How to Use the USP–NF Errata Table

  • Searching: Type keyword in search field at top of page. Search by all or part of a monograph title. For searches using multiple criteria, you will find items that match each of the specified criteria unless quotation marks are used.
    • For example, a search on Aminosalicylic Acid Tablets will result in anything that contains “Aminosalicyclic” OR “Acid” OR “Tablets”
    • A search for “Aminosalicylic Acid Tablets” will result in anything that specifically contains “Aminosalicylic Acid Tablets”
  • Sorting: Click on any blue column header title to sort alphabetically or chronologically in ascending or descending order. Note: the page load column is sorted alphabetically so that a number is ordered by first digit vs. by the actual number; thus, numbers will not always be in order.
    • For example, page 2178 will come before page 74 on a page sort.
  • Downloading: You can download the Errata table in Comma-separated Value (.csv) or Excel format (.xls). The download will include all Errata from the database.
  • Printing: The table will print the view of the data as it has been filtered or sorted. To print a table of all Errata in the database, clear any keyword searches you have applied and select “Show: All”.
Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description

AMINOBENZOIC ACID

IMPURITIES/Organic Impurities

USP37–NF32

1730 01-Apr-2015

USP39–NF34

USP39–NF34

Add the subsection:
Standard stock solution: 0.25 mg/mL each of USP Benzocaine RS and 4-nitrobenzoic acid in methanol

AND
Line 2 of Standard solution: Change
in Mobile phase

to:
in Mobile phase, from the Standard stock solution

Add the subsection:
Standard stock solution: 0.25 mg/mL each of USP Benzocaine RS and 4-nitrobenzoic acid in methanol

AND
Line 2 of Standard solution: Change
in Mobile phase

to:
in Mobile phase, from the Standard stock solution

ASPARTAME

ASSAY/Procedure

USP37–NF32

5857 01-Apr-2015

USP39–NF34

USP39–NF34

Line 3 of Analysis: Change
crystal violet
to:
crystal violet TS

Line 3 of Analysis: Change
crystal violet
to:
crystal violet TS

BETAMETHASONE DIPROPIONATE

ASSAY/Procedure

USP37–NF32

1961 01-Apr-2015

USP39–NF34

USP39–NF34

Line 2 of Sample solution: Change
5.0 mL each of the Internal standard solution and the Standard stock solution

to:
5.0 mL each of the Internal standard solution and the Sample stock solution

Line 2 of Sample solution: Change
5.0 mL each of the Internal standard solution and the Standard stock solution

to:
5.0 mL each of the Internal standard solution and the Sample stock solution

BISMUTH SUBCARBONATE

IMPURITIES/Limit of Lead

USP38–NF33

2449 01-Apr-2015

USP39–NF34

USP39–NF34

Line 1 of Acceptance criteria: Change
Meets the requirements
to:
NMT 0.002%

Line 1 of Acceptance criteria: Change
Meets the requirements
to:
NMT 0.002%

BUTORPHANOL TARTRATE NASAL SOLUTION

IMPURITIES/Organic Impurities

First Supplement to USP37–NF32

6596 01-Apr-2015

USP39–NF34

USP39–NF34

Row 3 of Column 1 of Table 1: Change
6-Butorphanol
to:
Δ6-Butorphanol

Row 3 of Column 1 of Table 1: Change
6-Butorphanol
to:
Δ6-Butorphanol

CISATRACURIUM BESYLATE INJECTION

ASSAY/Procedure

USP38–NF33

2830 01-Apr-2015

USP39–NF34

USP39–NF34

Line 11 of Analysis: Change
CS
= concentration of USP Cisatracurium Besylate RS in the Standard solution

to:
CS
=
concentration of USP Cisatracurium Besylate RS in the Standard solution (mg/mL)

Line 11 of Analysis: Change
CS
= concentration of USP Cisatracurium Besylate RS in the Standard solution

to:
CS
=
concentration of USP Cisatracurium Besylate RS in the Standard solution (mg/mL)

