| Monograph Title | Section |
Source Publication |
Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
|---|---|---|---|---|---|---|---|---|
| <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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| <698> DELIVERABLE VOLUME | ACCEPTANCE CRITERIA/For Multiple-Unit Containers | First Supplement to USP35–NF30 | 5154 | 28-Sep-2012 | 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 |
| DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 3 | First Supplement to USP35–NF30 | 5460 | 28-Sep-2012 | 01-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 solution, and Sample solutions Line 2 of Analysis: Change |
| ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP35–NF30 | 5473 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 4 of Medium: Change
and adjust with 2 N hydrochloric acid or 2 N sodium, if necessary, to a pH to: and adjust with 2 N hydrochloric acid or 2 N sodium hydroxide, if necessary, to a pH Line 4 of Medium: Change |
| ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES | IMPURITIES/Organic Impurities | First Supplement to USP35–NF30 | 5473 | 28-Sep-2012 | 01-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), from the Capsule content, to a 200-mL volumetric flask, add 20 mL of methanol, and shake for 30 s. Line 1 of Sample solution: Change |
| OMEGA-3-ACID ETHYL ESTERS CAPSULES | SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> | First Supplement to USP35–NF30 | 5524 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 2: Change
103 to: 103 cfu/mL AND Line 3: Change 102 to: 102 cfu/mL AND Line 6: Change Salmonella in 10 g. to: Salmonella species in 10 g. Line 2: Change AND AND |
| TACROLIMUS | IMPURITIES/Procedure 2 | First Supplement to USP35–NF30 | 5538 | 28-Sep-2012 | 01-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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone. to: (3S,4R,5S,8R,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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone. Footnote h of Table 3: Change |
| TACROLIMUS CAPSULES | IMPURITIES/Procedure 2 | First Supplement to USP35–NF30 | 5541 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Footnote j of Table 5: 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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone. to: (3S,4R,5S,8R,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-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20, 21(4H,23H)-tetrone. Footnote j of Table 5: Change |
| 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 |
| 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 |
| 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 |
| 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 to: |
| 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 |
| 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 |
| 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 |
| <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 |
| 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 |
| <232> ELEMENTAL IMPURITIES--LIMITS | Drug Substance and Excipients | 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 2: Change
7 to: 10 Row 16 of Column 4 of Table 2: Change |
| <232> ELEMENTAL IMPURITIES—LIMITS | DRUG SUBSTANCE AND EXCIPIENTS | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 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 |
| <232> ELEMENTAL IMPURITIES—LIMITS | ANALYTICAL TESTING | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 01-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 |
Line 6: Change
Pd to: Pb Line 6: Change |
| <232> ELEMENTAL IMPURITIES—LIMITS | DRUG SUBSTANCE AND EXCIPIENTS | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 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 |
| <232> ELEMENTAL IMPURITIES—LIMITS | DRUG PRODUCTS/Large Volume Parenterals | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 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 |
| <233> ELEMENTAL IMPURITIES—PROCEDURES | INTRODUCTION/Definition | Second Supplement to USP35–NF30 | 5634 | 28-Sep-2012 | 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 |
| AZITHROMYCIN FOR INJECTION | IMPURITIES/Limit of Aminoazithromycin, Formamido Analog, Methylformamido Analog, and 3′-De(dimethylamino)-3′-oxoazithromycin | Second Supplement to USP35–NF30 | 5910 | 28-Sep-2012 | 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 |
| AZITHROMYCIN FOR INJECTION | IMPURITIES/Limit of Azithromycin N-Oxide, Desosaminylazithromycin, and N-Demethylazithromycin | Second Supplement to USP35–NF30 | 5910 | 28-Sep-2012 | 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 |
| ATRACURIUM BESYLATE INJECTION | IMPURITIES/Organic Impurities/Acceptance criteria/Table 2 | Second Supplement to USP35–NF30 | 5909 | 29-Mar-2013 | 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 monoacrylate. |
| DULOXETINE DELAYED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Chromatographic system | Second Supplement to USP35–NF30 | 5940 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 1 of Column: Change
4.6-mm x 7.5-cm; 3-µm packing L7 to: 4.6-mm x 7.5-cm; 3- or 3.5-µm packing L7 Line 1 of Column: Change |
| SUMATRIPTAN INJECTION | SPECIFIC TESTS/Osmolality and Osmolarity <785> | Second Supplement to USP35–NF30 | 5996 | 29-Mar-2013 | 01-Apr-2013 | USP37–NF32 | USP37–NF32 |
Line 1: Change
270–330 mOsmol to: 270–330 mOsmol/kg Line 1: 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
01–Nov–2012 through 06–May–2013See all Errata for USP–NF


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