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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
MINOCYCLINE FOR INJECTION IMPURITIES USP37–NF32 3843 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 6 of Limit of Epiminocycline: Change
[Note—The relative retention times for epiminocycline and minocycline are 0.86 and 1.0, respectively.]
to:
[Note—The relative retention times for epiminocycline and minocycline are 0.7 and 1.0, respectively.]
PETROLATUM IMPURITIES/Organic Impurities/Procedure: Organic Acids USP37–NF32 4253 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample solution: Change
20.0 g of Petrolatum in 100 mL of neutralized alcohol and water (1:2).
to:
20.0 g of Petrolatum in 100 mL of a 1 in 2 mixture of neutralized alcohol and water.
WHITE PETROLATUM IMPURITIES/Organic Impurities/Procedure: Organic Acids USP37–NF32 4254 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample solution: Change
20.0 g in 100 mL of neutralized alcohol and water (1:2).
to:
20.0 g of White Petrolatum in 100 mL of a 1 in 2 mixture of neutralized alcohol and water.
SACCHARIN SODIUM IDENTIFICATION/B. Procedure USP37–NF32 4638 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Analysis: Change
To the Sample solution
to:
To 10 mL of the Sample solution
SACCHARIN SODIUM IMPURITIES/Organic Impurities/Procedure 1: Limit of Toluenesulfonamides USP37–NF32 4638 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 4 of Acceptance criteria: Change
of the Internal standard solution
to:
of the caffeine (internal standard)
SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION ASSAY/Procedure USP37–NF32 4784 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Standard solution: Change
in Mobile phase from Sample stock solution
to:
in Mobile phase from Standard stock solution
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION ASSAY/Procedure USP37–NF32 4785 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Standard solution: Change
in Mobile phase from Sample stock solution
to:
in Mobile phase from Standard stock solution
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS ASSAY/Procedure USP37–NF32 4787 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Standard solution: Change
in Mobile phase from Sample stock solution
to:
in Mobile phase from Standard stock solution
ZANAMIVIR ASSAY/Procedure/Chromatographic system USP37–NF32 5197 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Column: Change
5-μm packing L##1
to:
5-μm packing L82
AND
Delete footnote 1
ZANAMIVIR IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 5197 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Column: Change
5-μm packing L##1
to:
5-μm packing L82
SAW PALMETTO EXTRACT COMPOSITION/Content of Long-Chain Alcohols and Sterols USP37–NF32 5545 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Acceptance criteria:Add
The lipophilic Extract contains 0.15%–0.35% of long-chain alcohols, and the hydroalcoholic Extract contains 0.01%–0.15% of long-chain alcohols on the anhydrous basis.
TRIBASIC CALCIUM PHOSPHATE ASSAY/Procedure USP37–NF32 5883 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Delete the subsection
Blank: Proceed as directed in the Analysis, omitting the test specimen.
AND
Equation in Analysis: Change
Result = {[VSVB) × M × F]/W} × 100
to:
Result = [(VRead More
TRIBASIC CALCIUM PHOSPHATE IMPURITIES/Dibasic Salt and Calcium Oxide USP37–NF32 5883 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Delete the subsection
Blank: 25.0 mL of Titrant
COPOVIDONE IMPURITIES/Limit of Monomers (1-Vinyl-2-Pyrrolidone, Vinyl Acetate, and 2-Pyrrolidone) USP37–NF32 5938 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 29 of Analysis: Change
Calculate the content of 2-pyrrolidinone
to:
Calculate the content of 2-pyrrolidone
CHLORPHENIRAMINE MALEATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP37–NF32 6617 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Sample: Change
100 mg/mL in water
to:
100 mg/mL in water at 20°
ERYTHROMYCIN DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Buffer stage First Supplement to USP37–NF32 6633 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution: Change
0.28 mg/mL of USP Erythromycin RS in Medium
to:
Dissolve USP Erythromycin RS in Medium to obtain a concentration similar to that of the Sample solution.
