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

<1663> EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING SYSTEMS

REFERENCES

USP39–NF34

1835 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Delete references 5, 7, 9, and 12.

Delete references 5, 7, 9, and 12.

<1664> ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS

REFERENCES

USP39–NF34

1850 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Delete reference 8.

Delete reference 8.

<1664.1> ORALLY INHALED AND NASAL DRUG PRODUCTS

REFERENCES

USP39–NF34

1862 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Delete reference 3.

Delete reference 3.

BANABA LEAF DRY EXTRACT

IDENTIFICATION

USP39–NF34

6494 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Delete Identification A.
AND
Line 1 of Identification B: Change
B.
to:
A.
AND
Line 1 of Identification C: Change
C.
to:
B.









Delete Identification A.
AND
Line 1 of Identification B: Change
B.
to:
A.
AND
Line 1 of Identification C: Change
C.
to:
B.

BISOCTRIZOLE

IMPURITIES/Organic Impurities

First Supplement to USP39–NF34

8008 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Footnote b of Table 2: Change
Phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].
to:
Phenol, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].


Footnote b of Table 2: Change
Phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].
to:
Phenol, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].

BISOCTRIZOLE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

First Supplement to USP39–NF34

8008 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Bisoctrizole Resolution Mixture RS: Change
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.
to:
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.


Line 2 of USP Bisoctrizole Resolution Mixture RS: Change
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.
to:
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.

FELBAMATE ORAL SUSPENSION

PERFORMANCE TESTS/Dissolution <711>

USP39–NF34

3855 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 4 of System suitability: Change
[Note—The relative retention times for methylparaben and felbamate are about 0.5 and 1.0, respectively.]
to:
[Note—The relative retention times for felbamate and methylparaben are about 1.0 and 1.5, respectively.]


Line 4 of System suitability: Change
[Note—The relative retention times for methylparaben and felbamate are about 0.5 and 1.0, respectively.]
to:
[Note—The relative retention times for felbamate and methylparaben are about 1.0 and 1.5, respectively.]

FEXOFENADINE HYDROCHLORIDE

CHEMICAL INFORMATION

USP39–NF34

3895 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 7: Change
[138452-21-8].
to:
[153439-40-8].


Line 7: Change
[138452-21-8].
to:
[153439-40-8].

FLUORESCEIN SODIUM

IMPURITIES/Organic Impurities

USP39–NF34

3960 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Row 7 of column 1 of Table 2: Change
Total impurities
to:
Total unspecified impurities


Row 7 of column 1 of Table 2: Change
Total impurities
to:
Total unspecified impurities

FUMARIC ACID

SPECIFIC TESTS/Water Determination, Method I <921>

USP39–NF34

7309 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1: Change
0.5%
to:
NMT 0.5%


Line 1: Change
0.5%
to:
NMT 0.5%

GRANISETRON HYDROCHLORIDE

USP Reference standards <11>

USP39–NF34

4151 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
(N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
AND
Line 2 of USP Granisetron Related Compound E RS: Change
((1R,3rS,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt).
to:
((1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt).







Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
(N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
AND
Line 2 of USP Granisetron Related Compound E RS: Change
((1R,3rS,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt).

Read more

GRANISETRON HYDROCHLORIDE INJECTION

USP Reference standards <11>

USP39–NF34

4153 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide.


Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide.

GRANISETRON HYDROCHLORIDE TABLETS

USP Reference standards <11>

USP39–NF34

4155 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide.


Line 2 of USP Granisetron Related Compound B RS: Change
(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).
to:
N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide.

HALCINONIDE CREAM

IMPURITIES/Organic Impurities/Chromatographic system

USP39–NF34

4176 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of Column: Change
1.8-µm packing L1
to:
1.7-µm packing L1


Line 1 of Column: Change
1.8-µm packing L1
to:
1.7-µm packing L1

HALOPERIDOL DECANOATE

IMPURITIES/Organic Impurities/Table 2

USP39–NF34

4184 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Footnote k: Change
4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
to:
4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
AND
Footnote l: Change
4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
to:
4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.







Footnote k: Change
4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
to:
4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
AND
Footnote l: Change
4-(3′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.
to:
4-(4′-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.

