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

<1132> RESIDUAL HOST CELL PROTEIN MEASUREMENT IN BIOPHARMACEUTICALS

4. HCP IMMUNOASSAY METHOD VALIDATION/4.3 Sample Linearity/Table 4

Second Supplement to USP38–NF33

7647 01-Apr-2016

USP40–NF35

USP40–NF35

Product column: Change
10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16
to:
10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625
AND
Sample 1/HCP ratio column: Change
4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6
to:
4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6
AND
Sample 2/HCP ratio column: Change
2.0, 3.3, 4.0, 5.9, 5.3, 6.1, <6
to:
2.00, 3.30, 4.00, 5.92, 5.28, 6.08, <6
AND
Sample 3/HCP ratio column: Change
0.3, 0.5, 0.6, 0.9, 1.4, <6, <6
to:
0.32, 0.50, 0.60, 0.88, 1.44, <6, <6
AND
Sample 3/% max ratio value column: Change
83%
to:
61%






















Product column: Change
10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16
to:
10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625
AND
Sample 1/HCP ratio column: Change
4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6
to:
4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6
AND
Sample 2/HCP ratio column: Change
2.0, 3.3, 4.0, 5.9, 5.3, 6.1, <6
to:
2.00, 3.30, 4.00, 5.92, 5.28, 6.08, <6
AND
Sample 3/HCP ratio column: Change
0.3, 0.5, 0.6, 0.9, 1.4, <6, <6
to:
0.32, 0.50, 0.60, 0.88, 1.44, <6, <6
AN

Read more

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

SPECIFICATIONS/Polyethylene/Extractable Metals

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of Zirconium: Change
1 µg/g.
to:
0.1 µg/g.


Line 1 of Zirconium: Change
1 µg/g.
to:
0.1 µg/g.

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

TEST METHODS/Physicochemical Tests/Absorbance

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Line 3 of Plasticized polyvinyl chloride: Delete
Additionally, for nonplasticized polyvinyl chloride materials only, determine the spectrum between 250 and 330 nm in the alcohol sample associated with Solution S6.

Line 3 of Plasticized polyvinyl chloride: Delete
Additionally, for nonplasticized polyvinyl chloride materials only, determine the spectrum between 250 and 330 nm in the alcohol sample associated with Solution S6.

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

TEST METHODS/Extractions/Table 3

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of footnote b: Change
For nonplasticized polyethylene only.
to:
For polyethylene only.


Line 1 of footnote b: Change
For nonplasticized polyethylene only.
to:
For polyethylene only.

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

TEST METHODS/Extractions/Table 3

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Column 4 of S3 row: Change
Extractable metals: Al, Sb, As, Ba, Cd, Co, Ge, Hg, Mn, Ni, Pb, Ti, V, and Zn
to:
Extractable metals: Al, As, Ba, Cd, Co, Hg, Mn, Ni, Pb, Ti, V, and Zn


Column 4 of S3 row: Change
Extractable metals: Al, Sb, As, Ba, Cd, Co, Ge, Hg, Mn, Ni, Pb, Ti, V, and Zn
to:
Extractable metals: Al, As, Ba, Cd, Co, Hg, Mn, Ni, Pb, Ti, V, and Zn

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

SPECIFICATIONS/Polyethylene Terephthalate and Polyethylene Terephthalate G/Extractable Metals

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of Titanium: Change
0.1 µg/g.
to:
1 µg/g.


Line 1 of Titanium: Change
0.1 µg/g.
to:
1 µg/g.