CLARITHROMYCIN TABLETS

IMPURITIES/Organic Impurities/Chromatographic system

USP38–NF33

2850 01-Apr-2015

USP39–NF34

USP39–NF34

Line 1 of Column: Change
4.6-mm × 10-cm; 3-µm packing L1
to:
4.6-mm × 10-cm; 3.5-µm packing L1

Line 1 of Column: Change
4.6-mm × 10-cm; 3-µm packing L1
to:
4.6-mm × 10-cm; 3.5-µm packing L1

COSYNTROPIN

SPECIFIC TESTS/UV Absorption Spectrophotometry

USP38–NF33

2958 01-Apr-2015

USP39–NF34

USP39–NF34

Line 1 of Sample solution: Change
hydrochloride
to:
hydrochloric acid

Line 1 of Sample solution: Change
hydrochloride
to:
hydrochloric acid

COSYNTROPIN

IDENTIFICATION/B. Amino Acid Analysis

USP38–NF33

2958 01-Apr-2015

USP39–NF34

USP39–NF34

Line 8 of Sample hydrolysate preparation: Change
hydrochloride
to:
hydrochloric acid

Line 8 of Sample hydrolysate preparation: Change
hydrochloride
to:
hydrochloric acid

FERRIC AMMONIUM CITRATE

Mercury

Second Supplement to USP37–NF32

ONLINE 01-Apr-2015

USP39–NF34

USP39–NF34

Line 1 of
Procedure: Change
Add 5 mL of stannous chloride solution (1 in 10) to each solution
to:
Add 5 mL of Stannous Chloride Solution to each solution

Line 1 of
Procedure: Change
Add 5 mL of stannous chloride solution (1 in 10) to each solution
to:
Add 5 mL of Stannous Chloride Solution to each solution

MINERAL OIL

SPECIFIC TESTS/Readily Carbonizable Substances Test <271>

Second Supplement to USP37–NF32

ONLINE 01-Apr-2015

USP39–NF34

USP39–NF34

Line 1 of Acceptance criteria: Change
The Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution.
to:
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.

Line 1 of Acceptance criteria: Change
The Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution.
to:
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.

PHENYTOIN SODIUM

USP Reference standards <11>

USP37–NF32

4289 01-Apr-2015

USP39–NF34

USP39–NF34

Line 3 of USP Phenytoin Related Compound A RS: Change

C14H15NO2

to:

C14H13NO2

Line 3 of USP Phenytoin Related Compound A RS: Change

C14H15NO2

to:

C14H13NO2

PURIFIED BENTONITE

IDENTIFICATION/A. X-Ray Diffraction <941>

USP37–NF32

5862 01-Apr-2015

USP39–NF34

USP39–NF34

Line 4 of Acceptance criteria: Change
from the pattern of Sample B is 1.492 and 1.504 Å.

to:
from the pattern of Sample B is between 1.492 and 1.504 Å.

Line 4 of Acceptance criteria: Change
from the pattern of Sample B is 1.492 and 1.504 Å.

to:
from the pattern of Sample B is between 1.492 and 1.504 Å.

QUETIAPINE FUMARATE

IMPURITIES/Organic Impurities

USP38–NF33

5102 01-Apr-2015

USP39–NF34

USP39–NF34

Line 2 of Peak identification solution: Change
USP Quetiapine Fumarate Related Compound B RS

to:
USP Quetiapine Related Compound B RS
AND
Line 3 of Peak identification solution: Change
USP Quetiapine Fumarate Related Compound G RS
to:
USP Quetiapine Related Compound G RS

Line 2 of Peak identification solution: Change
USP Quetiapine Fumarate Related Compound B RS

to:
USP Quetiapine Related Compound B RS
AND
Line 3 of Peak identification solution: Change
USP Quetiapine Fumarate Related Compound G RS
to:
USP Quetiapine Related Compound G RS

