LEAD 〈251〉: NMT 10 ppm
W = weight of Monoglyceride Citrate taken to • HEAVY METALS, Method II 〈231〉: NMT 20 ppm
prepare the Sample solution (mg)
Acceptance criteria: 14.0%–17.0% on the anhydrous basis SPECIFIC TESTS
• CLARITY AND COLOR OF SOLUTION
IMPURITIES Sample solution: 1.0 g in 10 mL of water
• RESIDUE ON IGNITION 〈281〉: NMT 0.3%, determined on 1 g Standard solution: To 0.2 mL of a solution of sodium
• HEAVY METALS, Method II 〈231〉: NMT 10 ppm chloride containing 10 µg/mL of chloride ion (Cl), add 20
mL of water, and mix. Then add 1 mL of 5 N nitric acid, 0.2
SPECIFIC TESTS mL of dextrin solution (1 in 50), and 1 mL of silver nitrate
• FATS AND FIXED OILS, Acid Value 〈401〉: 70–100 TS, and allow to stand for 15 min.
• FATS AND FIXED OILS, Saponification Value 〈401〉: 260–265 Analysis: Compare the Sample solution with the Standard
• WATER DETERMINATION, Method I 〈921〉: NMT 0.2% solution (see Spectrophotometry and Light-Scattering—Visual
Comparison 〈851〉).
ADDITIONAL REQUIREMENTS Acceptance criteria: The Sample solution is colorless and has
• PACKAGING AND STORAGE: Preserve in well-closed containers. no more turbidity than the Standard solution.
No storage requirements specified. • OPTICAL ROTATION, Specific Rotation 〈781S〉
• USP REFERENCE STANDARDS 〈11〉 Sample solution: 100 mg/mL in 2 N hydrochloric acid
USP Citric Acid RS Acceptance criteria: +24.8° to +25.3°, determined at 20°
• PH 〈791〉: 6.7–7.2, in a solution (1 in 20)
• LOSS ON DRYING 〈731〉: Dry a sample at 100° for 5 h: it loses
.
NMT 0.5% of its weight.
Monosodium Glutamate ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers.
DEFINITION
Monosodium Glutamate contains NLT 99.0% and NMT 100.5%
of C5H8NNaO4 · H2O.
.

IDENTIFICATION
• A.
Monothioglycerol
Sample solution: 1 in 30
Analysis: To 1 mL of the Sample solution add 1 mL of
ninhydrin TS and 100 mg of sodium acetate, and heat in a
boiling water bath for 10 min.
Acceptance criteria: An intense, violet blue color is formed. C3H8O2S 108.16
• B. 1,2-Propanediol, 3-mercapto-.
Sample solution: 1 in 10 3-Mercapto-1,2-propanediol [96-27-5].
Analysis: To 10 mL of the Sample solution add 5.6 mL of
1 N hydrochloric acid. » Monothioglycerol contains not less than 97.0
Acceptance criteria: A white, crystalline precipitate of percent and not more than 101.0 percent of
glutamic acid is formed on standing. Precipitation is pro- C3H8O2S, calculated on the anhydrous basis.
moted by agitation. When 6 mL of 1 N hydrochloric acid is
added to the turbid solution, the glutamic acid dissolves on Packaging and storage—Preserve in tight containers.
stirring. Specific gravity 〈841〉: between 1.241 and 1.250.
• C. IDENTIFICATION TESTS—GENERAL, Sodium 〈191〉: It meets Refractive index 〈831〉: between 1.521 and 1.526.
the requirements of the pyroantimonate precipitate test.
pH 〈791〉: between 3.5 and 7.0, in a solution (1 in 10).
ASSAY Water, Method II 〈921〉: not more than 5.0%.
• PROCEDURE Residue on ignition 〈281〉: not more than 0.1%.
Sample: 250 mg Selenium 〈291〉: 0.003%, a 200-µL test specimen being
Titrimetric system used.
(See Titrimetry 〈541〉.)
Mode: Direct titration Heavy metals, Method II 〈231〉: 0.002%.
Titrant: 0.1 N perchloric acid VS Assay—Dissolve about 400 mg of Monothioglycerol, accurately
Blank: 100 mL of glacial acetic acid with a few drops of weighed, in 50 mL of water, and titrate with 0.1 N iodine VS,
water adding 3 mL of starch TS as the endpoint is approached. Each
Endpoint detection: Potentiometric mL of 0.1 N iodine is equivalent to 10.82 mg of C3H8O2S.
Analysis: Wet the Sample with a few drops of water. Dis-
solve in 100 mL of glacial acetic acid. Titrate with 0.1 N
perchloric acid VS. Perform a blank determination.
Calculate the percentage of monosodium glutamate
(C5H8NNaO4 · H2O) in the Sample taken:
Result = [(V − B) × N × F × 100]/W

Official from May 1, 2012

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