<671> CONTAINERS--PERFORMANCE TESTING

MOISTURE VAPOR TRANSMISSION/Packaging System Classification for Multiple-Unit Containers and Unit-Dose Containers for Liquid Oral Dosage Forms/Procedure

USP38–NF33

465 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of the Equation: Change
[(W1iWT) − (W14iWT) − (WC1WC14)] × 365 × {[100/(W1iWT)] × 14}
to:
[(W1iWT) − (W14iWT) − (WC1WC14)] × 365 × 100/(W1i WT) × 14


Line 1 of the Equation: Change
[(W1iWT) − (W14iWT) − (WC1WC14)] × 365 × {[100/(W1iWT)] × 14}
to:
[(W1iWT) − (W14iWT) − (WC1WC14)] × 365 × 100/(W1i WT) × 14

<711> DISSOLUTION

INTERPRETATION/Immediate-Release Dosage Forms/Immediate-Release Dosage Forms Pooled Sample

USP39–NF34

540 01-Apr-2016

USP40–NF35

USP40–NF35

Row 3 of Column 1 of Acceptance Table for a Pooled Sample: Change
S1
to:
S2
AND
Row 4 of Column 1 of Acceptance Table for a Pooled Sample: Change
S1
to:
S3







Row 3 of Column 1 of Acceptance Table for a Pooled Sample: Change
S1
to:
S2
AND
Row 4 of Column 1 of Acceptance Table for a Pooled Sample: Change
S1
to:
S3

ARGININE HYDROCHLORIDE

SPECIFIC TESTS/Chloride Content

USP38–NF33

2279 01-Apr-2016

USP40–NF35

USP40–NF35

Delete the subsection
Blank: 140 mL of water and 1 mL of dichlorofluorescein TS
AND
The equation in the Analysis: Change
Result = [(VB) × N × F × 100]/W
to:
Result = (V × N × F × 100)/W
AND
Line 10 of Analysis: Delete
B = Blank titrant volume (mL)








Delete the subsection
Blank: 140 mL of water and 1 mL of dichlorofluorescein TS
AND
The equation in the Analysis: Change
Result = [(VB) × N × F × 100]/W
to:
Result = (V × N × F × 100)/W
AND
Line 10 of Analysis: Delete
B = Blank titrant volume (mL)

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS

IMPURITIES/Organic Impurities

USP39–NF34

2895 01-Apr-2016

USP40–NF35

USP40–NF35

Row 3 of Column 1 of Table 6:Change
Candesartan related compound Ab,c
to:
Candesartan cilexetil related compound Ab,c


Row 3 of Column 1 of Table 6:Change
Candesartan related compound Ab,c
to:
Candesartan cilexetil related compound Ab,c

DIGOXIN

IMPURITIES/Related Glycosides/System suitability

Interim Revision Announcement (Official November 01, 2015)

ONLINE 01-Apr-2016

USP40–NF35

USP40–NF35

Line 2: Change
Sample: System suitability solution
to:
Samples: System suitability solution and Standard solution
AND
Line 2 of Suitability requirements: Change
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections
to:
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks, System suitability solution
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections, Standard solution









Line 2: Change
Sample: System suitability solution
to:
Samples: System suitability solution and Standard solution
AND
Line 2 of Suitability requirements: Change
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections
to:
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks, System suitability solution
Relative standard deviation: NMT 2.0%, determined from the digoxin peak

Read more

DIPHENHYDRAMINE HYDROCHLORIDE INJECTION

ASSAY/Procedure

USP39–NF34

3529 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of System suitability solution:Change
USP Diphenhydramine Hydrochloride Related Compound A RS
to:
USP Diphenhydramine Related Compound A RS
AND
Line 4 of System suitability: Change
for diphenhydramine hydrochloride related compound A and diphenhydramine hydrochloride are
to:
for diphenhydramine related compound A and diphenhydramine are







Line 1 of System suitability solution:Change
USP Diphenhydramine Hydrochloride Related Compound A RS
to:
USP Diphenhydramine Related Compound A RS
AND
Line 4 of System suitability: Change
for diphenhydramine hydrochloride related compound A and diphenhydramine hydrochloride are
to:
for diphenhydramine related compound A and diphenhydramine are

FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER

ASSAY/Procedure

USP39–NF34

4020 01-Apr-2016

USP40–NF35

USP40–NF35

Line 3 of System suitability: Change
for salmeterol and fluticasone propionate are
to:
for fluticasone propionate and salmeterol are


Line 3 of System suitability: Change
for salmeterol and fluticasone propionate are
to:
for fluticasone propionate and salmeterol are