QUETIAPINE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 3

USP38–NF33

5104 01-Apr-2015

USP39–NF34

USP39–NF34

Line 7 of Instrumental conditions: Change
10 0mg,
to:
100 mg,
AND
Line 5 of Tolerances: Change
For Tablets labeled to contain 100 mg, 200 mg, 300 mg, or 400 mg:
to:
For Tablets labeled to contain 50 mg, 100 mg, 200 mg, 300 mg, or 400 mg:

Line 7 of Instrumental conditions: Change
10 0mg,
to:
100 mg,
AND
Line 5 of Tolerances: Change
For Tablets labeled to contain 100 mg, 200 mg, 300 mg, or 400 mg:
to:
For Tablets labeled to contain 50 mg, 100 mg, 200 mg, 300 mg, or 400 mg:

RIVASTIGMINE TARTRATE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

First Supplement to USP37–NF32

ONLINE 01-Apr-2015

USP39–NF34

USP39–NF34

Line 2 of USP Rivastigmine Related Compound A RS: Change
Di-p-toluoyl-D-(+)-tartaric acid monohydrate.

C20H20O9 404.37

to:
(+)-Di-(p-toluoyl)-D-tartaric acid.
C20H18O8 386.35

Line 2 of USP Rivastigmine Related Compound A RS: Change
Di-p-toluoyl-D-(+)-tartaric acid monohydrate.

C20H20O9 404.37

to:
(+)-Di-(p-toluoyl)-D-tartaric acid.
C20H18O8 386.35

RIVASTIGMINE TARTRATE CAPSULES

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP37–NF32

4616 01-Apr-2015

USP39–NF34

USP39–NF34

Line 2 of USP Rivastigmine Related Compound A RS: Change
Di-p-toluoyl-D-(+)-tartaric acid monohydrate.

C20H20O9 404.37
to:
(+)-Di-(p-toluoyl)-D-tartaric acid.

C20H18O8 386.35

Line 2 of USP Rivastigmine Related Compound A RS: Change
Di-p-toluoyl-D-(+)-tartaric acid monohydrate.

C20H20O9 404.37
to:
(+)-Di-(p-toluoyl)-D-tartaric acid.

C20H18O8 386.35

SORBITOL SORBITAN SOLUTION

SPECIFIC TESTS

USP37–NF32

6197 01-Apr-2015

USP39–NF34

USP39–NF34

Line 1 of pH <791>: Change
4.0–7.0, in a 14% solution of Sorbitol Sorbitan Solution in carbon dioxide-free water
to:
4.0–7.0, in a 14% (w/w) solution of Sorbitol Sorbitan Solution in carbon dioxide-free water

Line 1 of pH <791>: Change
4.0–7.0, in a 14% solution of Sorbitol Sorbitan Solution in carbon dioxide-free water
to:
4.0–7.0, in a 14% (w/w) solution of Sorbitol Sorbitan Solution in carbon dioxide-free water

TREHALOSE

IMPURITIES/Heavy Metals, Method I <231>

USP37–NF32

6247 01-Apr-2015

USP39–NF34

USP39–NF34

Line 1 of Monitor preparation: Change
Prepare with 2.5 mL of Standard Lead Solution.
to:
Prepare with 2.0 mL of Standard Lead Solution.

Line 1 of Monitor preparation: Change
Prepare with 2.5 mL of Standard Lead Solution.
to:
Prepare with 2.0 mL of Standard Lead Solution.

