Accessed from 177.67.60.
190 by luis7 on Wed Mar 14 07:25:57 EDT 2018
USP 40
Relative standard deviation: NMT 5.0% from the
milrinone peak
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of each impurity in the por-
tion of Milrinone taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response of each impurity from the
Sample solution
rS = peak response of milrinone from the Standard
solution
CS = concentration of USP Milrinone RS in the
Standard solution (mg/mL)
CU = concentration of Milrinone in the Sample
solution (mg/mL)
Acceptance criteria
Any individual impurity: NMT 0.3%
Total impurities: NMT 1.0%
SPECIFIC TESTS
• WATER DETERMINATION, Method I 〈921〉: NMT 2.0%
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers,
and store at controlled room temperature.
• USP REFERENCE STANDARDS 〈11〉
USP Milrinone RS
USP Milrinone Related Compound A RS
1,6-Dihydro-2-methyl-6-oxo-(3,4′-bipyridine)-
5-carboxamide.
C12H11N3O2 229.23
.
Mineral Oil
DEFINITION
Mineral Oil is a purified mixture of liquid hydrocarbons ob-
tained from petroleum. It may contain a suitable
stabilizer.
IDENTIFICATION
• A. INFRARED ABSORPTION 〈197F〉
• B. It meets the requirements in Specific Tests for Viscos-
ity—Capillary Methods 〈911〉.
IMPURITIES
• LIMIT OF POLYCYCLIC AROMATIC HYDROCARBONS
Dimethyl sulfoxide: Use spectrophotometric grade di-
methyl sulfoxide.
n-Hexane: Use n-hexane that has been washed by be-
ing shaken previously twice with one-fifth its volume of
Dimethyl sulfoxide.
Standard solution: 7.0 µg/mL of USP Naphthalene RS
in isooctane (2,2,4-trimethylpentane)
Standard blank: 2,2,4-Trimethylpentane
Sample solution: Transfer 25.0 mL of Mineral Oil and
25 mL of n-Hexane to a 125-mL separator, and mix.
[NOTE—Use no lubricants other than water on the stop-
cock, or use a separator equipped with a suitable poly-
meric stopcock.]
Add 5.0 mL of Dimethyl sulfoxide, and shake the mixture
vigorously for 1 min. Allow to stand until the lower
layer is clear, transfer the lower layer to another
125-mL separator, add 2 mL of n-Hexane, and shake
vigorously. Use the lower layer.
Sample blank: Dimethyl sulfoxide that has been shaken
previously vigorously for 1 min with n-Hexane in the
ratio of 5 mL of Dimethyl sulfoxide to 25 mL of n-Hexane
Official from December 1, 2017
Copyright (c) 2018 The United States Pharmacopeial Convention. All rights reserved.
Official Monographs / Mineral 5173
Instrumental conditions
Mode: UV
Analytical wavelengths
Standard solution: 275 nm
Sample solution: 260–350 nm
Cell: 1 cm
Analysis
Samples: Standard solution, Standard blank, Sample so-
lution, and Sample blank
Acceptance criteria: The absorbance at any wavelength
in the specified range of the Sample solution is NMT
one-third of the absorbance of the Standard solution.
SPECIFIC TESTS
• SPECIFIC GRAVITY 〈841〉: 0.845–0.905
• VISCOSITY—CAPILLARY METHODS 〈911〉: 34.5–150.0 mm2 · .
s–1 for kinematic viscosity, measured with a capillary vis-
.
cometer at 40 ± 0.1°
• ACIDITY
Sample: 10 mL
Analysis: Add 20 mL of boiling water to the Sample,
and shake vigorously for about 1 min. Allow to cool,
and draw off the separated water. To 10 mL of the
filtered aqueous layer add 0.1 mL of phenolphthalein
TS.
Acceptance criteria: The solution does not produce a
pink color. NMT 1.0 mL of 0.01 N sodium hydroxide is
required to to produce a pink color.
• READILY CARBONIZABLE SUBSTANCES TEST 〈271〉
Sample: 5 mL
Standard solution: In a glass-stoppered test tube that
previously has been rinsed with hot nitric acid (see
Cleaning Glass Apparatus 〈1051〉), mix 3 mL of ferric
chloride CS, 1.5 mL of cobaltous chloride CS, and
0.5 mL of cupric sulfate CS then overlaid with 5 mL of
Mineral Oil.
Analysis: Place the Sample in a glass-stoppered test
tube that previously has been rinsed with hot nitric acid
USP Monographs
(see Cleaning Glass Apparatus 〈1051〉), then rinsed with
water, and dried. Add 5 mL of sulfuric acid containing
94.5%–94.9% of H2SO4, and heat in a boiling water
bath for 10 min. After the test tube has been in the
bath for 30 s, remove it quickly, and while holding the
stopper in place, give three vigorous, vertical shakes
over an amplitude of about 5 in. Repeat every 30 s. Do
not keep the test tube out of the bath longer than 3 s
for each shaking period. At the end of 10 min from the
time when first placed in the water bath, remove the
test tube.
Acceptance criteria: The oil portion of the Sample may
turn hazy, but it remains colorless or shows a slight
pink or yellow color, and the acid portion of the Sample
does not become darker than the Standard solution.
• SOLID PARAFFIN
Sample: Mineral Oil that has been dried previously in a
beaker at 105° for 2 h and cooled to room temperature
in a desiccator over silica gel
Analysis: Fill a tall, cylindrical, standard oil-sample bot-
tle of colorless glass of 120-mL capacity with the Sam-
ple, insert the stopper, and immerse in an ice bath for 4
h.
Acceptance criteria: The Sample is sufficiently clear that
a black line 0.5 mm in width, on a white background,
held vertically behind the bottle, is clearly visible.
• LIMIT OF SULFUR COMPOUNDS
Solution A: Saturated solution of lead(II) oxide in so-
dium hydroxide (200 mg/mL)
Sample: 4.0 mL
Analysis: Combine the Sample, 2 mL of dehydrated al-
cohol, and 2 drops of Solution A, heat at 70° for 10 min
with frequent shaking, and cool.
 Accessed from 177.67.60.190 by luis7 on Wed Mar 14 07:25:57 EDT 2018