MEMANTINE HYDROCHLORIDE TABLETS

IMPURITIES/Organic Impurities

Revision Bulletin (Official October 01, 2015)

ONLINE 01-Apr-2016

USP40–NF35

USP40–NF35

Line 3 of Analysis: Change
of USP Memantine Related Compound E RS or
to:
of memantine related compound E or
AND
In the variable definition list: Change
rU = peak response of USP Memantine Related Compound E RS or any individual degradation product from the Sample solution
to:
rU = peak response of memantine related compound E or any individual degradation product from the Sample solution







Line 3 of Analysis: Change
of USP Memantine Related Compound E RS or
to:
of memantine related compound E or
AND
In the variable definition list: Change
rU = peak response of USP Memantine Related Compound E RS or any individual degradation product from the Sample solution
to:
rU = peak response of memantine related compound E or any individual degradation product from the Sample solution

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

IMPURITIES/Limit of Methacrylic Acid and Ethyl Acrylate

First Supplement to USP39–NF34

ONLINE 01-Apr-2016

USP40–NF35

USP40–NF35

Line 5 of Standard solution: Change
Mix 10.0 mL of this solution
to:
Mix 5.0 mL of this solution
AND
Line 7 of Standard solution: Change
about 0.67 µg/mL
to:
about 0.5 µg/mL
Line 4 of Sample solution: Change
10.0 mL of this solution
to:
5.0 mL of this solution
AND
In the variable definition list in Analysis: Change
VF = final volume of the Sample solution, 15 mL
D = dilution factor for preparation of the Sample solution, 5
to:
VF = final volume of the Sample solution, 10 mL
D = dilution factor for preparation of the Sample solution, 10


















Line 5 of Standard solution: Change
Mix 10.0 mL of this solution
to:
Mix 5.0 mL of this solution
AND
Line 7 of Standard solution: Change
about 0.67 µg/mL
to:
about 0.5 µg/mL
Line 4 of Sample solution: Change
10.0 mL of this solution
to:
5.0 mL of this solution
AND
In the variable definition list in Analysis: Change
VF = final volume of the Sample solution, 15 mL
D = dilution factor for preparation of the Sample solution, 5
to:
VF =

Read more

SELENOMETHIONINE

CHEMICAL INFORMATION

USP38–NF33

6226 01-Apr-2016

USP40–NF35

USP40–NF35

Line 3: Change
[1464-42-2]
to:
[3211-76-5]


Line 3: Change
[1464-42-2]
to:
[3211-76-5]

ALTEPLASE

ASSAY/Biological Potency

USP39–NF34

2398 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 1 of Human thrombin solution: Change
33 Units in terms of the U.S. Standard Thrombin/mL in Buffer
to:
33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer
AND
Line 5 of Analysis: Change
Standard solution and Sample solution,
to:
Standard solution or Sample solution,

Line 1 of Human thrombin solution: Change
33 Units in terms of the U.S. Standard Thrombin/mL in Buffer
to:
33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer
AND
Line 5 of Analysis: Change
Standard solution and Sample solution,
to:
Standard solution or Sample solution,

ALTEPLASE FOR INJECTION

ASSAY/Biological Potency

USP39–NF34

2401 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 1 of Human thrombin solution: Change
33 Units in terms of the U.S. Standard Thrombin/mL in Buffer
to:
33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer
AND
Line 5 of Analysis: Change
Standard solution and Sample solution,
to:
Standard solution or Sample solution,

Line 1 of Human thrombin solution: Change
33 Units in terms of the U.S. Standard Thrombin/mL in Buffer
to:
33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer
AND
Line 5 of Analysis: Change
Standard solution and Sample solution,
to:
Standard solution or Sample solution,

DEXAMETHASONE SODIUM PHOSPHATE INJECTION

ASSAY/Procedure

Interim Revision Announcement (Official May 01, 2015)

ONLINE 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 9 of Analysis: Change
CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL)

Line 9 of Analysis: Change
CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL)

DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION

ASSAY/Procedure

Interim Revision Announcement (Official May 01, 2015)

ONLINE 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 9 of Analysis: Change
CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL)

Line 9 of Analysis: Change
CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL)

DEXTROAMPHETAMINE SULFATE

ASSAY/Procedure

USP38–NF33

3060 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 1 of System suitability solution: Change
0.02 µg/mL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS in Standard solution
to:
Transfer about 40 mL of the Standard solution to a 50-mL volumetric flask. Using a microliter syringe, add 1 µL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS. Dilute with Standard solution to volume.