WITCH HAZEL

Limit of tannins

USP37–NF32

5177 01-Apr-2015

USP39–NF34

USP39–NF34

Line 3 of Chromatographic system: Change
5.0-mm × 15-cm
to:
4.6-mm ×
15-cm

Line 3 of Chromatographic system: Change
5.0-mm × 15-cm
to:
4.6-mm ×
15-cm

AMIODARONE HYDROCHLORIDE

ORGANIC IMPURITIES/Procedure 1/Chromatographic system

USP38–NF33

2198 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Adsorbent: Change
0.5-mm layer of chromatographic silica gel and fluorescent indicator with maximum absorbance at 254 nm
to:
Suitable layer of chromatographic silica gel and fluorescent indicator with maximum absorbance at 254 nm

Line 1 of Adsorbent: Change
0.5-mm layer of chromatographic silica gel and fluorescent indicator with maximum absorbance at 254 nm
to:
Suitable layer of chromatographic silica gel and fluorescent indicator with maximum absorbance at 254 nm

ATROPINE SULFATE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP38–NF33

2325 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 2 of USP Hyoscyamine Related Compound A RS: Change
Norhyoscyamine sulfate; (1R,3r,5S)-8-azabicyclo [3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate.
C16H21NO3 275.34
to:
Norhyoscyamine sulfate;
(1R,3r,5S)-8-Azabicyclo[3.2.1]octan-3-yl (S)-3-hydroxy-2-phenylpropanoate sulfate (2:1).
(C16H21NO3)2 · H2SO4 648.77

Line 2 of USP Hyoscyamine Related Compound A RS: Change
Norhyoscyamine sulfate; (1R,3r,5S)-8-azabicyclo [3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate.
C16H21NO3 275.34
to:
Norhyoscyamine sulfate;
(1R,3r,5S)-8-Azabicyclo[3.2.1]octan-3-yl (S)-3-hydroxy-2-phenylpropanoate sulfate (2:1).
(C16H21NO3)2 · H2SO4 648.77

AZITHROMYCIN

SPECIFIC TESTS/pH <791>

USP37–NF32

1886 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Sample solution: Change
2 mg/mL from the Sample stock solution in a mixture of methanol and water (1:1)
to:
2 mg/mL obtained by mixing equal volumes of Sample stock solution and water

Line 1 of Sample solution: Change
2 mg/mL from the Sample stock solution in a mixture of methanol and water (1:1)
to:
2 mg/mL obtained by mixing equal volumes of Sample stock solution and water

AZITHROMYCIN

IMPURITIES/Organic Impurities/Procedure 1

USP37–NF32

1886 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 6 of Analysis: Change
Calculate the percentages of desosaminylazithromycin and N-demethylazithromycin in the portion of Azithromycin taken:
to:
Calculate the percentages of desosaminylazithromycin, N-demethylazithromycin, and azaerythromycin A in the portion of Azithromycin taken:

Line 6 of Analysis: Change
Calculate the percentages of desosaminylazithromycin and N-demethylazithromycin in the portion of Azithromycin taken:
to:
Calculate the percentages of desosaminylazithromycin, N-demethylazithromycin, and azaerythromycin A in the portion of Azithromycin taken:

BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS

IMPURITIES/Organic Impurities

Revision Bulletin (Official October 01, 2014)

ONLINE 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Row 4 of Column 1 of Table 16: Change
R,S,S,-Thiomorpholine derivativec
to:

S,R,R,-Thiomorpholine derivativec

Row 4 of Column 1 of Table 16: Change
R,S,S,-Thiomorpholine derivativec
to:

S,R,R,-Thiomorpholine derivativec

BUTABARBITAL SODIUM ORAL SOLUTION

ASSAY/Procedure

USP38–NF33

2500 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 17 of Analysis: Change
C

U
= nominal concentration of butabarbital sodium in the Sample solution (µg/mL)
to:
C

U
= nominal concentration of butabarbital sodium in the Sample solution (mg/mL)

Line 17 of Analysis: Change
C

U
= nominal concentration of butabarbital sodium in the Sample solution (µg/mL)
to:
C

U
= nominal concentration of butabarbital sodium in the Sample solution (mg/mL)

BUTABARBITAL SODIUM TABLETS

PERFORMANCE TESTS/Uniformity of Dosage Units <905>/Procedure for content uniformity

