How to Use the USP–NF Errata Table

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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
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

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

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

to:
M

r2
= molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

AND
Line 13 of Analysis in Test 3

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.

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>.

RED CLOVER TABLETS SPECIFIC TESTS/Microbial Enumeration Tests <2021> USP37–NF32 5526 01-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33
Line 4: Change
NLT 103 cfu/g.
to:
NMT 103 cfu/g.


Line 4: Change
NLT 103 cfu/g.

to:
NMT 103 cfu/g.

RISPERIDONE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP37–NF32 7240 01-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33
Line 2 of USP Risperidone Related Compound G RS: Change
3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
C23H28FN3O3 413.49
to:
3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one hydrochloride.
C23H28FN3O3·HCl 448.94




Line 2 of USP Risperidone Related Compound G RS: Change

3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.

C23H28FN3O3 413.49
to:

3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one hydrochloride.

C23H28FN3O3·HCl 448.94

TERAZOSIN TABLETS PERFORMANCE TESTS/Dissolution <711> USP37–NF32 4874 01-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33
Line 10 of Analysis: Change
Mr2 = molecular weight of terazosin hydrochloride dihydrate, 459.92
to:
Mr2 = molecular weight of terazosin hydrochloride, 423.89


Line 10 of Analysis: Change
Mr2 = molecular weight of terazosin hydrochloride dihydrate, 459.92
to:
Mr2 = molecular weight of terazosin hydrochloride, 423.89

TETRACAINE OINTMENT Assay USP37–NF32 4891 01-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33
Line 7 of Procedure: Change
(264.37/300.83)(C)(AU / AS )
to:
(264.36/300.82)(C)(AU / AS )


Line 7 of Procedure: Change
(264.37/300.83)(C)(AU
/ AS
)
to:
(264.36/300.82)(C)(AU
/ AS
)

VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official April 01, 2014) ONLINE 01-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33
Line 2 of USP Valsartan Related Compound B RS: Change
(S-N-Butyryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine.
to:
N-Butyryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-L-valine.


Line 2 of USP Valsartan Related Compound B RS: Change
(S-N-Butyryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine.

to:
N-Butyryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-L-valine.

VALSARTAN TABLETS PERFORMANCE TESTS/Dissolution <711> USP37–NF32 5116 01-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Medium: Change
pH 6.8 phosphate buffer; 1000 mL, degassed
to:
pH 6.8 phosphate buffer prepared as follows. Dissolve 6.805 g of monobasic potassium phosphate and 0.896 g of sodium hydroxide in and dilute with water to 1000 mL. Adjust with 0.2 M sodium hydroxide or 1 M phosphoric acid as required to a pH of 6.8; 1000 mL degassed.


Line 1 of Medium: Change
pH 6.8 phosphate buffer; 1000 mL, degassed

to:
pH 6.8 phosphate buffer prepared as follows. Dissolve 6.805 g of monobasic potassium phosphate and 0.896 g of sodium hydroxide in and dilute with water to 1000 mL. Adjust with 0.2 M sodium hydroxide or 1 M phosphoric acid as required to a pH of 6.8; 1000 mL degassed.

ZIPRASIDONE HYDROCHLORIDE IMPURITIES/Limit of Tetrahydrofuran USP37–NF32 5219 01-Feb-2015 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Standard solution: Change
0.05 mg/mL of USP Ziprasidone Hydrochloride RS in dimethyl sulfoxide
to:
0.05 mg/mL of tetrahydrofuran in dimethyl sulfoxide


Line 1 of Standard solution: Change
0.05 mg/mL of USP Ziprasidone Hydrochloride RS in dimethyl sulfoxide
to:
0.05 mg/mL of tetrahydrofuran in dimethyl sulfoxide

<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability USP37–NF32 1301 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 11 of Method 2—Multichannel Instruments: Change
NMT ±10% of stated size.
to:
NMT ±10% of stated concentration.


Line 11 of Method 2—Multichannel Instruments: Change
NMT ±10% of stated size.
to:
NMT ±10% of stated concentration.

<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS USP37–NF32 315 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change
A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
to:
A single-unit package for an article intended for parenteral administration. A single-dose container is labeled as such. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.


Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change
A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
to:
A single-unit package for an article intended for parenteral administration. A single-dose container is labeled as such.

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CEFADROXIL FOR ORAL SUSPENSION IDENTIFICATION/Thin-Layer Chromatography/Chromatographic system USP37–NF32 2182 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 2 of Developing solvent system: Change
(60:40:15)
to:
(60: 40: 1.5)


Line 2 of Developing solvent system: Change
(60:40:15)
to:
(60: 40: 1.5)

CEFUROXIME AXETIL FOR ORAL SUSPENSION ASSAY/Procedure USP37–NF32 2243 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Change
Buffer: 23 mg/mL of monobasic ammonium phosphate in water
to:
Solution A: 23 g/L of monobasic ammonium phosphate in water
AND
Line 4 of System suitability solution: Change
Dilute with Buffer to volume.
to:
Dilute with Solution A to volume.
AND
Line 3 of Standard solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.
AND
Line 3 of Sample solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.

















