Monograph Title | Section | Source Publication | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication Sort ascending | Description |
---|---|---|---|---|---|---|---|---|
COSYNTROPIN | SPECIFIC TESTS/UV Absorption Spectrophotometry | USP38–NF33 | 2958 | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 1 of Sample solution: Change hydrochloride to: hydrochloric acid |
CEFAZOLIN FOR INJECTION | ASSAY/Procedure | USP38–NF33 | 2652 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 7 of Analysis: Change Result = (RU/RS) × (CS/CU) × P × F × 100 to: Result = (RU/RS) × (CS… Read More |
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP38–NF33 | 4348 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 3 of USP Methylphenidate Related Compound A RS: Change 255.75 to: 255.74 |
SORBITOL SORBITAN SOLUTION | SPECIFIC TESTS | USP37–NF32 | 6197 | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 1 of pH <791>: Change 4.0–7.0, in a 14% solution of Sorbitol Sorbitan Solution in carbon dioxide-free water to: 4.0–7.0, in a 14% (w/w) solution of Sorbitol Sorbitan Solution in carbon dioxide-free water |
<232> ELEMENTAL IMPURITIES--LIMITS | DRUG SUBSTANCE AND EXCIPIENTS/Table 2 | Second Supplement to USP38–NF33 | 7594 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 1 of Row 1 of Column 2: Change (g/g) to: (µg/g) AND Line 1 of Row 1 of Column 3: Change (g/g) to: (µg/g) AND Line 1 of Row 1 of Column 4: Change (g/g) to: (µg/g) |
QUETIAPINE FUMARATE | IMPURITIES/Organic Impurities | USP38–NF33 | 5102 | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 2 of Peak identification solution: Change USP Quetiapine Fumarate Related Compound B RS to: USP Quetiapine Related Compound B RS AND Line 3 of Peak identification solution: Change USP Quetiapine Fumarate Related Compound G RS to: USP Quetiapine Related… Read More |
CEFIXIME | CHEMICAL INFORMATION | USP38–NF33 | 2665 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 9: Change [79350-37-1]. to: [125110-14-7]. Anhydrous [79350-37-1]. |
PROTAMINE SULFATE | SPECIFIC TESTS/pH <791> | USP38–NF33 | 5069 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Delete the test for pH |
TREHALOSE | IMPURITIES/Heavy Metals, Method I <231> | USP37–NF32 | 6247 | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 1 of Monitor preparation: Change Prepare with 2.5 mL of Standard Lead Solution. to: Prepare with 2.0 mL of Standard Lead Solution. |
CROMOLYN SODIUM OPHTHALMIC SOLUTION | Related compounds | USP38–NF33 | 2962 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 1: Change It meets the requirements of the test for Related compounds under Cromolyn Sodium Inhalation Solution, “Ophthalmic Solution” being read in place of “Inhalation Solution.” to: Apply 10-µL portions of Ophthalmic Solution and Standard solutions of USP Cromolyn… Read More |
QUETIAPINE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 3 | USP38–NF33 | 5104 | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 7 of Instrumental conditions: Change 10 0mg, to: 100 mg, AND Line 5 of Tolerances: Change For Tablets labeled to contain 100 mg, 200 mg, 300 mg, or 400 mg: to: For Tablets labeled to contain 50 mg, 100 mg, 200 mg, 300 mg, or 400 mg: |
CEFOTAXIME FOR INJECTION | ASSAY/Procedure | USP38–NF33 | 2678 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 10 of the Calculate statement in the Analysis: Change CU = nominal concentration of cefotaxime sodium in Sample solution 1, 2, 3, or 4 (mg/mL) to: CU = nominal concentration of cefotaxime in Sample solution 1… Read More |
QUININE SULFATE | CHEMICAL INFORMATION | USP38–NF33 | 5122 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 4: Change dihydrate [6119-70-6]. to: dihydrate [207671-44-1]. |
BUTORPHANOL TARTRATE NASAL SOLUTION | IMPURITIES/Organic Impurities | First Supplement to USP37–NF32 | 6596 | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Row 3 of Column 1 of Table 1: Change 6-Butorphanol to: Δ6-Butorphanol |
CROMOLYN SODIUM OPHTHALMIC SOLUTION | Assay | USP38–NF33 | 2962 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 1 of Procedure: Change Proceed as directed for Procedure in the Assay under Cromolyn Sodium Inhalation Solution. to: Concomitantly determine the absorbances of the Standard preparation and the Assay preparation in 1-cm cells at the… Read More |
<1047> GENE THERAPY PRODUCTS | REGULATIONS AND STANDARDS | USP38–NF33 | 883 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 8: Delete and, in particular, www.fda.gov/cber/publications.htm |
CISATRACURIUM BESYLATE | SPECIFIC TESTS/Water Determination, Method Ia <921> | USP38–NF33 | 2828 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 1: Change Method Ia to: Method Ic |
