How to Use the USP–NF Errata Table

  • Searching: Type keyword in search field at top of page. Search by all or part of a monograph title. For searches using multiple criteria, you will find items that match each of the specified criteria unless quotation marks are used.
    • For example, a search on Aminosalicylic Acid Tablets will result in anything that contains “Aminosalicyclic” OR “Acid” OR “Tablets”
    • A search for “Aminosalicylic Acid Tablets” will result in anything that specifically contains “Aminosalicylic Acid Tablets”
  • Sorting: Click on any blue column header title to sort alphabetically or chronologically in ascending or descending order. Note: the page load column is sorted alphabetically so that a number is ordered by first digit vs. by the actual number; thus, numbers will not always be in order.
    • For example, page 2178 will come before page 74 on a page sort.
  • Downloading: You can download the Errata table in Comma-separated Value (.csv) or Excel format (.xls). The download will include all Errata from the database.
  • Printing: The table will print the view of the data as it has been filtered or sorted. To print a table of all Errata in the database, clear any keyword searches you have applied and select “Show: All”.
Monograph Title Section Source Publication Page Number Errata Post Date Errata Official Date Target Errata Print Publicationsort icon Target Online Fix Publication Description
Polysorbate 80 SPECIFIC TESTS/Fats and Fixed Oils, Saponification Value <401> USP35–NF30 1920 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Analysis: Change
0.5 N alcoholic potassium hydroxide
to:
0.5 N alcoholic potassium hydroxide VS

Line 6 of Analysis: Change
0.5 N hydrochloric acid
to:
0.5 N hydrochloric acid VS

Line 3 of Analysis: Change
0.5 N alcoholic potassium hydroxide
to:
0.5 N alcoholic potassium hydroxide VS

Line 6 of Analysis: Change
0.5 N hydrochloric acid

to:
0.5 N hydrochloric acid VS
Aminosalicylate Sodium Limit of m-aminophenol USP35–NF30 2177 30-Nov-2012 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 30-Nov-2012 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 30-Nov-2012 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
Moxifloxacin Ophthalmic Solution Related compounds/Test 1 USP35–NF30 3960 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 4 of Chromatographic system: Delete
The flow rate is about 0.5 mL per minute.

Line 4 of Chromatographic system: Delete
The flow rate is about 0.5 mL per minute.
Metronidazole ASSAY USP36–NF31 4352 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 8 of Chromatogaphic system: Add new subsection after Injection volume:
Run time: Twice the retention time of metronidazole

Line 8 of Chromatogaphic system: Add new subsection after Injection volume:
Run time: Twice the retention time of metronidazole
Tramadol Hydrochloride Tablets IMPURITIES/Organic Impurities/Procedure USP35–NF30 4905 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (1/F) × 0.1
to:
Result = (rU/rS) × (CS/CU) × (1/F) × 100

Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (1/F) × 0.1
to:
Result = (rU/rS) × (CS/CU) × (1/F) × 100
Triclosan Related compounds USP35–NF30 4939 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Procedure: Change
Inject a volume (about 0.5 µL)
to:
Inject a volume (about 2.0 µL)

Line 1 of Procedure: Change
Inject a volume (about 0.5 µL)
to:
Inject a volume (about 2.0 µL)
Compound Undecylenic Acid Ointment Assay for zinc undecylenate USP35–NF30 4978 30-Nov-2012 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
<660> Containers—Glass SPECIFIC TESTS/Hydrolytic Resistance/Method First Supplement to USP35–NF30 5150 30-Nov-2012 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.
Esomeprazole Magnesium Delayed-Release Capsules ASSAY/Procedure First Supplement to USP35–NF30 5473 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Standard solution: Change
Transfer 10 mg of USP Omeprazole RS to a 250-mL volumetric flask, and dissolve in about 10 mL of methanol.
to:
Transfer 10 mg of USP Omeprazole RS to a 250-mL volumetric flask, and dissolve in about 10 mL of alcohol.

Line 1 of Standard solution: Change
Transfer 10 mg of USP Omeprazole RS to a 250-mL volumetric flask, and dissolve in about 10 mL of methanol.
to:
Transfer 10 mg of USP Omeprazole RS to a 250-mL volumetric flask, and dissolve in about 10 mL of alcohol.
Esomeprazole Magnesium Delayed-Release Capsules PERFORMANCE TESTS/Dissolution <711> First Supplement to USP35–NF30 5473 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Change
Buffer, Diluent, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.

