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 Titlesort icon Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
<1050> VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN VI. Evaluation and Characterization of Viral Clearance Procedures USP35–NF30 553 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Row 10 (Reovirus 3) of Column 5 (Genome) of Table A-1: Change
DNA
to:
RNA

Row 10 (Reovirus 3) of Column 5 (Genome) of Table A-1: Change
DNA
to:
RNA

<1079> GOOD STORAGE AND DISTRIBUTION PRACTICES FOR DRUG PRODUCTS QUALITY MANAGEMENT SYSTEM/Storage Management System/Receiving and Transferring Drug Products USP36–NF31 693 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of footnote 1: Change
JP Edmond,
to:
JP Emond,

Line 1 of footnote 1: Change
JP Edmond,
to:
JP Emond,

<232> ELEMENTAL IMPURITIES--LIMITS Drug Products/Large Volume Parenterals Second Supplement to USP35–NF30 5633 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Row 16 of Column 4 of Table 1: Change
70
to:
100
AND
Row 16 of Column 5 of Table 1: Change
25
to:
10

Row 16 of Column 4 of Table 1: Change
70
to:
100
AND
Row 16 of Column 5 of Table 1: Change
25
to:
10

<232> ELEMENTAL IMPURITIES--LIMITS Drug Substance and Excipients Second Supplement to USP35–NF30 5633 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Row 16 of Column 4 of Table 2: Change
7
to:
10

Row 16 of Column 4 of Table 2: Change
7
to:
10

<232> ELEMENTAL IMPURITIES—LIMITS DRUG SUBSTANCE AND EXCIPIENTS Second Supplement to USP35–NF30 5633 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Rows 11 and 15 of Column 2 of Table 2: Change
100
to:
10
AND
Rows 11 and 15 of Column 3 of Table 2: Change
10
to:
1.0
AND
Row 11 of Column 4 of Table 2: Change
1.5
to:
0.15
AND
Row 15 of Column 4 of Table 2: Change
30
to:
3.0

Rows 11 and 15 of Column 2 of Table 2: Change
100
to:
10
AND
Rows 11 and 15 of Column 3 of Table 2: Change
10
to:
1.0
AND
Row 11 of Column 4 of Table 2: Change
1.5
to:
0.15
AND
Row 15 of Column 4 of Table 2: Change
30
to:
3.0

<232> ELEMENTAL IMPURITIES—LIMITS ANALYTICAL TESTING Second Supplement to USP35–NF30 5633 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 6: Change
Pd
to:
Pb

Line 6: Change
Pd
to:
Pb

<232> ELEMENTAL IMPURITIES—LIMITS DRUG SUBSTANCE AND EXCIPIENTS Second Supplement to USP35–NF30 5633 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Row 13 of Column 4 of Table 2: Change
25
to:
1.0

Row 13 of Column 4 of Table 2: Change
25
to:
1.0

<232> ELEMENTAL IMPURITIES—LIMITS DRUG PRODUCTS/Large Volume Parenterals Second Supplement to USP35–NF30 5633 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Row 13 of Column 4 of Table 1: Change
250
to:
10

Row 13 of Column 4 of Table 1: Change
250
to:
10

<233> ELEMENTAL IMPURITIES—PROCEDURES INTRODUCTION/Definition Second Supplement to USP35–NF30 5634 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 2 of Target Elements: Change
Pd
to:
Pb

Line 2 of Target Elements: Change
Pd
to:
Pb

<621> CHROMATOGRAPHY SYSTEM SUITABILITY/Stationary Phase USP35–NF30 258 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Flow Rate (HPLC): Change
Monograph Image
in which F1 is the flow rate indicated in the monograph, in mL/min; F2 is the adjusted flow rate, in mL/min; l1 is the length of the column indicated in the monograph; l2 is the length of the column used; d1 is the column inner diameter indicated in the monograph; and d2 is the internal diameter of the column used. Additionally, the flow rate can be adjusted by ±50%.
to:
Monograph Image
in which F1 is the flow rate indicated in the monograph, in mL/min; F2 is the adjusted flow rate, in mL/min; d1 is the column inner diameter indicated in the monograph; and d2 is the internal diameter of the column used. Additionally, the flow rate can be adjusted by ±50%.

