| Monograph Title | Section | Source Publication |
Page Number |
Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
|---|---|---|---|---|---|---|---|---|
| DESCRIPTION AND SOLUBILITY | Ethylcellulose Dispersion Type B | USP35–NF30 | 1118 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Lines 3 and 4: Change
in toluene, in chloroform, and in ethyl acetate; insoluble in water, in glycerin, and in propylene glycol. to: in tetrahydrofuran, and in ethyl acetate; insoluble in water and in chloroform. Lines 3 and 4: Change |
| POWDERED BLACK PEPPER EXTRACT | DEFINITION | USP36–NF31 | 1365 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 5: Change
It contains NLT 90.0% and NMT 110.0% of the labeled amount of piperine. to: It contains NLT 90.0% and NMT 110.0% of the labeled amount of piperine, calculated on the dried basis. Line 5: Change |
| 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 |
| BENTONITE | IDENTIFICATION/A. X-Ray Diffraction <941> | USP35–NF30 | 1705 | 28-Sep-2012 | 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 |
| TRIBASIC CALCIUM PHOSPHATE | IDENTIFICATION/Test A | USP35–NF30 | 1719 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 1 of the Sample solution: Change
Dissolve 100 mg in 5 mL of diluted nitric acid. to: A solution in a slight excess of nitric acid Line 1 of the Sample solution: Change |
| CALCIUM SULFATE | ASSAY/Procedure | USP35–NF30 | 1724 | 28-Sep-2012 | 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 = [(V − B) × 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 |
| CALCIUM SULFATE | SPECIFIC TESTS/Loss on Drying <731> | USP35–NF30 | 1724 | 29-Mar-2013 | 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 |
| MICROCRYSTALLINE CELLULOSE | IDENTIFICATION/B. Procedure | USP35–NF30 | 1746 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
4th formula of Analysis: Change
Result = (95) × [η]c/WS × [(100 − %LOD)/100] to: Result = [(95) × [η]c]/{WS × [(100 − %LOD)/100]} 4th formula of Analysis: Change |
| 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 to: AND |
| 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 |
| 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 |
| MAGNESIUM STEARATE | IMPURITIES/Chloride and Sulfate, Sulfate <221> | USP35–NF30 | 1847 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 3: Change
0.020 N sulfuric acid (1.0%) to: 0.020 M sulfuric acid (1.0%) Line 3: Change |
| METHYL ALCOHOL | ASSAY/Procedure | USP35–NF30 | 1865 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 9 of System suitability: Change
Tailing factor: NLT 1.5 for methyl alcohol, System suitability solution to: Tailing factor: NMT 1.5 for methyl alcohol, System suitability solution Line 9 of System suitability: Change |
| 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 |
| POLYETHYLENE OXIDE | IMPURITIES/Organic Impurities/Procedure: Limit of Free Ethylene Oxide | USP35–NF30 | 1906 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 2 of System suitability: Change
Samples: Standard stock solution and Standard solution C to: Sample: Standard solution C Line 2 of System suitability: Change |
| POLYSORBATE 20 | SPECIFIC TESTS/Acid Value | USP35–NF30 | 1919 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 1 of Sample: Change
10.0 to: 10.0 g Line 1 of Sample: Change |
| 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 Line 6 of Analysis: Change |
| 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 |
| 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 |
| POLYSORBATE 60 | SPECIFIC TESTS/Acid Value | USP35–NF30 | 1920 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 1 of Sample: Change
10.0 to: 10.0 g Line 1 of Sample: Change |
| SODIUM HYDROXIDE | ASSAY/Procedure | USP35–NF30 | 1955 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 10 of Analysis: Change
Result = {[(VS1 − VB) × N × F1]/W} × 100 to: Result = {[(VS2 − VB) × N × F1]/W} × 100 AND Line 11 of Analysis: Change VS1 to: VS2 Line 10 of Analysis: Change |
| TAPIOCA STARCH | Limit of oxidizing substances | USP35–NF30 | 1987 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 8: Change
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodide color. to: Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodine color. Line 8: Change |
| DIETHYL SEBACATE | DEFINITION | USP36–NF31 | 1994 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 2: Change
Diethyl Sebacate consists of the diester of alcohol and sebacic acid. to: Diethyl Sebacate consists of the diester of alcohol (ethanol) and sebacic acid. Line 2: Change |