Change
Buffer, Diluent, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.

to:
Buffer, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.
Esterified Estrogens Tablets ASSAY/Procedure First Supplement to USP35–NF30 5485 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Analysis: Change
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Conjugated Estrogens taken:
to:
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Tablets taken:

Line 3 of Analysis: Change
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Conjugated Estrogens taken:

to:
Separately calculate the percentage of the labeled amount of sodium estrone sulfate and sodium equilin sulfate in the portion of Tablets taken:
Itraconazole IMPURITIES/Organic Impurities First Supplement to USP35–NF30 5508 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Standard solution: Change
1.0 µg/mL of USP Itraconazole RS in Diluent
to:
10.0 µg/mL of USP Itraconazole RS in Diluent

Line 1 of Standard solution: Change
1.0 µg/mL of USP Itraconazole RS in Diluent
to:
10.0 µg/mL of USP Itraconazole RS in Diluent
Omega-3-Acid Ethyl Esters Capsules SPECIFIC TESTS/Microbial Enumeration <61> First Supplement to USP35–NF30 5524 30-Nov-2012 01-Dec-2012 USP37–NF32 First Supplement to USP36–NF31
Line 2: Change
103
to:
103 cfu/g
AND
Line 3: Change
102
to:
102 cfu/g

Line 2: Change
103
to:
103 cfu/g
AND
Line 3: Change
102
to:
102 cfu/g
Ampicillin Sodium SPECIFIC TESTS/pH <791> USP35–NF30 2213 30-Nov-2012 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
Budesonide ASSAY/Procedure USP35–NF30 2394 30-Nov-2012 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%
Dibasic Calcium Phosphate Dihydrate ASSAY USP35–NF30 2463 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 14 of Analysis: Change
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution

Line 14 of Analysis: Change
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution
Dibasic Calcium Phosphate Dihydrate IMPURITIES/Heavy Metals, Method I <231> USP35–NF30 2463 30-Nov-2012 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.
Anhydrous Dibasic Calcium Phosphate ASSAY USP35–NF30 2464 30-Nov-2012 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 30-Nov-2012 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.
Cod Liver Oil ASSAY/Vitamin D USP35–NF30 2756 30-Nov-2012 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.
Glimepiride Tablets PERFORMANCE TESTS/Dissolution/Test 1 USP35–NF30 3335 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Analysis: Change
Result = (rU/rS) × (CS/L) × V × 100
to:
Result = (rU/rS) × (CS/L) × V × D x 100
AND after Line 8 of Analysis: Add
D = dilution factor of the Sample solution

Line 3 of Analysis: Change

Result = (rU/rS) × (CS/L) × V × 100

to:
Result = (rU/rS) × (CS/L) × V × D x 100

AND after Line 8 of Analysis: Add
D = dilution factor of the Sample solution
Olanzapine Tablets ASSAY/Procedure Revision Bulletin (Official July 01, 2012) Online 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 10 of Analysis: Change
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)

Line 10 of Analysis: Change
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)
Olanzapine Tablets IMPURITIES/Organic Impurities Revision Bulletin (Official July 01, 2012) Online 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 11 of Analysis: Change
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)

Line 11 of Analysis: Change
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)
Olanzapine Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official July 01, 2012) Online 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Lines 3 and 6: Change
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
to:
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
C12H9N3O2S 259.28
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
C12H10N2OS 230.29

Lines 3 and 6: Change
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.

USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.

to:
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.

C12H9N3O2S 259.28
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.

 Read More
<81> Antibiotics—Microbial Assays Turbidimetric Method USP35–NF30 74 30-Nov-2012 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.
Polysorbate 80 SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP35–NF30 1920 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 13 of Analysis: Change
0.5 N alcoholic potassium hydroxide
to:
0.5 N alcoholic potassium hydroxide VS

Line 13 of Analysis: Change
0.5 N alcoholic potassium hydroxide
to:
0.5 N alcoholic potassium hydroxide VS
Polysorbate 80 SPECIFIC TESTS/Fats and Fixed Oils, Peroxide Value <401> USP35–NF30 1920 30-Nov-2012 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Analysis: Change
0.01 M sodium thiosulfate
to:
0.01 M sodium thiosulfate VS