Line 3 of Flow Rate (HPLC): Change

Read More
<660> Containers—Glass SPECIFIC TESTS/Hydrolytic Resistance/Method First Supplement to USP35–NF30 5150 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
In the Note in line 11 of Titration: Change
Rinse the grains by swirling with three 15-mL portions of Purified Water, and add the washings to the main solution.
to:
Rinse the grains by swirling with three 15-mL portions of Carbon Dioxide-Free Water, and add the washings to the main solution.

In the Note in line 11 of Titration: Change
Rinse the grains by swirling with three 15-mL portions of Purified Water, and add the washings to the main solution.
to:
Rinse the grains by swirling with three 15-mL portions of Carbon Dioxide-Free Water, and add the washings to the main solution.

<698> DELIVERABLE VOLUME ACCEPTANCE CRITERIA/For Multiple-Unit Containers First Supplement to USP35–NF30 5154 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Figure 1, right branch, left box: Change
Volume of 1 more containers is less than 95% LV
to:
Volume of 1 or more containers is less than 95% LV

Figure 1, right branch, left box: Change

Volume of 1 more containers is less than 95% LV
to:

Volume of 1 or more containers is less than 95% LV

<81> Antibiotics—Microbial Assays Turbidimetric Method USP35–NF30 74 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 8 of Analysis: Change
Include in each rack 1–2 control tubes containing 1 mL of the inoculum medium (see Table 8) but no antibiotic.
to:
Include in each rack 1–2 control tubes containing 1 mL of the test diluent (see Table 7) but no antibiotic.

Line 8 of Analysis: Change
Include in each rack 1–2 control tubes containing 1 mL of the inoculum medium (see Table 8) but no antibiotic.
to:
Include in each rack 1–2 control tubes containing 1 mL of the test diluent (see Table 7) but no antibiotic.

ACESULFAME POTASSIUM IMPURITIES/Limit of Fluoride USP35–NF30 1680 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 25 of Analysis: Change
C = concentration of fluoride in the Sample solution, from the standard curve (mg/mL)
to:
C = concentration of fluoride in the Sample solution, from the standard curve (µg/mL)

Line 25 of Analysis: Change
C = concentration of fluoride in the Sample solution, from the standard curve (mg/mL)
to:
C = concentration of fluoride in the Sample solution, from the standard curve (µg/mL)

ACETAZOLAMIDE FOR INJECTION ASSAY USP35–NF30 2063 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 19: Change
25C(AU/AS)
to:
250C(AU/AS)

Line 19: Change
25C(AU/AS)

to:
250C(AU/AS)

ADAPALENE IMPURITIES/Residual Solvent: Limit of Triethylamine Revision Bulletin (Official December 01, 2012) Online 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Diluent: Change
Dimethyl sulfoxide and 1 N sodium hydroxide solution (4:1)
to:
Dimethyl sulfoxide
AND
Line 1 of Standard solution: Change
3.2 μg/mL of USP Triethylamine RS in Diluent
to:
4.0 μg/mL of USP Triethylamine RS in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.
AND
Line 1 of Sample solution: Change
40 mg/mL of Adapalene in Diluent
to:
50 mg/mL of Adapalene in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.

Line 1 of Diluent: Change
Dimethyl sulfoxide and 1 N sodium hydroxide solution (4:1)

to:
Dimethyl sulfoxide
AND
Line 1 of Standard solution: Change
3.2 μg/mL of USP Triethylamine RS in Diluent
to:
4.0 μg/mL of USP Triethylamine RS in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.
AND
Line 1 of Sample solution: Change
40 mg/mL of Adapalene in Diluent
to:

Read More
ADENOSINE IDENTIFICATION/Infrared Absorption <197M> USP35–NF30 2079 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1:
Delete NMT 0.1%

Line 1:
Delete
NMT 0.1%

ALLANTOIN IDENTIFICATION First Supplement to USP35–NF30 5429 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of B. Thin-Layer Chromatographic Identification Test <201>: Change
The RF value of the principal spot from Sample solution A corresponds to that from Standard solution A, as described in the test for Organic Impurities.
to:
The RF value of the principal spot from Sample solution B corresponds to that from Standard solution A, as described in the test for Organic Impurities.