USP38–NF33

2501 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 18 of Analysis: Change
C

U
= nominal concentration of butabarbital sodium in the Sample solution
to:
C

U
= nominal concentration of butabarbital sodium in the Sample solution (mg/mL)

Line 18 of Analysis: Change
C

U
= nominal concentration of butabarbital sodium in the Sample solution
to:
C

U
= nominal concentration of butabarbital sodium in the Sample solution (mg/mL)

CAFFEINE CITRATE INJECTION

ASSAY/Procedure

USP38–NF33

2520 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 5 of Analysis: Change
Result = (r

U
/r

S
) × C

S
× (M

r1
/M

r2
) × 100
to:
Result = (r

U
/r

S
) × C

S
× (M

r1
/M

r2
)

Line 5 of Analysis: Change
Result = (r

U
/r

S
) × C

S
× (M

r1
/M

r2
) × 100
to:
Result = (r

U
/r

S
) × C

S
× (M

r1
/M

r2
)

CAFFEINE CITRATE ORAL SOLUTION

ASSAY/Procedure

USP38–NF33

2521 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 5 of Analysis: Change
Result = (r

U
/r

S
) × C

S
× (M

r1
/M

r2
) × 100
to:
Result = (r

U
/r

S
) × C

S
× (M

r1
/M

r2
)

Line 5 of Analysis: Change
Result = (r

U
/r

S
) × C

S
× (M

r1
/M

r2
) × 100
to:
Result = (r

U
/r

S
) × C

S
× (M

r1
/M

r2
)

CHLORAMPHENICOL SODIUM SUCCINATE

Limit of free chloramphenicol

USP37–NF32

2285 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 10 of Chromatographic system: Change
Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not less than 2.0%.
to:
Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.

Line 10 of Chromatographic system: Change
Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not less than 2.0%.
to:
Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS

ASSAY/Procedure

USP38–NF33

2752 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Buffer: Change
0.20 sodium hydroxide
to:
0.20 N sodium hydroxide

Line 1 of Buffer: Change
0.20 sodium hydroxide
to:
0.20 N sodium hydroxide

CIPROFLOXACIN EXTENDED-RELEASE TABLETS

IMPURITIES/Organic Impurities

Revision Bulletin (Official October 01, 2014)

ONLINE 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 16 of Analysis: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND

Line 14 of the second Calculate statement in Analysis: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

Line 16 of Analysis: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND

Read more

CIPROFLOXACIN EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>

Revision Bulletin (Official October 01, 2014)

ONLINE 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 13 of Analysis in Test 1: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81

to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

AND
Line 12 of Analysis in Test 2: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81

to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

AND
Line 13 of Analysis in Test 3: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81

to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

Line 13 of Analysis in Test 1: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81

to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

AND
Line 12 of Analysis in Test 2: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81

Read more

CIPROFLOXACIN EXTENDED-RELEASE TABLETS

ASSAY/Procedure

Revision Bulletin (Official October 01, 2014)

ONLINE 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 17 of Analysis: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

Line 17 of Analysis: Change
M

r2
= molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

CITRIC ACID, MAGNESIUM OXIDE, AND SODIUM CARBONATE IRRIGATION

ASSAY/Citric Acid

USP38–NF33

2844 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 16 of Analysis: Change
C

U
= nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (units/mL)
to:
C

U
= nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (µg/mL)

Line 16 of Analysis: Change
C

U
= nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (units/mL)
to:
C

U
= nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (µg/mL)

ESCITALOPRAM TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 2

USP38–NF33

3364 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 13 of Analysis: Change
M

r2
= molecular weight of escitalopram oxalate, 405.30
to:
M

r2
= molecular weight of escitalopram oxalate, 414.43

Line 13 of Analysis: Change
M

r2
= molecular weight of escitalopram oxalate, 405.30
to:
M

r2
= molecular weight of escitalopram oxalate, 414.43

ESTRADIOL VAGINAL INSERTS

PERFORMANCE TESTS/Dissolution <711>

USP37–NF32

2866 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 3 of Analysis: Change
Calculate the amount of estradiol (C18H24O2) dissolved:
to:
Record the chromatograms, and measure the responses for the estradiol peak. Construct a calibration curve by plotting the peak response versus concentration of the Standard solutions. Determine the amount of estradiol (C18H24O2) in the Sample solutions from a linear regression analysis of the calibration curve.