Line 5 of Analysis: Change
0.01 M sodium thiosulfate
to:
0.01 M sodium thiosulfate VS
Carisoprodol Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP35–NF30 5921 30-Nov-2012 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 Hydrochloride IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine Second Supplement to USP35–NF30 5923 30-Nov-2012 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 for Injection IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine Second Supplement to USP35–NF30 5925 30-Nov-2012 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.
<621> CHROMATOGRAPHY SYSTEM SUITABILITY/Stationary Phase USP35–NF30 258 31-Jan-2013 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
<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 31-Jan-2013 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
ACESULFAME POTASSIUM IMPURITIES/Limit of Fluoride USP35–NF30 1680 31-Jan-2013 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)
GLYCERYL BEHENATE IMPURITIES USP35–NF30 1811 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 34 of Content of 1-Monoglycerides/Analysis: Change
F = equivalency factor of glyceryl monobehenate, 207.3 mg/mEq
to:
F = equivalency factor of glyceryl monobehenate, 0.2073 g/mEq
AND
Line 19 of Limit of Free Glycerin/Analysis: Change
F = equivalency factor of glycerin, 23.0 mg/mEq
to:
F = equivalency factor of glycerin, 0.023 g/mEq

Line 34 of Content of 1-Monoglycerides/Analysis: Change
F = equivalency factor of glyceryl monobehenate, 207.3 mg/mEq

to:
F = equivalency factor of glyceryl monobehenate, 0.2073 g/mEq

AND
Line 19 of Limit of Free Glycerin/Analysis: Change
F = equivalency factor of glycerin, 23.0 mg/mEq
to:
F = equivalency factor of glycerin, 0.023 g/mEq
GLYCERYL MONOOLEATE SPECIFIC TESTS/Fats and Fixed Oils, Fatty Acid Composition <401> USP35–NF30 1814 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Column 3 of Table 1: Change in Row 1
Percentage, NMT (%)
to:
Percentage (%)
Change in Row 2
12.0
to:
NMT 12.0
Change in Row 3
6.0
to:
NMT 6.0
Change in Row 4
60.0
to:
NLT 60.0
Change in Row 5
35.0
to:
NMT 35.0
Change in Row 6
2.0
to:
NMT 2.0
Change in Row 7
2.0
to:
NMT 2.0
Change in Row 8
2.0
to:
NMT 2.0

Column 3 of Table 1: Change in Row 1
Percentage, NMT (%)
to:
Percentage (%)
Change in Row 2
12.0
to:
NMT 12.0
Change in Row 3
6.0
to:
NMT 6.0
Change in Row 4
60.0
to:
NLT 60.0
Change in Row 5
35.0
to:
NMT 35.0
Change in Row 6
2.0
to:
NMT 2.0
Change in Row 7
2.0
to:
NMT 2.0
Change in Row 8
2.0
to:
NMT 2.0
ONDANSETRON INJECTION USP Reference Standards USP35–NF30 4120 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 7: Delete
USP Ondansetron Related Compound B RS
6,6´-Methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)-methyl]-4H-carbazol-4-one.

Line 7: Delete
USP Ondansetron Related Compound B RS

6,6´-Methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)-methyl]-4H-carbazol-4-one.
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 USP35–NF30 4167 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 3 of Working standard solution: Change
or transfer 10 mL for Tablets labeled to contain 10 mg, to a 100-mL volumetric flask.
to:
transfer 10 mL for Tablets labeled to contain 10 mg, or transfer 15 mL for Tablets labeled to contain 15 mg to a 100-mL volumetric flask.

Line 3 of Working standard solution: Change
or transfer 10 mL for Tablets labeled to contain 10 mg, to a 100-mL volumetric flask.
to:
transfer 10 mL for Tablets labeled to contain 10 mg, or transfer 15 mL for Tablets labeled to contain 15 mg to a 100-mL volumetric flask.
PHENYLALANINE IMPURITIES USP35–NF30 4296 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Heavy Metals, Method I <231>: Change
Method I
to:
Method II