ORAL REHYDRATION SALTS | ASSAY/Dextrose | USP38–NF33 | 5145 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 10 of Analysis: Change A = 100 mm divided by the length of the polarimeter tube (mm) to: A = 100 divided by the length of the polarimeter tube (dm) AND Line 21 of Analysis: Change A = 100 mm divided by the length of the polarimeter tube (mm… Read More |
RIVASTIGMINE TARTRATE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP37–NF32 | Online | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 2 of USP Rivastigmine Related Compound A RS: Change Di-p-toluoyl-D-(+)-tartaric acid monohydrate. C20H20O9 404.37 to: (+)-Di-(p-toluoyl)-D-tartaric acid. C20H18O8 386.35 |
ISONIAZID | IMPURITIES/Organic Impurities | First Supplement to USP38–NF33 | 7413 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Row 2 of Column 1 of Table 1:Change Isoniacin to Isoniacina AND Row 5 of Column 1 of Table 1: Change Picolinohydrazide to Picolinohydrazideb AND Row 6 of Column 1 of Table 1: Change Isonicotinonitrile to: … Read More |
<1047> GENE THERAPY PRODUCTS | APPENDIX | USP38–NF33 | 883 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 8 of National and International Regulatory Documents: Delete (http://www4.od.nih.gov/oba/guidelines.html) |
CUPRIC SULFATE | ASSAY/Procedure/Titrimetric system | USP38–NF33 | 2965 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 1 of Endpoint detection: Change Potentiometric to: Visual |
AMINOBENZOIC ACID | IMPURITIES/Organic Impurities | USP37–NF32 | 1730 | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Add the subsection: Standard stock solution: 0.25 mg/mL each of USP Benzocaine RS and 4-nitrobenzoic acid in methanol AND Line 2 of Standard solution: Change in Mobile phase to: in Mobile phase, from the Standard stock solution |
BANABA LEAF POWDER | DEFINITION | USP38–NF33 | 5903 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 1: Change dried leaves of Lagerstroemia speciosa (L.) Pers. (Fam. Lythraceae) by extraction with hydroalcoholic mixtures. to: dried leaves of Lagerstroemia speciosa (L.) Pers. (Fam. Lythraceae) reduced to powder or very fine powder. |
FERRIC AMMONIUM CITRATE | Mercury | Second Supplement to USP37–NF32 | Online | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 1 of Procedure: Change Add 5 mL of stannous chloride solution (1 in 10) to each solution to: Add 5 mL of Stannous Chloride Solution to each solution |
<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS | SECTION 2: QUALITY, ORGANIZATION, AND DOCUMENTATION/2.8 Contract Activities | USP38–NF33 | 1396 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Footnote 2: Change http://whqlibdoc.who.int/trs/WHO_TRS_917_annex2.pdf (Accessed June 30, 2011) to: … Read More |
FEXOFENADINE HYDROCHLORIDE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 1 | USP38–NF33 | 3487 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 4 of System suitability solution: Change [Note—A small amount of acetic acid, to: [Note—A small amount of glacial acetic acid, |
BETAMETHASONE DIPROPIONATE | ASSAY/Procedure | USP37–NF32 | 1961 | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 2 of Sample solution: Change 5.0 mL each of the Internal standard solution and the Standard stock solution to: 5.0 mL each of the Internal standard solution and the Sample stock solution |
SODIUM CETOSTEARYL SULFATE | IMPURITIES/Limit of Free Cetostearyl Alcohol | USP38–NF33 | 6868 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 5 of Analysis: Change Result = 100(rA + rB) × WIS × (SA(corr) × W) to: Result = 100(rA + rB) × WIS/(SA(corr) × W) … Read More |
MINERAL OIL | SPECIFIC TESTS/Readily Carbonizable Substances Test <271> | Second Supplement to USP37–NF32 | Online | 27-Mar-2015 | 1-Apr-2015 | USP39–NF34 | USP39–NF34 | Line 1 of Acceptance criteria: Change The Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution. to: The oil portion of the Sample may turn hazy, but it… Read More |
<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS | SECTION 4: RETURNED GOODS, DISPATCH, TRANSPORT, IMPORTATION, ADULTERATION, AND TRACEABILITY/4.7 Importation | USP38–NF33 | 1396 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Footnote 11: Delete http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077691.htm (Accessed June 6,… Read More |
OXCARBAZEPINE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 2 | USP37–NF32 | 4119 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 4 of Standard solution: Change µg/mL, where L is the label claim in mg/Tablet. to: mg/mL, where L is the label claim in mg/Tablet. |
DESCRIPTION AND SOLUBILITY | Racemethionine | USP37–NF32 | 1523 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 6: Change flavors and frangrance. to: flavors and fragrance. |