5174 Mineral / Official Monographs USP 40

Acceptance criteria: No dark brown color develops. ADDITIONAL REQUIREMENTS

• PACKAGING AND STORAGE: Preserve in tight, light-resistant,
ADDITIONAL REQUIREMENTS single-unit containers. No storage requirements specified.
• PACKAGING AND STORAGE: Preserve in tight, light-resistant • USP REFERENCE STANDARDS 〈11〉
containers. No storage requirements specified. USP Mineral Oil RS
• LABELING: Label it to indicate the name and quantity of
any substance added as a stabilizer.
• USP REFERENCE STANDARDS 〈11〉
USP Mineral Oil RS
USP Naphthalene RS
.

Topical Light Mineral Oil

DEFINITION
Topical Light Mineral Oil is Light Mineral Oil that has been
suitably packaged.
.

Mineral Oil Emulsion

IDENTIFICATION
DEFINITION • A. INFRARED ABSORPTION 〈197F〉
Prepare Mineral Oil Emulsion as follows. • B. It meets the requirements in Specific Tests for Viscos-
ity—Capillary Methods 〈911〉.
Mineral Oil 500 mL
SPECIFIC TESTS
Acacia, in very fine powder 125 g • SPECIFIC GRAVITY 〈841〉: 0.818–0.880
Syrup 100 mL • VISCOSITY—CAPILLARY METHODS 〈911〉: 3.0–34.4 mm2 · s−1 . .