Change
Buffer: 23 mg/mL of monobasic ammonium phosphate in water

to:
Solution A: 23 g/L of monobasic ammonium phosphate in water
AND
Line 4 of System suitability solution: Change
Dilute with Buffer to volume.
to:
Dilute with Solution A to volume.
AND
Line 3 of Standard solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.
AND
Line 3 of Sample solution: Change
and dilute with Buffer to volume.
to:
and dilute w

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CHLORPHENIRAMINE MALEATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP37–NF32 6617 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Sample: Change
100 mg/mL in water
to:
100 mg/mL in water at 20°


Line 1 of Sample: Change
100 mg/mL in water
to:
100 mg/mL in water at 20°

COPOVIDONE IMPURITIES/Limit of Monomers (1-Vinyl-2-Pyrrolidone, Vinyl Acetate, and 2-Pyrrolidone) USP37–NF32 5938 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 29 of Analysis: Change
Calculate the content of 2-pyrrolidinone
to:
Calculate the content of 2-pyrrolidone


Line 29 of Analysis: Change
Calculate the content of 2-pyrrolidinone
to:
Calculate the content of 2-pyrrolidone

DOLASETRON MESYLATE CHEMICAL INFORMATION USP37–NF32 2693 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 7: Change
[115956-13-3].
to:
[878143-33-0]
Anhydrous [115956-13-3].



Line 7: Change
[115956-13-3].

to:
[878143-33-0]
Anhydrous [115956-13-3].

ERYTHROMYCIN DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Buffer stage First Supplement to USP37–NF32 6633 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Standard solution: Change
0.28 mg/mL of USP Erythromycin RS in Medium
to:
Dissolve USP Erythromycin RS in Medium to obtain a concentration similar to that of the Sample solution.
AND
Line 1 of Sample solution: Change
Pass portions of the solution under test through a suitable filter.
to:
If necessary, dilute a filtered portion of the solution under test with Medium to obtain a solution containing about 0.28 mg/mL of erythromycin.







Line 1 of Standard solution: Change
0.28 mg/mL of USP Erythromycin RS in Medium

to:
Dissolve USP Erythromycin RS in Medium to obtain a concentration similar to that of the Sample solution.
AND
Line 1 of Sample solution: Change
Pass portions of the solution under test through a suitable filter.
to:
If necessary, dilute a filtered portion of the solution under test with Medium to obtain a solution containing about 0.28 mg/mL of erythromycin.

FENTANYL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP37–NF32 ONLINE 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Delete
USP Fentanyl Related Compound C RS
AND
Delete
USP Fentanyl Related Compound F RS



Delete
USP Fentanyl Related Compound C RS
AND
Delete
USP Fentanyl Related Compound F RS

FLUDARABINE PHOSPHATE IMPURITIES/Limit of Sodium USP37–NF32 3003 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Standard solution: Change
1 µg/mL of sodium chloride in water
to:
1 µg/mL of sodium in water


Line 1 of Standard solution: Change
1 µg/mL of sodium chloride in water
to:
1 µg/mL of sodium in water

FLUTAMIDE ASSAY/Procedure USP37–NF32 3057 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 2 of Sample solution: Change
Dissolve the sample in acetonitrile
to:
Dissolve a previously dried sample in acetonitrile


Line 2 of Sample solution: Change
Dissolve the sample in acetonitrile
to:
Dissolve a previously dried sample in acetonitrile

GANODERMA LUCIDUM FRUITING BODY SPECIFIC TESTS/Botanical Characteristics Revision Bulletin (Official August 01, 2014) ONLINE 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 6 of Macroscopic: Change
concentrically culcate
to:
concentrically sulcate


Line 6 of Macroscopic: Change
concentrically culcate
to:
concentrically sulcate

GANODERMA LUCIDUM FRUITING BODY COMPOSITION/Content of Triterpenoic Acids Revision Bulletin (Official August 01, 2014) ONLINE 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
r S = peak area of ganoderic acid in Standard solution A
to:
r S = peak area of ganoderic acid A in Standard solution A
AND
Line 10 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response factor, with respect to ganoderic acid A (see Table 2)












Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND

Line 3 of variable definition list in Analysis: Change
r

S
= peak area of ganoderic acid in Standard solution A

to:
r

S
= peak area of ganoderic acid A in Standard solution A

AND
Line 10 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response f

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XLS CSV