KETOROLAC TROMETHAMINE INJECTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4468 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 4 of USP Ketorolac Related Compound A RS: Change
358.15
to:
358.39
AND
Line 3 of USP Ketorolac Related Compound B RS: Change
227.09
to:
227.26
AND
Line 3 of USP Ketorolac Related Compound C RS: Change
225.09
to:
225.24
AND
Line 3 of USP Ketorolac Related Compound D: Change
211.1
to:
211.3

















Line 4 of USP Ketorolac Related Compound A RS: Change
358.15
to:
358.39
AND
Line 3 of USP Ketorolac Related Compound B RS: Change
227.09
to:
227.26
AND
Line 3 of USP Ketorolac Related Compound C RS: Change
225.09
to:
225.24
AND
Line 3 of USP Ketorolac Related Compound D: Change
211.1
to:
211.3

LOVASTATIN

USP Reference standards <11>

USP39–NF34

4631 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 2 of USP Lovastatin Related Compound A RS: Change
[Dihydro-lovastatin][butanoic acid, 2-methyl-, 1,2,3,4,4a,7,8,8a-octahydro-3,7-dimethyl-8-[2(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α(R*),3α,7β,8β(2S*,4S*),-8αβ]]]-.
to:
(1S,3S,4aR,7S,8S,8aS)-8-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-3,7-dimethyl-1,2,3,4,4a,7,8,8a-octahydronaphthalen-1-yl (S)-2-methylbutanoate.


Line 2 of USP Lovastatin Related Compound A RS: Change
[Dihydro-lovastatin][butanoic acid, 2-methyl-, 1,2,3,4,4a,7,8,8a-octahydro-3,7-dimethyl-8-[2(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α(R*),3α,7β,8β(2S*,4S*),-8αβ]]]-.
to:
(1S,3S,4aR,7S,8S,8aS)-8-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-3,7-dimethyl-1,2,3,4,4a,7,8,8a-octahydronaphthalen-1-yl (S)-2-methylbutanoate.

NAPROXEN SODIUM TABLETS

IMPURITIES/Organic Impurities

Second Supplement to USP39–NF34

ONLINE 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 6 of Analysis: Change
Result = (rU/rS) × (CU/CS) × 100
to:
Result = (rU/rS) × (CS/CU) × 100


Line 6 of Analysis: Change
Result = (rU/rS) × (CU/CS) × 100
to:
Result = (rU/rS) × (CS/CU) × 100

NAPROXEN TABLETS

ASSAY/Procedure/System suitability/Suitability requirements

USP39–NF34

4993 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of Tailing factor: Change
NLT 2.0
to:
NMT 2.0


Line 1 of Tailing factor: Change
NLT 2.0
to:
NMT 2.0

NAPROXEN TABLETS

IMPURITIES/Organic Impurities

USP39–NF34

4993 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 6 of Analysis: Change
Result = (rU/rS) × (CU/CS) × 100
to:
Result = (rU/rS) × (CS/CU) × 100


Line 6 of Analysis: Change
Result = (rU/rS) × (CU/CS) × 100
to:
Result = (rU/rS) × (CS/CU) × 100

OMEGA-3-ACID ETHYL ESTERS CAPSULES

ASSAY/Content of EPAee, DHAee, and Total Omega-3-Acid Ethyl Esters/Analysis

Second Supplement to USP39–NF34

8755 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 16 of the third equation: Change
L = label claim of total omega-3-acids ethyl esters (g/Capsule)
to:
L = label claim of total omega-3-acids ethyl esters (mg/Capsule)


Line 16 of the third equation: Change
L = label claim of total omega-3-acids ethyl esters (g/Capsule)
to:
L = label claim of total omega-3-acids ethyl esters (mg/Capsule)

RIZATRIPTAN BENZOATE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Chromatographic procedure

USP39–NF34

5750 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Add
Buffer: 1.36 g/L of monobasic potassium phosphate. Adjust the pH of the solution with phosphoric acid to 2.5.

Add
Buffer: 1.36 g/L of monobasic potassium phosphate. Adjust the pH of the solution with phosphoric acid to 2.5.

