Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
Aminosalicylate Sodium | Limit of m-aminophenol | USP35–NF30 | 2177 | 30-Nov-2012 | 1-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.… Read More |
Dibasic Calcium Phosphate Dihydrate | ASSAY | USP35–NF30 | 2463 | 30-Nov-2012 | 1-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 |
Glimepiride Tablets | PERFORMANCE TESTS/Dissolution/Test 1 | USP35–NF30 | 3335 | 30-Nov-2012 | 1-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:… Read More |
Compound Undecylenic Acid Ointment | Assay for zinc undecylenate | USP35–NF30 | 4978 | 30-Nov-2012 | 1-Dec-2012 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 17 of Procedure: Change AU, AH, and AL to: AU, AS1, and AS2 |
Itraconazole | IMPURITIES/Organic Impurities | First Supplement to USP35–NF30 | 5508 | 30-Nov-2012 | 1-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 |
Olanzapine Tablets | ASSAY/Procedure | Revision Bulletin (Official July 01, 2012) | Online | 30-Nov-2012 | 1-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) |
Polysorbate 80 | SPECIFIC TESTS/Fats and Fixed Oils, Peroxide Value <401> | USP35–NF30 | 1920 | 30-Nov-2012 | 1-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 |
Ampicillin Sodium | SPECIFIC TESTS/pH <791> | USP35–NF30 | 2213 | 30-Nov-2012 | 1-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 |
Anhydrous Dibasic Calcium Phosphate | IMPURITIES/Heavy Metals, Method I <231> | USP35–NF30 | 2464 | 30-Nov-2012 | 1-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. |
Tramadol Hydrochloride Tablets | IMPURITIES/Organic Impurities/Procedure | USP35–NF30 | 4905 | 30-Nov-2012 | 1-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 |
Esomeprazole Magnesium Delayed-Release Capsules | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP35–NF30 | 5473 | 30-Nov-2012 | 1-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. |
Cefepime Hydrochloride | IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine | Second Supplement to USP35–NF30 | 5923 | 30-Nov-2012 | 1-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." |
<81> Antibiotics—Microbial Assays | Turbidimetric Method | USP35–NF30 | 74 | 30-Nov-2012 | 1-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. |
Aminosalicylate Sodium Tablets | Limit of m-aminophenol | USP35–NF30 | 2178 | 30-Nov-2012 | 1-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… Read More |
Dibasic Calcium Phosphate Dihydrate | IMPURITIES/Heavy Metals, Method I <231> | USP35–NF30 | 2463 | 30-Nov-2012 | 1-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. |
Moxifloxacin Ophthalmic Solution | Related compounds/Test 1 | USP35–NF30 | 3960 | 30-Nov-2012 | 1-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. |
<660> Containers—Glass | SPECIFIC TESTS/Hydrolytic Resistance/Method | First Supplement to USP35–NF30 | 5150 | 30-Nov-2012 | 1-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… Read More |
Omega-3-Acid Ethyl Esters Capsules | SPECIFIC TESTS/Microbial Enumeration <61> | First Supplement to USP35–NF30 | 5524 | 30-Nov-2012 | 1-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 |
Olanzapine Tablets | IMPURITIES/Organic Impurities | Revision Bulletin (Official July 01, 2012) | Online | 30-Nov-2012 | 1-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) |
Polysorbate 80 | SPECIFIC TESTS/Fats and Fixed Oils, Saponification Value <401> | USP35–NF30 | 1920 | 30-Nov-2012 | 1-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 |
Budesonide | ASSAY/Procedure | USP35–NF30 | 2394 | 30-Nov-2012 | 1-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% |
Cod Liver Oil | ASSAY/Vitamin D | USP35–NF30 | 2756 | 30-Nov-2012 | 1-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. |
Triclosan | Related compounds | USP35–NF30 | 4939 | 30-Nov-2012 | 1-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) |
Esterified Estrogens Tablets | ASSAY/Procedure | First Supplement to USP35–NF30 | 5485 | 30-Nov-2012 | 1-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… Read More |
Cefepime for Injection | IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine | Second Supplement to USP35–NF30 | 5925 | 30-Nov-2012 | 1-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. |
Polysorbate 80 | SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> | USP35–NF30 | 1920 | 30-Nov-2012 | 1-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 |
Aminosalicylic Acid Tablets | Limit of m-aminophenol | USP35–NF30 | 2179 | 30-Nov-2012 | 1-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… Read More |