Line 1 of System suitability solution: Change
0.02 µg/mL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS in Standard solution
to:
Transfer about 40 mL of the Standard solution to a 50-mL volumetric flask. Using a microliter syringe, add 1 µL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS. Dilute with Standard solution to volume.

DONEPEZIL HYDROCHLORIDE

IMPURITIES/Organic Impurities/Procedure 2

First Supplement to USP38–NF33

7384 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Footnote h of Table 3: Change
1-Benzyl-4-[(5,6-dimethoxyindan-2-yl)methyl]piperidine.
to:
1-Benzyl-4-[(5,6-dimethoxyinden-2-yl)methyl]piperidine.


Footnote h of Table 3: Change
1-Benzyl-4-[(5,6-dimethoxyindan-2-yl)methyl]piperidine.
to:
1-Benzyl-4-[(5,6-dimethoxyinden-2-yl)methyl]piperidine.

GALANTAMINE HYDROBROMIDE

IMPURITIES/Organic Impurities

USP38–NF33

3646 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 8 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (1/F) × (100/100 − L)
to:
Result = (rU/rS) × (CS/CU) × (1/F) × (100/[100 − L])

Line 8 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (1/F) × (100/100 − L)
to:
Result = (rU/rS) × (CS/CU) × (1/F) × (100/[100 − L])

GALANTAMINE TABLETS

PERFORMANCE TESTS/Dissolution

USP38–NF33

3649 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 6 of Analysis in Test 1: Change
Result = (AU/AS) × (CS/L) × (Mr1/Mr2) × 100
to:
Result = (AU/AS) × (CS/L) × (Mr1/Mr2) × V × 100
AND
Add to the variable definition list in Test 1
V = volume of Medium, 500 mL
AND
Equation in Test 3: Change
Result = (rU/rS) × (CS/L) × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × (CS/L) × (Mr1/Mr2) × V × 100
AND
Add to the variable definition list in Test 3
V = volume of Medium, 500 mL

Line 6 of Analysis in Test 1: Change
Result = (AU/AS) × (CS/L) × (Mr1/Mr2) × 100
to:
Result = (AU/AS) × (CS/L) × (Mr1/Mr2) × V × 100
AND
Add to the variable definition list in Test 1
V = volume of Medium, 500 mL
AND

Read more

GLUCOSAMINE SULFATE POTASSIUM CHLORIDE

CHEMICAL INFORMATION

USP38–NF33

6074 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 5: Change
[38899-05-7].
to:
[1296149-08-0].

Line 5: Change
[38899-05-7].
to:
[1296149-08-0].

GLUCOSAMINE SULFATE SODIUM CHLORIDE

CHEMICAL INFORMATION

USP38–NF33

6075 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 5: Change
[38899-05-7].
to:
[1296149-13-7].

Line 5: Change
[38899-05-7].
to:
[1296149-13-7].

HYDROCHLORIC ACID INJECTION

ASSAY/Procedure

USP38–NF33

3770 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 8 of Analysis: Change
F = equivalency factor, 18.23 mg/mEq
to:
F = equivalency factor, 36.46 mg/mEq

Line 8 of Analysis: Change
F = equivalency factor, 18.23 mg/mEq
to:
F = equivalency factor, 36.46 mg/mEq

IMIQUIMOD CREAM

SPECIFIC TESTS/pH <791>

First Supplement to USP38–NF33

7409 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 1 of Sample: Change
Nominally 50 mg/mL of imiquimod from Cream in water.
to:
Nominally 2.5 mg/mL of imiquimod from Cream in water.