| TREHALOSE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP35–NF30 | 2007 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 2: Delete
USP Glycerin RS Line 2: Delete |
| ZEIN | IDENTIFICATION/C. SDS-Polyacrylamide Gel Electrophoresis | USP35–NF30 | 2019 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Lines 1 and 2 of the Acceptance criteria: Change
Zein has two major bands: the α band is at 21–25 kDa, and the β band is at 17–18 kDa. to: Zein has two major bands for α-zein at 19–26 kDa. Lines 1 and 2 of the Acceptance criteria: Change |
| HYMETELLOSE | IMPURITIES/Chloride and Sulfate, Chloride <221> | USP36–NF31 | 2044 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Change the subsection title
Standard solution to: Control solution AND Line 4 of Analysis: Change Standard solution to: Control solution AND Line 2 of Acceptance criteria: Change Standard solution to: Control solution Change the subsection title |
| INOSITOL | SPECIFIC TESTS/Conductivity | USP36–NF31 | 2049 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 1 of Sample solution: Change
Transfer 10.0 g of Inositol, weighed and calculated on the dried basis, to a 50-mL volumetric flask, and dissolve in and dilute with water (previously boiled and cooled to room temperature) to volume. to: 0.2 g/mL of Inositol in water (previously boiled and cooled to room temperature). Line 1 of Sample solution: Change |
| ACETAZOLAMIDE FOR INJECTION | ASSAY | USP35–NF30 | 2063 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 19: Change
25C(AU/AS) to: 250C(AU/AS) Line 19: Change |
| ADENOSINE | IDENTIFICATION/Infrared Absorption <197M> | USP35–NF30 | 2079 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 1:
Delete NMT 0.1% Line 1: |
| ALPRAZOLAM ORALLY-DISINTEGRATING TABLETS | IMPURITIES/Procedure | USP35–NF30 | 2106 | 28-Sep-2012 | 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 |
| HYDROGENATED POLYDECENE | ASSAY/Content of Decene Oligomer | USP36–NF31 | 2133 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 3 of System suitability: Change
[Note—The retention time for squalene is about 18 min; the relative retention times for tetradecane, hexadecane, and squalene are about 0.5, 0.6, and 1.0, respectively.] to: [Note—The retention time for squalane is about 18 min; the relative retention times for tetradecane, hexadecane, and squalane are about 0.5, 0.6, and 1.0, respectively.] Line 3 of System suitability: Change |
| AMANTADINE HYDROCHLORIDE CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Test 2 | USP35–NF30 | 2153 | 31-Jan-2013 | 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 |
| POLYVINYL ACETATE PHTHALATE | IMPURITIES/Free Phthalic Acid | USP36–NF31 | 2168 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 1 of Sample solution: Change
6 mg/mL of polyvinyl acetate to: 6 mg/mL of polyvinyl acetate phthalate Line 1 of Sample solution: Change |
| 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 |
| 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 |
| 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: Line 1 of Test solution: Change |
| PROPYLENE GLYCOL MONOLAURATE | IMPURITIES/Limit of Propylene Glycol | USP36–NF31 | 2180 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 8 of Analysis: Change
Calculate the percentage of free propylene glycol in the portion of Propylene Glycol Monocaprylate taken: to: Calculate the percentage of free propylene glycol in the portion of Propylene Glycol Monolaurate taken: Line 8 of Analysis: Change |
| AMOXICILLIN TABLETS | PERFORMANCE TESTS | USP35–NF30 | 2202 | 28-Sep-2012 | 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 |
| 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 |
| ATROPINE SULFATE TABLETS | Assay | USP35–NF30 | 2272 | 29-Mar-2013 | 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 |
| AZITHROMYCIN | IMPURITIES/Organic Impurities/Procedure 2 | USP35–NF30 | 2279 | 29-Mar-2013 | 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 |
| BETAMETHASONE ORAL SOLUTION | Identification/A: | USP35–NF30 | 2336 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 1: Change
A: to: A: Thin-Layer Chromatographic Identification Test <201>— Line 1: Change |
| BRINZOLAMIDE | Related compounds/Test 2 | USP35–NF30 | 2385 | 29-Mar-2013 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| CAPTOPRIL ORAL SOLUTION | Assay | USP35–NF30 | 2477 | 31-Jan-2013 | 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 |
| CAPTOPRIL ORAL SUSPENSION | Assay | USP35–NF30 | 2477 | 31-Jan-2013 | 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 |
01–Nov–2012 through 06–May–2013See all Errata for USP–NF


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