SIMETHICONE

ASSAY/Procedure/Analysis

USP39–NF34

5843 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of Samples: Change
Standard stock solution, Standard solution, Sample stock solution, and Sample solution
to:
Standard solution and Sample solution


Line 1 of Samples: Change
Standard stock solution, Standard solution, Sample stock solution, and Sample solution
to:
Standard solution and Sample solution

SIMVASTATIN TABLETS

IMPURITIES/Organic Impurities/Analysis

USP39–NF34

5848 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 5: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × (CS/CU)× 100
AND
Delete the variable definitions for Mr1 and Mr2.




Line 5: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × (CS/CU)× 100
AND
Delete the variable definitions for Mr1 and Mr2.

SODIUM NITROPRUSSIDE

Identification

USP39–NF34

5880 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of Identification C: Change
A solution (1 in 4) responds to the flame test for Sodium <191>.
to:
A solution (1 in 4) imparts an intense yellow color to a nonluminous flame.


Line 1 of Identification C: Change
A solution (1 in 4) responds to the flame test for Sodium <191>.
to:
A solution (1 in 4) imparts an intense yellow color to a nonluminous flame.

SULINDAC TABLETS

IMPURITIES/Organic Impurities

First Supplement to USP39–NF34

8160 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of System suitability/Relative standard deviation: Change
NMT 2.0% for any peak
to:
NMT 2.0% for sulindac, sulindac related compound B, and sulindac related compound C
AND
Line 3 of Analysis: Change
Calculate the percentage of the labeled amount of sulindac related compound A, sulindac related compound B, or sulindac related compound C in the portion of Tablets taken:
to:
Calculate the percentage of sulindac related compound B or sulindac related compound C in the portion of Tablets taken:
AND
Line 8 of Analysis: Change
rU = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Sample solution
to:
rU = peak response of sulindac related compound B or sulindac related compound C from the Sample solution
AND
Line 12 of Analysis: Change
rS = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Standard solution
to:
rS = peak response of sulindac related compound B or sulindac related compound C from the Standard solution

















Line 1 of System suitability/Relative standard deviation: Change
NMT 2.0% for any peak
to:
NMT 2.0% for sulindac, sulindac related compound B, and sulindac related compound C
AND
Line 3 of Analysis: Change
Calculate the percentage of the labeled amount of sulindac related compound A, sulindac related compound B, or sulindac related compound C in the portion of Tablets taken:
to:
Calculate the percentage of sulindac related compound B or sulindac related compound C in the portion of Tablets taken:
AND
Line 8 of Analysis: Change

Read more

TRIHEXYPHENIDYL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES

Assay

USP39–NF34

6265 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of Mobile phase and Chromatographic system: Change
Prepare as directed in the Assay under Trihexyphenidyl Hydrochloride.
to:
Mobile phase—Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 8-cm column that contains 3-µm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency determined from the analyte peak is not less than 1300 theoretical plates, the tailing factor for the analyte peak is not more than 3.0, and the relative standard deviation for replicate injections is not more than 1.0%.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Trihexyphenidyl Hydrochloride.
to:
Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
AND
Line 6 of Procedure: Change
and the other terms are as defined therein.
to:
C is the concentration, in mg per mL, of USP Trihexyphenidyl Hydrochloride RS in the Standard preparation, rU and rS are the trihexyphenidyl peak responses obtained from the Assay preparation and the Standard preparation, respectively.













Line 1 of Mobile phase and Chromatographic system: Change
Prepare as directed in the Assay under Trihexyphenidyl Hydrochloride.
to:
Mobile phase—Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and degas.

Read more

TRIHEXYPHENIDYL HYDROCHLORIDE ORAL SOLUTION

Assay

USP39–NF34

6266 01-Aug-2016

USP41–NF36

First Supplement to USP40–NF35

Line 1 of Mobile phase and Chromatographic system: Change
Prepare as directed in the Assay under TrihexyphenidylHydrochloride.
to:
Mobile phase—Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 8-cm column that contains 3-µm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency determined from the analyte peak is not less than 1300 theoretical plates, the tailing factor for the analyte peak is not more than 3.0, and the relative standard deviation for replicate injections is not more than 1.0%.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Trihexyphenidyl Hydrochloride.
to:
Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
AND
Line 7 of Procedure: Change
and the other terms are as defined therein.
to:
C is the concentration, in mg per mL, of USP Trihexyphenidyl Hydrochloride RS in the Standard preparation, rU and rS are the trihexyphenidyl peak responses obtained from the Assay preparation and the Standard preparation, respectively.