Line 1 of B. Thin-Layer Chromatographic Identification Test <201>: Change
The RF value of the
principal spot from Sample solution A corresponds to that from Standard solution A, as
described in the test for Organic Impurities.
to:
The RF value of the
principal spot from Sample solution B corresponds to that from Standard solution A, as
described in the test for Organic Impurities.

ALPRAZOLAM ORALLY-DISINTEGRATING TABLETS IMPURITIES/Procedure USP35–NF30 2106 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Change the subsection
Buffer and Diluent: Prepare as directed in the Assay.
to:
Diluent: Prepare as directed in the Assay.
Buffer: 6.8 g/L of monobasic potassium phosphate in water. Adjust with phosphoric acid to a pH of 3.0.

Change the subsection

Buffer and Diluent: Prepare as directed in the Assay.

to:

Diluent: Prepare as directed in the Assay.

Buffer: 6.8 g/L of monobasic potassium phosphate in
water. Adjust with phosphoric acid to a pH of 3.0.

AMANTADINE HYDROCHLORIDE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 2 USP35–NF30 2153 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Chromatographic system: Change
Column: 0.32-mm × 30-cm, 0.25-μm film, phase G1
to:
Column: 0.32-mm × 30-m, 0.25-μm film, phase G1

Line 5 of Chromatographic system: Change
Column: 0.32-mm × 30-cm, 0.25-μm film, phase G1

to:
Column: 0.32-mm × 30-m, 0.25-μm film, phase G1

Aminosalicylate Sodium Limit of m-aminophenol USP35–NF30 2177 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Test preparation: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Transfer about 69 mg of Aminosalicylate Sodium, accurately weighed, to a 100-mL low-actinic volumetric flask, add 50 mL of Mobile phase, and swirl to dissolve. Add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Line 1 of Test preparation: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Transfer about 69 mg of Aminosalicylate Sodium, accurately weighed, to a 100-mL low-actinic volumetric flask, add 50 mL of Mobile phase, and swirl to dissolve. Add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Aminosalicylate Sodium Tablets Limit of m-aminophenol USP35–NF30 2178 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 690 mg of aminosalicylate sodium, to a 100-mL low-actinic volumetric flask. Add 50 mL of Mobile phase, and shake for about 5 minutes. Dilute with Mobile phase to volume, and mix. Filter, and transfer 10.0 mL of the clear filtrate to a low-actinic, 100-mL volumetric flask containing 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:

Read More
Aminosalicylic Acid Tablets Limit of m-aminophenol USP35–NF30 2179 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Change the subsection:
Mobile phase and Internal standard solution—Prepare as directed in the Assay under Aminosalicylic Acid.
to:
Mobile phase—Prepare as directed in the Assay under Aminosalicylic Acid.
Internal standard solution—Prepare a solution of sulfanilamide in Mobile phase having a concentration of about 5 µg per mL.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 500 mg of aminosalicylic acid, to a 100-mL low-actinic volumetric flask. Add 50 mL of Mobile phase, and shake for about 5 minutes. Dilute with Mobile phase to volume, and mix. Filter, and transfer 10.0 mL of the clear filtrate to a 100-mL low-actinic volumetric flask containing 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Change the subsection:
Mobile phase and Internal standard solution—Prepare as directed in the Assay under Aminosalicylic Acid.
to:

Mobile phase—Prepare as directed in the Assay under
Aminosalicylic Acid.
Internal standard solution—Prepare a solution of sulfanilamide
in Mobile phase having a concentration of
about 5 µg per mL.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in
the Assay.
to:

Read More
AMOXICILLIN TABLETS PERFORMANCE TESTS USP35–NF30 2202 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 4 of Analysis: Change
Result = (rU/rS) × (CS/L) × (D/V) × P × F × 100
to:
Result = (rU/rS) × (CS/L) × V × D × P × F × 100
AND
Transpose lines 12 and 13 of the variable definition list to match the order in the equation

Line 4 of Analysis: Change

Result = (rU/rS) × (CS/L) × (D/V) × P × F × 100

to:

Result = (rU/rS) × (CS/L) × V × D × P × F × 100
AND

Transpose lines 12 and 13 of the variable definition list to match the order in the equation

Ampicillin Sodium SPECIFIC TESTS/pH <791> USP35–NF30 2213 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 2: Change text of Sample solution from
10.0 mg/mL
to:
10.0 mg/mL of ampicillin

Line 2: Change text of Sample solution from
10.0 mg/mL
to:
10.0 mg/mL of ampicillin

Anhydrous Dibasic Calcium Phosphate ASSAY USP35–NF30 2464 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
In line 14 of Analysis: Change
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution

In line 14 of Analysis: Change
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution

Anhydrous Dibasic Calcium Phosphate IMPURITIES/Heavy Metals, Method I <231> USP35–NF30 2464 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Test preparation: Change
Warm 1.3 g with 3 mL of 3 N hydrochloric acid to completely dissolve.
to:
Warm 1.3 g with 3 mL of 3 N hydrochloric acid until no more dissolves.

Line 1 of Test preparation: Change
Warm 1.3 g with 3 mL of 3 N hydrochloric acid to completely dissolve.

to:
Warm 1.3 g with 3 mL of 3 N hydrochloric acid until no more dissolves.

ATRACURIUM BESYLATE INJECTION IMPURITIES/Organic Impurities/Acceptance criteria/Table 2 Second Supplement to USP35–NF30 5909 01-Apr-2013 USP37–NF32 USP37–NF32
Footnote b: Change
cis isomer of the hydroxy compound.
to:
trans isomer of the hydroxy compound.
AND
Footnote c: Change
trans isomer of the hydroxy compound.
to:
cis isomer of the hydroxy compound.
AND
Footnote d: Change
cis isomer of the monoacrylate.
to:
trans isomer of the monoacrylate.
AND
Footnote e: Change
trans isomer of the monoacrylate.
to:
cis isomer of the monoacrylate.

Footnote b: Change
cis isomer of the hydroxy compound.
to:
trans isomer of the hydroxy compound.
AND
Footnote c: Change
trans isomer of the hydroxy compound.
to:
cis isomer of the hydroxy compound.
AND
Footnote d: Change

cis isomer of the monoacrylate.
to:
trans isomer of the monoacrylate.
AND
Footnote e: Change
trans isomer of the monoacrylate.
to:
cis isomer of the monoacrylate.

ATROPINE SULFATE TABLETS Assay USP35–NF30 2272 01-Apr-2013 USP37–NF32 USP37–NF32
Line 9 of Procedure: Change
RU and RS are as defined therein.
to:
RU and RS are the peak area ratios of atropine to homatropine.

Line 9 of Procedure: Change
RU and RS are as defined therein.
to:
RU and RS are the peak area ratios of atropine to homatropine.

AZITHROMYCIN IMPURITIES/Organic Impurities/Procedure 2 USP35–NF30 2279 01-Apr-2013 USP37–NF32 USP37–NF32
Line 15 of Analysis: Change
CS = concentration of USP Azithromycin RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Azithromycin RS in the Standard solution (mg/mL)
AND
Add after CU:
P = potency of USP Azithromycin RS (µg/mg of azithromycin)

Line 15 of Analysis: Change
CS = concentration of USP Azithromycin RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Azithromycin RS in the Standard solution (mg/mL)
AND
Add after CU:
P = potency of USP Azithromycin RS (µg/mg of azithromycin)

AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Aminoazithromycin, Formamido Analog, Methylformamido Analog, and 3’-De(dimethylamino)-3’-oxoazithromycin (if present) Second Supplement to USP35–NF30 5910 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Buffer: Change
3.5 g/mL
to:
3.5 g/L

Line 1 of Buffer: Change
3.5 g/mL
to:
3.5 g/L

AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Aminoazithromycin, Formamido Analog, Methylformamido Analog, and 3′-De(dimethylamino)-3′-oxoazithromycin Second Supplement to USP35–NF30 5910 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Row 11 of Table 2: Change
3′-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin
to:
3′-N-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin

Row 11 of Table 2: Change
3′-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin
to:
3′-N-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin

AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Azithromycin N-Oxide, Desosaminylazithromycin, and N-Demethylazithromycin Second Supplement to USP35–NF30 5910 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × P × F × 100
to:
Result = (rU/rS) × (CS/CU) × P × 100

Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × P × F × 100
to:
Result = (rU/rS) × (CS/CU) × P × 100

BENTONITE IDENTIFICATION/A. X-Ray Diffraction <941> USP35–NF30 1705 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
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.

BENZTROPINE MESYLATE CHEMICAL INFORMATION USP36–NF31 2628 01-Apr-2013 USP37–NF32 USP37–NF32
Line 2: Change
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-, endo-, methanesulfonate;
to:
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-N-methyl-, endo-, methanesulfonate;

Line 2: Change
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-, endo-, methanesulfonate;
to:
8-Azabicyclo[3.2.1]octane, 3-(diphenylmethoxy)-N-methyl-, endo-, methanesulfonate;

BETAMETHASONE ORAL SOLUTION Identification/A: USP35–NF30 2336 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1: Change
A:
to:
A: Thin-Layer Chromatographic Identification Test <201>—

Line 1: Change
A:

to:
A:
Thin-Layer Chromatographic Identification Test <201>—

BRINZOLAMIDE Related compounds/Test 2 USP35–NF30 2385 01-Apr-2013 USP37–NF32 USP37–NF32
Line 15 of Procedure: Change
relative retention time greater than 6.
to:
relative retention greater than 6.

Line 15 of Procedure: Change
relative retention time greater than 6.
to:
relative retention greater than 6.

Budesonide ASSAY/Procedure USP35–NF30 2394 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 2 of Acceptance criteria: Change
Epimer A: 40.0%–51.0% on the dried basis
to:
Epimer A: 40.0%–51.0%

Line 2 of Acceptance criteria: Change
Epimer A: 40.0%–51.0% on the dried basis

to:
Epimer A: 40.0%–51.0%

CALCIUM SULFATE ASSAY/Procedure USP35–NF30 1724 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 5 of Titrimetric system: Delete the subsection
Blank: 100 mL of water and 4 mL of 3 N hydrochloric acid
AND
Line 11 of Analysis: Delete the sentence
Perform a blank determination.
AND
Line 13 of Analysis: Change
Result = [(VB) × N × F × 100]/W
to:
Result = [(V × N × F)/W] × 100
AND
Line 15 of Analysis: Delete
B = volume of titrant consumed by the Blank (mL)

Line 5 of Titrimetric system: Delete the subsection
Blank: 100 mL of water and 4 mL of 3 N hydrochloric
acid

AND
Line 11 of Analysis: Delete the sentence

Perform a blank determination.

AND
Line 13 of Analysis: Change

Result = [(VB) × N × F × 100]/W
to:

Result = [(V × N × F)/W] × 100

AND
Line 15 of Analysis: Delete

B = volume of titrant consumed by the Blank (mL)

CALCIUM SULFATE SPECIFIC TESTS/Loss on Drying <731> USP35–NF30 1724 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1 of Acceptance criteria: Change
NMT 1.5% for the anhydrous form and NMT 19.0%–23.0% for the dihydrate
to:
NMT 1.5% for the anhydrous form and 19.0%–23.0% for the dihydrate

Line 1 of Acceptance criteria: Change
NMT 1.5% for the anhydrous form and NMT 19.0%–23.0% for the dihydrate
to:
NMT 1.5% for the anhydrous form and 19.0%–23.0% for the dihydrate

CAPTOPRIL ORAL SOLUTION Assay USP35–NF30 2477 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.
to:
Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas.

Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.

to:
Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas.

CAPTOPRIL ORAL SUSPENSION Assay USP35–NF30 2477 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.
to:
Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas.

Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.

to:
Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas.

Carisoprodol Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP35–NF30 5921 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5: At end of USP Reference Standards, add
USP Meprobamate RS

Line 5: At end of USP Reference Standards, add
USP Meprobamate RS

Cefepime for Injection IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine Second Supplement to USP35–NF30 5925 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Chromatographic system: Change
Column: 4.0-mm x 25-cm; 5-µm packing L##1
to:
Column: 4.0-mm x 25-cm; 5-µm packing L76
AND
Delete corresponding footnote: Available as Metrosep C4-250.

Line 5 of Chromatographic system: Change
Column: 4.0-mm x 25-cm; 5-µm packing L##1
to:
Column: 4.0-mm x 25-cm; 5-µm packing L76
AND
Delete corresponding footnote: Available as Metrosep C4-250.

Cefepime Hydrochloride IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine Second Supplement to USP35–NF30 5923 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Chromatographic system: Change
Column: 4.0-mm x 25-cm; 5-µm packing L##1
to:
Column: 4.0-mm x 25-cm; 5-µm packing L76
AND
Delete corresponding footnote: "Available as Metrosep C4-250."

Line 5 of Chromatographic system: Change
Column: 4.0-mm x 25-cm; 5-µm packing L##1
to:
Column: 4.0-mm x 25-cm; 5-µm packing L76
AND
Delete corresponding footnote: "Available as Metrosep C4-250."

CHLOROPHYLLIN COPPER COMPLEX SODIUM SPECIFIC TESTS/Loss on Drying <231> USP35–NF30 2628 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1: Change
150°
to:
105°

Line 1: Change
150°

to:

105°

CLONAZEPAM ORAL SUSPENSION ASSAY/Procedure USP36–NF31 3053 01-Apr-2013 USP37–NF32 USP37–NF32
Line 6 of Sample solution: Change
Pipet 2.5 mL of the Sample solution
to:
Pipet 2.5 mL of the sample

Line 6 of Sample solution: Change
Pipet 2.5 mL of the Sample solution
to:
Pipet 2.5 mL of the sample

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM ASSAY/Procedure USP36–NF31 3075 01-Apr-2013 USP37–NF32 USP37–NF32
Line 3 of Betamethasone dipropionate stock solution: Change
J being the ratio (in mg/g) of betamethasone to clotrimazole in the Cream
to:
J being the ratio of the labeled amount of betamethasone (in mg/g) to the labeled amount of clotrimazole (in mg/g) in the Cream

Line 3 of Betamethasone dipropionate stock solution: Change
J being the ratio (in mg/g) of betamethasone to clotrimazole in the Cream

to:
J being the ratio of the labeled amount of betamethasone (in mg/g) to the labeled amount of clotrimazole (in mg/g) in the Cream

Cod Liver Oil ASSAY/Vitamin D USP35–NF30 2756 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Aqueous potassium hydroxide solution: Change
Dissolve 800 mg of potassium hydroxide in 1000 mL of freshly boiled water, mix, and cool.
to:
Dissolve 800 g of potassium hydroxide in 1000 mL of freshly boiled water, mix, and cool.

Line 1 of Aqueous potassium hydroxide solution: Change
Dissolve 800 mg of potassium hydroxide in 1000 mL of freshly boiled water, mix, and cool.
to:
Dissolve 800 g of potassium hydroxide in 1000 mL of freshly boiled water, mix, and cool.

Compound Undecylenic Acid Ointment Assay for zinc undecylenate USP35–NF30 4978 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 17 of Procedure: Change
AU, AH, and AL
to:
AU, AS1, and AS2

Line 17 of Procedure: Change
AU, AH, and AL
to:
AU, AS1, and AS2

XLS CSV