Calculate the amount of estradiol (C18H24O2) dissolved:

Line 3 of Analysis: Change
Calculate the amount of estradiol (C18H24O2) dissolved:
to:
Record the chromatograms, and measure the responses for the estradiol peak. Construct a calibration curve by plotting the peak response versus concentration of the Standard solutions. Determine the amount of estradiol (C18H24O2) in the Sample solutions from a linear regression analysis of the calibration curve.

Read more

EXTENDED PHENYTOIN SODIUM CAPSULES

IDENTIFICATION/A. Infrared Absorption—General <197>

First Supplement to USP37–NF32

6681 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Sample: Change
6 mg/mL of phenytoin sodium in water from a suitable number of Capsules prepared as follows. Nominally transfer 300 mg of the powder into 50 mL of water in a separator.
to:
300 mg of phenytoin sodium from the contents of Capsules in 50 mL of water in a separator.

Line 1 of Sample: Change
6 mg/mL of phenytoin sodium in water from a suitable number of Capsules prepared as follows. Nominally transfer 300 mg of the powder into 50 mL of water in a separator.
to:
300 mg of phenytoin sodium from the contents of Capsules in 50 mL of water in a separator.

GADOVERSETAMIDE INJECTION

Relaxivity <761>

USP37–NF32

3121 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Apparatus: Change
Use a mini-NMR spectrometer with suitable sensitivity (see Apparatus under Nuclear Magnetic Resonance <761>).

to:
Use an NMR spectrometer with suitable sensitivity.

Line 1 of Apparatus: Change
Use a mini-NMR spectrometer with suitable sensitivity (see Apparatus under Nuclear Magnetic Resonance <761>).

to:
Use an NMR spectrometer with suitable sensitivity.

GLYCERYL BEHENATE

ASSAY/Procedure/Chromatographic system

Second Supplement to USP37–NF32

7075 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Column: Change
7.0-mm × 60-cm; 5-µm packing L21
[Note—Two 7.0-mm × 30-cm L21 columns
to:
7.5-mm × 60-cm; 5-µm 100-Å packing L21
[Note—Two 7.5-mm × 30-cm L21 columns

Line 1 of Column: Change
7.0-mm × 60-cm; 5-µm packing L21
[Note—Two 7.0-mm × 30-cm L21 columns
to:
7.5-mm × 60-cm; 5-µm 100-Å packing L21
[Note—Two 7.5-mm × 30-cm L21 columns

HYDROGEN PEROXIDE CONCENTRATE

ASSAY/Procedure

USP37–NF32

3272 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Sample solution: Change
1 mL of Concentrate, diluted to 100 mL
to:
Weigh about 1 mL of Concentrate in a 100-mL volumetric flask, and dilute with water to volume.

Line 1 of Sample solution: Change
1 mL of Concentrate, diluted to 100 mL
to:
Weigh about 1 mL of Concentrate in a 100-mL volumetric flask, and dilute with water to volume.

HYOSCYAMINE SULFATE

USP Reference standards <11>

USP37–NF32

3293 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 2 of USP Hyoscyamine Related Compound A RS: Change
(1R,3R,5S)-8-azabicyclo[3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate.
to:
(1R,3r,5S)-8-Azabicyclo[3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate sulfate (2:1).

Line 2 of USP Hyoscyamine Related Compound A RS: Change
(1R,3R,5S)-8-azabicyclo[3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate.
to:
(1R,3r,5S)-8-Azabicyclo[3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate sulfate (2:1).