ATROPINE SULFATE | IMPURITIES | First Supplement to USP37–NF32 | 6591 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Row 6 of Column 1 of Table 2: Change Hyoscyamine related compound Ae to: Hyoscyamine related compound A AND Delete footnote e AND Reletter the following footnotes in both the table and footnote definitions: f to e g to f |
SUFENTANIL CITRATE INJECTION | ASSAY/Procedure | USP37–NF32 | 4759 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 11 of Analysis: Change sufentanil to: sufentanil citrate |
CODEINE PHOSPHATE ORAL SOLUTION | ASSAY/Procedure | USP37–NF32 | 2451 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 6 of Analysis: Change Result = (RU/RS) × (CS/CU) × 100 to: Result = (RU/RS) × (CS/CU) × (Mr1/Mr2… Read More |
ATROPINE SULFATE INJECTION | ASSAY/Procedure | First Supplement to USP36–NF31 | 5950 | 28-Mar-2014 | 1-Apr-2014 | USP38–NF33 | USP38–NF33 | Line 1 of Buffer: Change Dissolve 4.1 g of sodium acetate and to: Dissolve 4.1 g of anhydrous sodium acetate and |
ECHINACEA PALLIDA | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP37–NF32 | 5353 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 5: Change USP Powdered Echinacea purpurea Extract RS to: USP Powdered Echinacea pallida Extract RS |
STRONG IODINE SOLUTION | ASSAY | USP37–NF32 | 3354 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 1 of Acceptance criteria in Iodine: Change of iodine (I) to: of iodine (I) in each 100 mL AND Line 1 of Acceptance criteria in Potassium Iodide: Change potassium iodide (KI) to: potassium iodide (KI) in each 100 mL |
PROGESTERONE VAGINAL SUPPOSITORIES | ASSAY/Suppositories in Fatty Acid Base | USP37–NF32 | 4430 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 1 of System suitability solution: Change Transfer 2.0 mL of System suitability stock solution A and System suitability stock solution B to: Transfer 2.0 mL of each System suitability stock solution A and System suitability stock solution B AND… Read More |
DESCRIPTION AND SOLUBILITY | Sodium Acetate | USP37–NF32 | 1525 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 7: Change transfer liquid. to: transfer ligand. |
CIPROFLOXACIN EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 2 | First Supplement to USP37–NF32 | 6619 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 1 of Standard solution: Change 0.56 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium to: 0.62 mg/mL of USP Ciprofloxacin Hydrochloride RS in Medium AND Line 8 of Analysis: Change CS = concentration of ciprofloxacin in the… Read More |
<81> ANTIBIOTICS—MICROBIAL ASSAYS | Turbidimetric Method | USP36–NF31 | 76 | 28-Mar-2014 | 1-Apr-2014 | USP38–NF33 | USP38–NF33 | Line 9 of Paragraph 2 of Analysis: Change or a water bath maintained at the temperature specified in Table 8 and for the time specified in Table 11. to: or a water bath maintained at 36.0° –37.5° for the time specified in Table 11. |
SULFACETAMIDE SODIUM OPHTHALMIC OINTMENT | ASSAY/Procedure | USP37–NF32 | 4765 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 1 of Sample solution: Change USP Sulfacetamide Sodium RS to: sulfacetamide sodium |
DAPSONE TABLETS | IDENTIFICATION/B. Ultraviolet Absorption <197U> | USP37–NF32 | 2514 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 1 of Sample solution: Delete Nominally 0.01 μg/mL prepared as follows. |
BUTYLPARABEN | IMPURITIES/Related Substances/Chromatographic system | Second Supplement to USP36–NF31 | 6551 | 28-Mar-2014 | 1-Apr-2014 | USP38–NF33 | USP38–NF33 | After the Column section: Add Column temperature: 35° |
POWDERED ECHINACEA PALLIDA | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP37–NF32 | 5356 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 5: Change USP Powdered Echinacea purpurea Extract RS to: USP Powdered Echinacea pallida Extract RS |
LAMIVUDINE AND ZIDOVUDINE TABLETS | IMPURITIES/Organic Impurities | USP37–NF32 | 3484 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 12 of Analysis: Change unidentified impurity to: unspecified impurity AND Line 19 of Analysis: Change unidentified impurities to: unspecified impurities |
PSEUDOEPHEDRINE HYDROCHLORIDE, CARBINOXAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | Microbial enumeration tests <61> and Tests for specified microorganisms <62> | USP37–NF32 | 4486 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 3: Change does not exceed 100 per g, the total combined molds and yeasts count does not exceed 10 per g, to: does not exceed 102 cfu/g, the total combined molds and yeasts count does not exceed 101 cfu/g, |
ACETAMINOPHEN SUPPOSITORIES | ASSAY/Procedure | USP37–NF32 | 1567 | 30-May-2014 | 1-Jun-2014 | USP38–NF33 | USP38–NF33 | Line 6 of Sample stock solution: Change add 30 mL of hexane, to: add 30 mL of solvent hexane, AND Line 10 of Sample stock solution: Change wash the hexane to: wash the solvent hexane |