Vanillin 40 mg for kinematic viscosity, measured with a capillary viscom-

Alcohol 60 mL
Purified Water, a sufficient quantity to make 1000 mL
Mix the Mineral Oil with the Acacia in a dry mortar. Add
250 mL of Purified Water all at once, and emulsify the mix-
ture. Add, in divided portions, triturating after each addi-
tion, a mixture of the Syrup, 50 mL of Purified Water, and
Vanillin dissolved in Alcohol. Add Purified Water to bring
the preparation to final volume, and mix.
The Vanillin may be replaced by NMT 1% of any other offi-
cial flavoring substance or any mixture of official flavoring
substances. Alcohol may be replaced with 60 mL of sweet
orange peel tincture or 2 g of benzoic acid as a
preservative.
USP Monographs
eter at 40 ± 0.1°
• ACIDITY
Sample: 10 mL
Analysis: Add 20 mL of boiling water to the Sample,
and shake vigorously for about 1 min. Allow to cool,
and draw off the separated water. To 10 mL of the
filtered aqueous layer add 0.1 mL of phenolphthalein
TS.
Acceptance criteria: The solution does not produce a
pink color. NMT 1.0 mL of 0.01 N sodium hydroxide is
required to produce a pink color.
• SOLID PARAFFIN
Sample: Topical Light Mineral Oil that has been dried
previously in a beaker at 105° for 2 h and cooled to

room temperature in a desiccator over silica gel

SPECIFIC TESTS Analysis: Fill a tall, cylindrical, standard oil-sample bot-
• ALCOHOL DETERMINATION, Method I 〈611〉: 4.0%–6.0% of tle of colorless glass of 120-mL capacity with the Sam-
C2H5OH ple. Insert the stopper, and immerse the bottle in a mix-
ture of ice and water for 4 h.
ADDITIONAL REQUIREMENTS Acceptance criteria: The Sample solution is sufficiently
• PACKAGING AND STORAGE: Package in tight containers. clear that a black line 0.5 mm in width, on a white
background, held vertically behind the bottle, is clearly
visible.
.

ADDITIONAL REQUIREMENTS
Mineral Oil, Rectal • PACKAGING AND STORAGE: Preserve in tight, light-resistant
containers. No storage requirements specified.
DEFINITION • LABELING: Label it to indicate the name and quantity of
Mineral Oil, Rectal, is Mineral Oil that has been suitably any substance added as a stabilizer, and label packages
packaged. intended for direct use by the public to indicate that it is
not intended for internal use.
IDENTIFICATION • USP REFERENCE STANDARDS 〈11〉
• A. INFRARED ABSORPTION 〈197F〉 USP Mineral Oil RS
• B. It meets the requirements in Specific Tests for Viscos-
ity—Capillary Methods 〈911〉.
SPECIFIC TESTS .

• SPECIFIC GRAVITY 〈841〉: 0.845–0.905 Minocycline for Injection

• VISCOSITY—CAPILLARY METHODS 〈911〉: 34.5–150.0 mm2 · .

s−1 for kinematic viscosity, measured with a capillary vis-

.

cometer at 40 ± 0.1°
• ACIDITY
Sample: 10 mL
Analysis: Add 20 mL of boiling water to the Sample,
and shake vigorously for about 1 min. Allow to cool,
and draw off the separated water. To 10 mL of the
filtered aqueous layer add 0.1 mL of phenolphthalein
TS.
Acceptance criteria: The solution does not produce a
pink color. NMT 1.0 mL of 0.01 N sodium hydroxide is
required to produce a pink color.
DEFINITION
Minocycline for Injection is sterile, freeze-dried Minocycline
Hydrochloride suitable for parenteral use. It contains the
equivalent of NLT 90.0% and NMT 120.0% of the labeled
amount of minocycline (C23H27N3O7).
IDENTIFICATION
• A. The retention time of the major peak of the Sample
solution corresponds to that of the Standard solution, as
obtained in the Assay.

Official from December 1, 2017

Copyright (c) 2018 The United States Pharmacopeial Convention. All rights reserved.