Anhydrous Dibasic Calcium Phosphate | ASSAY | USP35–NF30 | 2464 | 30-Nov-2012 | 1-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 |
Metronidazole | ASSAY | USP36–NF31 | 4352 | 30-Nov-2012 | 1-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 |
DESCRIPTION AND SOLUBILITY | Ethylcellulose Dispersion Type B | USP35–NF30 | 1118 | 28-Sep-2012 | 1-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. |
<698> DELIVERABLE VOLUME | ACCEPTANCE CRITERIA/For Multiple-Unit Containers | First Supplement to USP35–NF30 | 5154 | 28-Sep-2012 | 1-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 |
MAGNESIUM STEARATE | IMPURITIES/Chloride and Sulfate, Sulfate <221> | USP35–NF30 | 1847 | 28-Sep-2012 | 1-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%) |
TACROLIMUS | IMPURITIES/Procedure 2 | First Supplement to USP35–NF30 | 5538 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Footnote h of Table 3: Change
(3S,4R,5S,8S,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-… Read More |
SODIUM HYDROXIDE | ASSAY/Procedure | USP35–NF30 | 1955 | 28-Sep-2012 | 1-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 … Read More |
<232> ELEMENTAL IMPURITIES—LIMITS | DRUG PRODUCTS/Large Volume Parenterals | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Row 13 of Column 4 of Table 1: Change 250 to: 10 |
ALPRAZOLAM ORALLY-DISINTEGRATING TABLETS | IMPURITIES/Procedure | USP35–NF30 | 2106 | 28-Sep-2012 | 1-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. |
INDINAVIR SULFATE | OTHER COMPONENTS/Procedure 2: Content of Alcohol | USP35–NF30 | 3489 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 6 of Chromatographic system in the subsection Column: Change
G14 to: G16 |
POVIDONE | IMPURITIES/Limit of Aldehydes | USP35–NF30 | 4379 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 15 of Analysis: Change
Result = 10 × (C/W) × {[(AU2 − AU1) × (AB2 − AB1)]/[(AS2 − AS1) − (AB2… Read More |
VINORELBINE TARTRATE | ASSAY/Procedure | USP35–NF30 | 5027 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 1 of Relative standard deviation in System suitability: Change
NLT 2.0% to: NMT 2.0% |
CALCIUM SULFATE | ASSAY/Procedure | USP35–NF30 | 1724 | 28-Sep-2012 | 1-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… Read More |
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES | IMPURITIES/Organic Impurities | First Supplement to USP35–NF30 | 5473 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 1 of Sample solution: Change
Transfer a portion of the powdered pellets, from the Capsule content, equivalent to 80–90 mg of esomeprazole, to a 200-mL volumetric flask, add 20 mL of methanol, and shake for 30 s. to: Transfer a portion of the powdered pellets (about 80–90 mg… Read More |
POLYSORBATE 20 | SPECIFIC TESTS/Acid Value | USP35–NF30 | 1919 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 1 of Sample: Change
10.0 to: 10.0 g |
<232> ELEMENTAL IMPURITIES—LIMITS | ANALYTICAL TESTING | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 6: Change Pd to: Pb |
ACETAZOLAMIDE FOR INJECTION | ASSAY | USP35–NF30 | 2063 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 19: Change 25C(AU/AS) to: 250C(AU/AS) |
AZITHROMYCIN FOR INJECTION | IMPURITIES/Limit of Azithromycin N-Oxide, Desosaminylazithromycin, and N-Demethylazithromycin | Second Supplement to USP35–NF30 | 5910 | 28-Sep-2012 | 1-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/C… Read More |
FLUTICASONE PROPIONATE | IMPURITIES/Organic Impurities | USP35–NF30 | 3261 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 1 of the Sample solution: Change
2.0 mg/mL to: 0.2 mg/mL |
NAFTIFINE HYDROCHLORIDE GEL | Content of alcohol | USP35–NF30 | 3983 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 4 of Procedure: Change
Calculate the quantity, in mg, of C2H5OH in the portion of Gel taken by the formula: to: Calculate the percentage of C2H5OH in the portion of Gel taken by the formula: |
RIBAVIRIN TABLETS | ASSAY/Procedure | USP35–NF30 | 4544 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 5 of System suitability in subsection Tailing factor:
Change
NLT 2.0 to: NMT 2.0 |
BENTONITE | IDENTIFICATION/A. X-Ray Diffraction <941> | USP35–NF30 | 1705 | 28-Sep-2012 | 1-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. |
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 3 | First Supplement to USP35–NF30 | 5460 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 2 of Analysis: Change
Samples: Acid stage standard solution, Buffer stage standard solution, Acid stage sample solutions, and Buffer stage sample solutions to: Samples: Acid stage standard solution, Buffer stage standard… Read More |