NF 31
not exceed 103 cfu/g. The total combined molds and • HEAVY METALS 〈231〉
yeasts count does not exceed 100 cfu/g.
• SPECIFIC GRAVITY 〈841〉: 1.400–1.435 at 20°
• REFRACTIVE INDEX 〈831〉: 1.4900–1.4992 at 20°
• WATER DETERMINATION, Method I 〈921〉: 15.0%–18.6%
• MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MI-
CROORGANISMS 〈2022〉: Where it is intended for use in
preparations for infants under one year of age, it meets
the requirements of the Test for Absence of Clostridium
Species.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers. No
storage requirements specified.
• LABELING: Label it to indicate that it is not intended for
use in preparations for infants under one year of age,
unless it meets the requirements of the Test for Absence of
Clostridium Species.
• USP REFERENCE STANDARDS 〈11〉
USP L-Proline RS
Hydrochloric Acid
.
HCl 36.46
Hydrochloric acid [7647-01-0].
DEFINITION
Hydrochloric Acid contains NLT 36.5% and NMT 38.0%, by
weight, of HCl.
IDENTIFICATION
• A. IDENTIFICATION TESTS—GENERAL, Chloride 〈191〉
ASSAY
• PROCEDURE
Sample: 3 mL
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Direct titration
Titrant: 1 N sodium hydroxide VS
Blank: 45 mL of water
Endpoint detection: Visual
Analysis: Place the Sample in a glass-stoppered flask,
previously tared while containing about 20 mL of water,
and weigh again to obtain the weight of the substance
under assay. Dilute with 25 mL of water, and add
methyl red TS. Titrate with 1 N sodium hydroxide VS.
Calculate the percentage of hydrochloric acid (HCl) in
the Sample taken:
Result = [(VS − VB) × N × F]/W × 100
VS = volume of Titrant consumed by the Sample
(mL)
VB = volume of Titrant consumed by the Blank (mL)
N = actual normality of the Titrant (mEq/mL)
F = equivalency factor, 36.46 mg/mEq
W = weight of the Sample (mg)
Acceptance criteria: 36.5%–38.0%
IMPURITIES
• RESIDUE ON IGNITION 〈281〉
Sample: 20 mL
Analysis: To the Sample, add 2 drops of sulfuric acid,
evaporate to dryness, and ignite.
Acceptance criteria: NMT 2 mg of residue remains
(about 0.008%).
Official Monographs / Hydrochloric 2037
Sample: 3.4 mL (4 g)
Analysis: Evaporate the Sample on a steam bath to
dryness, add 2 mL of 1 N acetic acid to the residue, and
dilute with water to 25 mL.
Acceptance criteria: NMT 5 ppm
SPECIFIC TESTS
• BROMIDE OR IODIDE
Sample solution: 1 part Hydrochloric Acid to 2 parts
water
Analysis: Add 1 mL of chloroform to 10 mL of the
Sample solution. Cautiously add, dropwise, with
constant agitation, chlorine TS that has been diluted
with an equal volume of water.
Acceptance criteria: The chloroform remains free from
even a transient yellow, orange, or violet color.
• FREE BROMINE OR CHLORINE
Sample solution: 1 part Hydrochloric Acid to 2 parts
water
Analysis: Add 1 mL of potassium iodide TS and 1 mL of
chloroform to 10 mL of the Sample solution, and agitate
the mixture.
Acceptance criteria: The chloroform remains free from
any violet color for at least 1 min.
• SULFATE
Sample solution: 1 part Hydrochloric Acid to 2 parts
water
Analysis: To a mixture of 3 mL of the Sample solution
and 5 mL of water, add 5 drops of barium chloride TS.
Acceptance criteria: Neither turbidity nor precipitate
appears within 1 h.
• SULFITE
Sample solution: 1 part Hydrochloric Acid to 2 parts
water
Analysis: Complete the test for Sulfate, then add to the
liquid 2 drops of 0.1 N iodine.
Acceptance criteria: Neither turbidity nor
decolorization of the iodine occurs.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers.
Diluted Hydrochloric Acid
.
DEFINITION
Diluted Hydrochloric Acid contains, in each 100 mL, NLT
9.5 g and NMT 10.5 g of hydrochloric acid (HCl).
Diluted Hydrochloric Acid may be prepared as follows.
Hydrochloric Acid 226 mL
Purified Water, a sufficient quantity to make 1000 mL
Mix the ingredients.
IDENTIFICATION
• A. IDENTIFICATION TESTS—GENERAL, Chloride 〈191〉
ASSAY
• PROCEDURE
Sample: 10.0 mL
Blank: 20 mL of water
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Direct titration
Titrant: 1 N sodium hydroxide VS
Endpoint detection: Visual
Analysis: Transfer the Sample to a conical flask, and add
about 20 mL of water. Add 3 drops of methyl red TS.
Titrate with Titrant. Perform a blank determination.