Line 1 of Sample: Change
Nominally 50 mg/mL of imiquimod from Cream in water.
to:
Nominally 2.5 mg/mL of imiquimod from Cream in water.

NIFEDIPINE EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 9

Revision Bulletin (Official December 01, 2015)

ONLINE 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 4 of Medium: Change
6 g/L
to:
10 g/L

Line 4 of Medium: Change
6 g/L
to:
10 g/L

RISPERIDONE TABLETS

Assay

USP38–NF33

5195 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 4 of Procedure: Change
Calculate the quantity, in mg, of risperidone
to:
Calculate the percentage of the labeled amount of risperidone

Line 4 of Procedure: Change
Calculate the quantity, in mg, of risperidone
to:
Calculate the percentage of the labeled amount of risperidone

ROPINIROLE TABLETS

IMPURITIES/Organic Impurities

USP39–NF34

5756 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Footnote b of Table 2: Change
4-[2-(Dipropylnitroryl)ethyl]-1,3-dihydrox-2H-indol-2-one.
to:
N-[2-(2-Oxoindolin-4-yl)ethyl]-N-propylpropan-1-amine oxide.

Footnote b of Table 2: Change
4-[2-(Dipropylnitroryl)ethyl]-1,3-dihydrox-2H-indol-2-one.
to:
N-[2-(2-Oxoindolin-4-yl)ethyl]-N-propylpropan-1-amine oxide.

TAMSULOSIN HYDROCHLORIDE CAPSULES

ASSAY/Procedure 8

USP38–NF33

5442 01-Feb-2016

USP40–NF35

Second Supplement to USP39–NF34

Line 1 of Standard solution: Change
Prepare a solution containing 1.0 mg/mL of USP Tamsulosin Hydrochloride RS in methanol.
to:
Prepare a solution containing 0.1 mg/mL of USP Tamsulosin Hydrochloride RS in methanol.
AND
Line 6 of Sample solution: Change
Add 30 mL of Mobile phase, and shake by mechanical means for 30 min.
to:
Add 30 mL of Mobile phase, shake by mechanical means for 30 min, and dilute with Mobile phase to volume.

Line 1 of Standard solution: Change
Prepare a solution containing 1.0 mg/mL of USP Tamsulosin Hydrochloride RS in methanol.
to:
Prepare a solution containing 0.1 mg/mL of USP Tamsulosin Hydrochloride RS in methanol.
AND
Line 6 of Sample solution: Change
Add 30 mL of Mobile phase, and shake by mechanical means for 30 min.
to:
Add 30 mL of Mobile phase, shake by mechanical means for 30 min, and dilute with Mobile phase to volume.

<601> INHALATION AND NASAL DRUG PRODUCTS—AEROSOLS, SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS

C. AERODYNAMIC SIZE DISTRIBUTION—INHALATION AEROSOLS, SPRAYS, AND POWDERS

USP38–NF33

388 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 13 of paragraph 2 of C.3 Apparatus 2 for Inhalation Powders—Marple Miller Impactor/C.3.1 Design—Apparatus 2: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration of T seconds as determined during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.
AND
Line 3 of paragraph 2 of C.4 Apparatus 3 for Inhalation Powders—Andersen Impactor (with pre-separator)/C.4.1 Design—Apparatus 3: Change
Once the product is positioned, discharge the powder into the apparatus by activating the timer and opening the two-way solenoid valve for the required duration, T ± 5%, as determined during testing for Delivered-Dose Uniformity.
to:
Once the product is positioned, discharge the powder into the apparatus by activating the timer and opening the two-way solenoid valve for the required duration such that the total volume sampled is at least 4 L.
AND
Line 19 of paragraph 2 of C.5 Apparatus 4 for Inhalation Powders—Multistage Liquid Impinger/C.5.1 Design—Apparatus 4: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the same duration, T, as used during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the duration such that the total volume sampled is at least 4 L.
AND
Line 9 of paragraph 4 of C.6 Apparatus 5 for Inhalation Powders—Next Generation Impactor (with pre-separator)/C.6.2 Procedure—Apparatus 5: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the same duration, T, as used during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.