Line 1 of Mobile phase and Chromatographic system: Change
Prepare as directed in the Assay under TrihexyphenidylHydrochloride.
to:
Mobile phase—Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and degas.

Read more

<1724> SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS

IN VITRO PERFORMANCE TESTS

USP39–NF34

1869 01-Jun-2016

USP40–NF35

USP40–NF35

Line 7 of Application of Drug Release: Change
The individual amounts of drug released from R is plotted versus time,
to:
The individual amounts of drug released from R are plotted versus the square root of time,


Line 7 of Application of Drug Release: Change
The individual amounts of drug released from R is plotted versus time,
to:
The individual amounts of drug released from R are plotted versus the square root of time,

<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS

5. FACILITIES AND ENGINEERING CONTROLS/5.3 Compounding

First Supplement to USP39–NF34

7721 01-Jun-2016

USP40–NF35

USP40–NF35

First bullet in second paragraph: Change
• Be externally vented through high-efficiency particulate air (HEPA) filtration
to:
• Be externally vented


First bullet in second paragraph: Change
• Be externally vented through high-efficiency particulate air (HEPA) filtration
to:
• Be externally vented

ALPRAZOLAM EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>

USP39–NF34

2389 01-Jun-2016

USP40–NF35

USP40–NF35

Variable definition list of second equation in Test 2/Analysis: Change
VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
VS = volume of the Sample solution withdrawn at each time point (mL)
AND
Variable definition list of second equation in Test 3/Analysis: Change
VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
VS = volume of the Sample solution withdrawn at each time point (mL)







Variable definition list of second equation in Test 2/Analysis: Change
VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
VS = volume of the Sample solution withdrawn at each time point (mL)
AND
Variable definition list of second equation in Test 3/Analysis: Change
VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
VS = volume of the

Read more

BACITRACIN ZINC

IMPURITIES

USP39–NF34

2674 01-Jun-2016

USP40–NF35

USP40–NF35

Delete the Residue on Ignition <281> test.

Delete the Residue on Ignition <281> test.

CETYL ALCOHOL

IMPURITIES/Limit of Related Fatty Alcohols

USP39–NF34

7239 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Sample solution: Change
1 mg/mL of Cetyl Alcohol in ethanol
to:
Prepare 1.0 mg/mL of Cetyl Alcohol in ethanol, and heat the solution in a sealed container in a 50° water bath until cetyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.


Line 1 of Sample solution: Change
1 mg/mL of Cetyl Alcohol in ethanol
to:
Prepare 1.0 mg/mL of Cetyl Alcohol in ethanol, and heat the solution in a sealed container in a 50° water bath until cetyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.

CHONDROITIN SULFATE SODIUM, SHARK

IMPURITIES/Limit of Protein

USP39–NF34

6570 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of Instrumental conditions: Change
(See Spectrophotometry and Light-Scattering <851>.)
to:
(See Ultraviolet-Visible Spectroscopy <857>.)


Line 2 of Instrumental conditions: Change
(See Spectrophotometry and Light-Scattering <851>.)
to:
(See Ultraviolet-Visible Spectroscopy <857>.)

CHONDROITIN SULFATE SODIUM, SHARK

COMPOSITION/Disaccharide Composition

USP39–NF34

6570 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of Chondroitinase ABC solution: Change
10.0 mL of Buffer solution
to:
1.0 mL of Buffer solution
AND
Line 4 of Analysis: Change
and 1.0 mL
to:
and 0.1 mL







Line 2 of Chondroitinase ABC solution: Change
10.0 mL of Buffer solution
to:
1.0 mL of Buffer solution
AND
Line 4 of Analysis: Change
and 1.0 mL
to:
and 0.1 mL

CHONDROITIN SULFATE SODIUM, SHARK

SPECIFIC TESTS/Clarity and Color of Solution

USP39–NF34

6570 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of Instrumental conditions: Change
(See Spectrophotometry and Light-Scattering <851>.)
to:
(See Ultraviolet-Visible Spectroscopy <857>.)