2038 Hydrochloric / Official Monographs
Calculate the amount of hydrochloric acid (HCl) in the
portion of sample taken:
Result = (VS − VB) × N × F
VS = Titrant volume consumed by the Sample (mL)
VB = Titrant volume consumed by the Blank (mL)
N = actual normality of the Titrant (mEq/mL)
F = equivalency factor, 3.646 × 10−2 g/mEq
Acceptance criteria: 9.5–10.5 g of HCl in each 100 mL
IMPURITIES
• RESIDUE ON IGNITION 〈281〉
Sample: 20 mL
Analysis: To the Sample add 2 drops of sulfuric acid,
evaporate to dryness, and ignite.
Acceptance criteria: NMT 2 mg
• HEAVY METALS 〈231〉
Test preparation: To 3.8 mL (4 g) of Diluted
Hydrochloric Acid add 5 mL of water and 1 drop of
phenolphthalein TS. Add 6 N ammonium hydroxide
until the solution assumes a faint pink color. Add 2 mL
of 1 N acetic acid, then add water to make 25 mL.
Acceptance criteria: NMT 5 µg/g
• FREE BROMINE OR CHLORINE
Sample: 10 mL
Analysis: To the Sample add 1 mL of potassium iodide
TS and 1 mL of chloroform, and agitate the mixture.
Acceptance criteria: The chloroform remains free from
any violet coloration for at least 1 min.
• SULFATE
Sample solution: Mix 3 mL of Diluted Hydrochloric
Acid and 5 mL of water.
Analysis: To the Sample solution add 5 drops of barium
chloride TS.
Acceptance criteria: Neither turbidity nor precipitate
appears within 1 h.
• SULFITE
Analysis: Complete the test for Sulfate, then add to the
liquid 2 drops of 0.1 N iodine.
Acceptance criteria: Neither turbidity nor
decolorization of the iodine occurs.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers.
Hydroxyethyl Cellulose
.
Cellulose, 2-hydroxyethyl ether [9004-62-0].
DEFINITION
Hydroxyethyl Cellulose is a partially substituted poly(hydrox-
yethyl) ether of cellulose. It is available in several grades,
varying in viscosity and degree of substitution, and some
grades are modified to improve their dispersion in water.
It may contain suitable anticaking agents.
IDENTIFICATION
• A.
Sample solution: 1 g in 100 mL of water
Analysis: Stir the Sample solution.
Acceptance criteria: It dissolves completely to produce
a colloidal solution that remains clear when heated to
60°.
• B.
Sample: 1 mL of the solution from Identification test A
Analysis: Place the Sample on a glass plate, and allow
to evaporate.
Acceptance criteria: A thin, self-sustaining film is
formed.
NF 31
• C.
Sample solution: 1 in 2000
Analysis: To 1 mL of the Sample solution add 1 mL of
phenol solution (50 mg/mL), then add 5 mL of sulfuric
acid, shake, and allow to cool.
Acceptance criteria: The color of the solution becomes
orange.
IMPURITIES
• RESIDUE ON IGNITION 〈281〉: NMT 5.0%
• LEAD 〈251〉: NMT 10 µg/g
• HEAVY METALS, Method II 〈231〉: NMT 20 µg/g
SPECIFIC TESTS
• PH 〈791〉
Sample solution: 10 mg/mL
Acceptance criteria: 6.0–8.5
• LOSS ON DRYING 〈731〉
Analysis: Dry at 105° for 3 h.
Acceptance criteria: NMT 10.0%
• VISCOSITY—CAPILLARY VISCOMETER METHODS 〈911〉 and RO-
TATIONAL RHEOMETER METHODS 〈912〉: When determined
at the concentration and under the conditions specified
in the labeling, its viscosity is NLT 50% and NMT 150%
of the labeled viscosity, where stated as a single value, or
it is between the maximum and minimum values, where
stated as a range of viscosities.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed
containers.
• LABELING: The labeling indicates its viscosity, under speci-
fied conditions, in aqueous solution. The indicated viscos-
ity may be in the form of a range encompassing
50%–150% of the average value.
Hydroxypropyl Betadex
.
C42H70O35(C3H6O)x where x = 7 × MS, MS being molar
substitution
Beta cyclodextrin, 2-hydroxypropyl ether [94035-02-6].
DEFINITION
Hydroxypropyl Betadex is a partially substituted
poly(hydroxypropyl) ether of Betadex. The number of
hydroxypropyl groups per anhydroglucose unit expressed
as molar substitution (MS) is NLT 0.40 and NMT 1.50 and
is within 10% of the value stated on the label.
IDENTIFICATION
• A. INFRARED ABSORPTION 〈197K〉: The spectrum obtained
with Hydroxypropyl Betadex shows the same absorption
bands as the spectrum acquired with USP Hydroxypropyl
Betadex RS. Due to the difference in the substitution of
the substance, the intensity of some absorption bands
may vary.