Line 13 of paragraph 2 of C.3 Apparatus 2 for Inhalation Powders—Marple Miller Impactor/C.3.1 Design—Apparatus 2: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration of T seconds as determined during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.
AND

Read more

<659> PACKAGING AND STORAGE REQUIREMENTS

GENERAL DEFINITIONS

USP38–NF33

447 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

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:

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<852> ATOMIC ABSORPTION SPECTROSCOPY

VALIDATION AND VERIFICATION/Precision/Intermediate Precision

USP38–NF33

649 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 3: Change
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any of the conditions previously mentioned (totaling 12 measurements).
to:
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any combination of at least two of the conditions previously mentioned (totaling 12 measurements).

Line 3: Change
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any of the conditions previously mentioned (totaling 12 measurements).
to:
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any combination of at least two of the conditions previously mentioned (totaling 12 measurements).

CEFDINIR FOR ORAL SUSPENSION

PERFORMANCE TESTS/Dissolution <711>

First Supplement to USP38–NF33

7357 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 5 of Analysis: Change
Result = (AU/AS) × CS × d × V × D × (1/L) × 100
to:
Result = (AU/AS) × CS × (d/WU) × V × D × (1/L) × 100
AND
Add to the variable definition list
WU = weight of reconstituted Cefdinir for Oral Suspension taken (mg)

Line 5 of Analysis: Change
Result = (AU/AS) × CS × d × V × D × (1/L) × 100
to:
Result = (AU/AS) × CS × (d/WU) × V × D × (1/L) × 100
AND
Add to the variable definition list
WU = weight of reconstituted Cefdinir for Oral Suspension taken (mg)

CORTICOTROPIN FOR INJECTION

ASSAY/Procedure

Second Supplement to USP38–NF33

8061 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 7 of Replication: Change
(see <111>, Confidence Intervals for Individual Assays).
to:
(see <111>, The Confidence Interval and Limits of Potency).

Line 7 of Replication: Change
(see <111>, Confidence Intervals for Individual Assays).
to:
(see <111>, The Confidence Interval and Limits of Potency).

CORTICOTROPIN INJECTION

ASSAY/Procedure

Second Supplement to USP38–NF33

8059 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 7 of Replication: Change
(see <111>, Confidence Intervals for Individual Assays).
to:
(see <111>, The Confidence Interval and Limits of Potency).

Line 7 of Replication: Change
(see <111>, Confidence Intervals for Individual Assays).
to:
(see <111>, The Confidence Interval and Limits of Potency).

CYCLOBENZAPRINE HYDROCHLORIDE TABLETS

IMPURITIES/Organic Impurities/Analysis

USP38–NF33

2972 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 3: Change
Calculate the percentage of any individual unspecified degradation product
to:
Calculate the percentage of any individual degradation product
AND
Line 6: Change
rU = peak response of any individual unspecified degradation product from the Sample solution
to:
rU = peak response of any individual degradation product from the Sample solution

Line 3: Change
Calculate the percentage of any individual unspecified degradation product
to:
Calculate the percentage of any individual degradation product
AND
Line 6: Change
rU = peak response of any individual unspecified degradation product from the Sample solution
to:
rU = peak response of any individual degradation product from the Sample solution

DESCRIPTION AND SOLUBILITY

SUNFLOWER OIL

Second Supplement to USP38–NF33

7761 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 5: Change
NF category: Coating agent; emollient; solvent; tablet and/or capsule diluent; vehicle (oleaginous).
to:
NF category: Coating agent; emollient; solvent; diluent; vehicle (oleaginous).

Line 5: Change
NF category: Coating agent; emollient; solvent; tablet and/or capsule diluent; vehicle (oleaginous).
to:
NF category: Coating agent; emollient; solvent; diluent; vehicle (oleaginous).

DILUTED ISOSORBIDE MONONITRATE

USP Reference standards <11>

USP38–NF33

3973 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 2 of USP Diluted Isosorbide Mononitrate Related Compound A RS: Change
1,4:3,5-Dianhydro-D-glucitol 2-nitrate.
to:
1,4:3,6-Dianhydro-D-glucitol 2-nitrate.