MESALAMINE RECTAL SUSPENSION

OTHER COMPONENTS/Content of Sodium Benzoate (if present)

USP38–NF33

4270 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 5 of Analysis: Change
Result = (rU
/rS
) × CS
× (10/W) × 100
to:
Result = (rU/rS
) × CS
× (10/W)

Line 5 of Analysis: Change
Result = (rU
/rS
) × CS
× (10/W) × 100
to:
Result = (rU/rS
) × CS
× (10/W)

METHOTREXATE

IMPURITIES/Organic Impurities/Procedure 1: Related Compounds

USP37–NF32

3762 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Standard solution A: Change
0.1 μg/mL of USP Methotrexate RS in Solution A, from the Standard stock solution

to:
0.1 µg/mL of USP Methotrexate RS in Solution A, from Standard stock solution A

Line 1 of Standard solution A: Change
0.1 μg/mL of USP Methotrexate RS in Solution A, from the Standard stock solution

to:
0.1 µg/mL of USP Methotrexate RS in Solution A, from Standard stock solution A

PACLITAXEL

Related compounds/Test 2 (for Material Labeled as Produced by a Semisynthetic Process)

USP37–NF32

4163 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 6 after table in Chromatographic system: Change
the relative standard deviation for replicate injections is not more than 2.0%.
to:
the relative standard deviation for replicate injections is not more than 2.0% for the paclitaxel peak.

Line 6 after table in Chromatographic system: Change
the relative standard deviation for replicate injections is not more than 2.0%.
to:
the relative standard deviation for replicate injections is not more than 2.0% for the paclitaxel peak.

PANCURONIUM BROMIDE

ASSAY/Procedure/Chromatographic system

USP37–NF32

4176 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Column: Change
4.6-mm × 250-cm; 5-µm packing L1
to:
4.6-mm × 25-cm; 5-µm packing L1

Line 1 of Column: Change
4.6-mm × 250-cm; 5-µm packing L1
to:
4.6-mm × 25-cm; 5-µm packing L1

PAROXETINE HYDROCHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP38–NF33

4765 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Lines 4 and 7 of USP Paroxetine System Suitability Mixture A RS: Change
hydrochloride (3 S-trans)
to:
hydrochloride (3S-trans)

Lines 4 and 7 of USP Paroxetine System Suitability Mixture A RS: Change
hydrochloride (3 S-trans)
to:
hydrochloride (3S-trans)

PAROXETINE HYDROCHLORIDE

IMPURITIES/Limit of 1-Methyl-4-(p-fluorophenyl)-1,2,3,6-tetrahydropyridine

USP38–NF33

4765 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Line 1 of Standard solution: Change
42 mg/mL

to:
42 ng/mL

Line 1 of Standard solution: Change
42 mg/mL

to:
42 ng/mL

POTASSIUM BITARTRATE

IDENTIFICATION

USP37–NF32

4346 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Change
C. Identification Tests—General, Tartrate <191>


to:
C. Identification Tests—General, Tartrate <191>: Meets the requirements

AND
Delete subsections:
Sample solution: 1 in 10 solution

Acceptance criteria: Meets the requirements

Change
C. Identification Tests—General, Tartrate <191>

to:
C. Identification Tests—General, Tartrate <191>: Meets the requirements

AND
Delete subsections:
Sample solution: 1 in 10 solution

Acceptance criteria: Meets the requirements

POTASSIUM SODIUM TARTRATE

Identification/C:

USP37–NF32

4369 01-Feb-2015

USP39–NF34

Second Supplement to USP38–NF33

Change
A solution (1 in 10) responds to the tests for Tartrate <191>.
to:
Responds to the tests for Tartrate <191>.

Change
A solution (1 in 10) responds to the tests for Tartrate <191>.
to:
Responds to the tests for Tartrate <191>.

XLS CSV