Line 1 of Heavy Metals, Method I <231>: Change
Method I
to:
Method II
TRIAZOLAM TABLETS Assay USP35–NF30 4936 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 2: Change
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Triazolam.
to:
Mobile phase—Prepare a filtered and degassed mixture of acetonitrile, chloroform, butyl alcohol, water, and glacial acetic acid (850:80:50:20:0.5). Make adjustments if necessary (see System Suitability under Chromatography <621>).
AND
After the Assay preparation subsection: Add a new subsection
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 30-cm column that contains packing L3. The flow rate is about 2.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the relative retention times are 1 for triazolam and about 1.4 for the internal standard, the resolution, R, between the internal standard and triazolam is not less than 2.0, and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Line 4 of Procedure: Change
Calculate the quantity, in mg, of C17H12Cl2N4 in the portion of Triazolam taken by the formula:
to:
Calculate the quantity, in mg, of C17H12Cl2N4 in the portion of Tablets taken by the formula:
AND
Line 9 of Procedure: Change
RU and RS are the ratios of the internal standard peak area to the triazolam peak area obtained from the Assay preparation and the Standard preparation, respectively.
to:
RU and RS are the ratios of the triazolam peak area to the internal standard peak area obtained from the Assay preparation and the Standard preparation, respectively.

Line 2: Change
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Triazolam.
to:
Mobile phase—Prepare a filtered and degassed mixture of acetonitrile, chloroform, butyl alcohol, water, and glacial acetic acid (850:80:50:20:0.5). Make adjustments if necessary (see System Suitability under Chromatography <621>).
AND
After the Assay preparation subsection: Add a new subsection

 Read More
VINCRISTINE SULFATE IMPURITIES/Organic Impurities USP35–NF30 5022 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Analysis: Change
Result = [rUA/(ΣrUA + 25rUB)] × 100
to:
Result = [rUA/(ΣrUA + 30rUB)] × 100
AND
Change line 12 of Analysis:
Result = [ΣrUA/(ΣrUA + 25rUB)] × 100
to:
Result = [ΣrUA/(ΣrUA + 30rUB)] × 100

Line 5 of Analysis: Change
Result = [rUA/(ΣrUA + 25rUB)] × 100
to:
Result = [rUA/(ΣrUA + 30rUB)] × 100
AND
Change line 12 of Analysis:
Result = [ΣrUA/(ΣrUA + 25rUB)] × 100
to:
Result = [ΣrUA/(ΣrUA + 30rUB)] × 100
ZINC GLUCONATE IMPURITIES/Limit of Cadmium USP35–NF30 5070 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 22 of Analysis: Change
W = weight of Calcium Gluconate taken to prepare Sample solution A (g)
to:
W = weight of Zinc Gluconate taken to prepare Sample solution A (g)

Line 22 of Analysis: Change
W = weight of Calcium Gluconate taken to prepare Sample solution A (g)
to:
W = weight of Zinc Gluconate taken to prepare Sample solution A (g)
ALLANTOIN IDENTIFICATION First Supplement to USP35–NF30 5429 31-Jan-2013 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.
<232> ELEMENTAL IMPURITIES--LIMITS Drug Products/Large Volume Parenterals Second Supplement to USP35–NF30 5633 31-Jan-2013 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
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 31-Jan-2013 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
ADAPALENE IMPURITIES/Residual Solvent: Limit of Triethylamine Revision Bulletin (Official December 01, 2012) Online 31-Jan-2013 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
TACROLIMUS ORAL SUSPENSION ASSAY/Chromatographic system USP36–NF31 5261 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
After line 1 of Column: Add a new section
Column temperature: 70°

After line 1 of Column: Add a new section
Column temperature: 70°
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE Assay USP35–NF30 1822 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 2: Change
Hypromellose 2906, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose 2906 throughout.
to:
Hypromellose, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose throughout.

Line 2: Change
Hypromellose 2906, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose 2906 throughout.

to:
Hypromellose, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose throughout.
MYRISTYL ALCOHOL SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP35–NF30 1873 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 7 of Analysis: Change
Result = [(VU − VB) × F]/W
VU = volume of 1 N sodium hydroxide consumed by the Sample (mL)
VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)
to:
Result = [(VB − VU) × F]/W
VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)
VU = volume of 1 N sodium hydroxide consumed by the Sample (mL)

Line 7 of Analysis: Change
Result = [(VU − VB) × F]/W
VU = volume of 1 N sodium hydroxide consumed by the Sample (mL)
VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)
to:
Result = [(VB − VU) × F]/W
VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)
VU = volume of 1 N sodium hydroxide consumed by the Sample (mL)
XLS CSV