Line 2 of USP Diluted Isosorbide Mononitrate Related Compound A RS: Change
1,4:3,5-Dianhydro-D-glucitol 2-nitrate.
to:
1,4:3,6-Dianhydro-D-glucitol 2-nitrate.

ISOSORBIDE MONONITRATE TABLETS

USP Reference standards <11>

USP38–NF33

3974 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 2 of USP Diluted Isosorbide Mononitrate Related Compound A RS: Change
1,4:3,5-Dianhydro-D-glucitol 2-nitrate.
to:
1,4:3,6-Dianhydro-D-glucitol 2-nitrate.

Line 2 of USP Diluted Isosorbide Mononitrate Related Compound A RS: Change
1,4:3,5-Dianhydro-D-glucitol 2-nitrate.
to:
1,4:3,6-Dianhydro-D-glucitol 2-nitrate.

LIGHT MINERAL OIL

SPECIFIC TESTS/Readily Carbonizable Substances Test <271>

USP38–NF33

6763 01-Dec-2015

USP40–NF35

Second Supplement to 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.

LOPINAVIR AND RITONAVIR ORAL SOLUTION

IMPURITIES/Organic Impurities

Second Supplement to USP38–NF33

8139 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Row 17 of Column 3 of Table 2: Change
0.2
to:
0.2p
AND
Add footnote
pDisregard any peak less than 0.01%.

Row 17 of Column 3 of Table 2: Change
0.2
to:
0.2p
AND
Add footnote
pDisregard any peak less than 0.01%.

MANNITOL INJECTION

Specific rotation <781>

Second Supplement to USP38–NF33

ONLINE 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 1: Change
Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask:it meets the requirements of the test for Specific rotation under Mannitol.
to:
+137° to +145°.Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask. Add 40 mL of a 1-in-10 ammonium molybdate solution, previously filtered if necessary. Add 20 mL of 1 N sulfuric acid, and dilute with water to volume.

Line 1: Change
Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask:it meets the requirements of the test for Specific rotation under Mannitol.
to:

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METAXALONE TABLETS

PERFORMANCE TESTS/Dissolution <711>

First Supplement to USP38–NF33

7432 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 2 of Buffer, Mobile phase, Chromatographic system, and System suitability: Change
Proceed as directed in the Assay.
to:
Proceed as directed in the Assay, except use 270 nm for analysis.
AND
Line 10 of Analysis: Change
V = volume of the Medium, 750 mL
to:
V = volume of the Medium, 900 mL

Line 2 of Buffer, Mobile phase, Chromatographic system, and System suitability: Change
Proceed as directed in the Assay.
to:
Proceed as directed in the Assay, except use 270 nm for analysis.
AND
Line 10 of Analysis: Change
V = volume of the Medium, 750 mL
to:
V = volume of the Medium, 900 mL

MILK THISTLE

COMPOSITION/Content of Silymarin

Second Supplement to USP38–NF33

7878 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Line 3 of Sample stock solution: Change
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the hexane. Dry the extraction thimble to remove residual hexane,
to:
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of solvent hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the solvent hexane. Dry the extraction thimble to remove residual solvent hexane,

Line 3 of Sample stock solution: Change
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the hexane. Dry the extraction thimble to remove residual hexane,
to:

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MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS

IMPURITIES/Organic Impurities

Second Supplement to USP38–NF33

8158 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Row 6 of Column 2 of Table 5: Change
0.62
to:
0.82

Row 6 of Column 2 of Table 5: Change
0.62
to:
0.82

OLMESARTAN MEDOXOMIL

IMPURITIES/Organic Impurities

USP38–NF33

4622 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Footnote d of Impurity Table: Change
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.
to:
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.

Footnote d of Impurity Table: Change
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.
to:
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION

IMPURITIES/Limit of Late Eluting Impurities

USP38–NF33

4625 01-Dec-2015

USP40–NF35

Second Supplement to USP39–NF34

Add
[Note–Protect solutions from light.]

Add
[Note–Protect solutions from light.]

XLS CSV