Line 2 of Instrumental conditions: Change
(See Spectrophotometry and Light-Scattering <851>.)
to:
(See Ultraviolet-Visible Spectroscopy <857>.)

DIAZEPAM INJECTION

Assay

USP39–NF34

3445 01-Jun-2016

USP40–NF35

USP40–NF35

Line 7 of Procedure:
50C / V(RU / RS)
to:
50(C / V)(RU / RS)


Line 7 of Procedure:
50C / V(RU / RS)
to:
50(C / V)(RU / RS)

DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS

IMPURITIES/Organic Impurities

USP39–NF34

3460 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Standard solution: Change
0.001 mg/mL of USP Diclofenac Sodium RS in Diluent
to:
0.001 mg/mL each of USP Diclofenac Sodium RS and USP Diclofenac Related Compound A RS in Diluent


Line 1 of Standard solution: Change
0.001 mg/mL of USP Diclofenac Sodium RS in Diluent
to:
0.001 mg/mL each of USP Diclofenac Sodium RS and USP Diclofenac Related Compound A RS in Diluent

IMIQUIMOD CREAM

IMPURITIES/Organic Impurities

USP39–NF34

4289 01-Jun-2016

USP40–NF35

USP40–NF35

Row 2 of Column 3 of Table 2: Change
1.5
to:
1.15
AND
Row 3 of Column 3 of Table 2: Change
1.15
to:
1.5







Row 2 of Column 3 of Table 2: Change
1.5
to:
1.15
AND
Row 3 of Column 3 of Table 2: Change
1.15
to:
1.5

LORAZEPAM

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4618 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of USP Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO


Line 3 of USP Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO

LORAZEPAM INJECTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4620 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO


Line 3 of Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO

LORAZEPAM ORAL CONCENTRATE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4621 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO


Line 3 of Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO

LORAZEPAM TABLETS

ADDITIONAL REQUIREMENTS/USP Reference Standards RS <11>

USP39–NF34

4622 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of USP Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO


Line 3 of USP Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO

METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>

USP39–NF34

4766 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Test 3: Change
Medium, Apparatus 1, Apparatus 2, and Analysis:
to:
Medium, Apparatus 1, and Apparatus 2:


Line 3 of Test 3: Change
Medium, Apparatus 1, Apparatus 2, and Analysis:
to:
Medium, Apparatus 1, and Apparatus 2:

MYCOPHENOLATE SODIUM

ASSAY/Procedure

USP39–NF34

4965 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3: Change
Solvent A
to:
Solution A
AND
Line 5: Change
Solvent B
to:
Solution B







Line 3: Change
Solvent A
to:
Solution A
AND
Line 5: Change
Solvent B
to:
Solution B

MYRISTYL ALCOHOL

ASSAY/Procedure

USP39–NF34

7413 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Myristyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of Myristyl Alcohol in Internal standard solution







Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved.

Read more

NALTREXONE HYDROCHLORIDE

Related compounds

USP39–NF34

4985 01-Jun-2016

USP40–NF35

USP40–NF35

Line 5: Change
10F(C/W)(rU / rS)
to:
1000F(C/W)(rU/rS)


Line 5: Change
10F(C/W)(rU / rS)
to:
1000F(C/W)(rU/rS)

NICOTINE POLACRILEX

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

5061 01-Jun-2016

USP40–NF35

USP40–NF35

Add
USP Polacrilex Resin RS

Add
USP Polacrilex Resin RS

OLEYL ALCOHOL

ASSAY/Procedure

USP39–NF34

7424 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Oleyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of Oleyl Alcohol in Internal standard solution







Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Oleyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved.

Read more

OXANDROLONE TABLETS

Dissolution <711>/Test 3

USP39–NF34

5193 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Chromatographic system: Change
30-cm column
to:
3-cm column


Line 3 of Chromatographic system: Change
30-cm column
to:
3-cm column

XLS CSV