AND
Line 1 of Sample solution: Change
Pass portions of… Read More
TRAZODONE HYDROCHLORIDE IMPURITIES/Limit of Trazodone Related Compound F and Cyclophosphamide Related Compound A/Chromatographic system/MS conditions First Supplement to USP37–NF32 6708 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 4 of Acquisition mode:Change
272
to:
273
TRAZODONE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6708 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 2 of USP Trazodone Related Compound D RS: Change
(2-{3-[4-(4-Bromophenyl)piperazin-1-yl]propyl}-[1,2,4]triazolo[4,3-α]pyridin-3(2H)-one hydrochloride.
to:
2-{3-[4-(3-Bromophenyl)piperazin-1-yl]propyl}-[1,2,4]triazolo[4,3-α]pyridin-3(2H)-one hydrochloride.
GLYCERYL BEHENATE DEFINITION Second Supplement to USP37–NF32 7077 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 7: Change
behenic (docosanic) acid
to:
behenic (docosanoic) acid
HYDROXYPROPYL CELLULOSE ASSAY Second Supplement to USP37–NF32 7080 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Internal standard solution: Change
Methycyclohexane
to:
Methylcyclohexane
POLYSORBATE 80 SPECIFIC TESTS/Fats and Fixed Oils, Acid Value <401> Second Supplement to USP37–NF32 7089 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Analysis: Change
with 0.1 N potassium hydroxide or 0.1 N sodium hydroxide
to:
with 0.1 N potassium hydroxide VS or 0.1 N sodium hydroxide VS
MEBENDAZOLE ASSAY/Procedure Second Supplement to USP37–NF32 7199 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 3 of Analysis: Change
Calculate the percentage of each impurity in the portion of Oral Suspension taken:
to:
Calculate the percentage of mebendazole (C16H13N3O3) in the portion of Mebendazole taken:
SODIUM PICOSULFATE CHEMICAL INFORMATION Second Supplement to USP37–NF32 7253 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 5: Change
Disodium 4,4′-(pyridin-2-ylmethanediyl)dibenzenesulfonate
to:
Disodium 4,4′-(pyridin-2-ylmethanediyl)dibenzenesulfate
GANODERMA LUCIDUM FRUITING BODY COMPOSITION/Content of Triterpenoic Acids Revision Bulletin (Official August 01, 2014) Online 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
rS = peak area of ganoderic acid in Standard solution A
to:
rS… Read More
GANODERMA LUCIDUM FRUITING BODY SPECIFIC TESTS/Botanical Characteristics Revision Bulletin (Official August 01, 2014) Online 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 6 of Macroscopic: Change
concentrically culcate
to:
concentrically sulcate
GANODERMA LUCIDUM FRUITING BODY POWDER COMPOSITION/Content of Triterpenoic Acids Revision Bulletin (Official August 01, 2014) Online 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
rS = peak area of ganoderic acid in Standard solution A
to:
rS… Read More
FENTANYL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP37–NF32 Online 1-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33 Delete
USP Fentanyl Related Compound C RS
AND
Delete
USP Fentanyl Related Compound F RS
NIFEDIPINE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 Second Supplement to USP37–NF32 Online 1-Dec-2014 USP38–NF33 USP38–NF33 Line 1 of Solution A: Change
sodium phosphate
to:
dibasic sodium phosphate
BETAMETHASONE SODIUM PHOSPHATE IMPURITIES/Limit of Free Betamethasone USP37–NF32 1965 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Sample stock solution: Change
1.0 mg/mL of Betamethasone Sodium Phosphate in water
to:
1.0 mg/mL of Betamethasone Sodium Phosphate in water, prepared as follows. Dissolve 25.0 mg of Betamethasone Sodium Phosphate in water to make 25.0 mL.
CALCIUM GLUCONATE INJECTION Identification USP37–NF32 2089 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Identification test A: Change
A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate.
to:
Dissolve a quantity of it in water to… Read More
DACARBAZINE USP Reference standards <11> USP37–NF32 2504 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3 of USP Dacarbazine Related Compound B RS: Change
C4H3N5O 137.10
to:
C4H3N5O · H2O 155.12
ESCITALOPRAM ORAL SOLUTION IMPURITIES/Organic Impurities USP37–NF32 2580 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Row 6 of Column 1 of Table 3: Change
Desfluorocitalopramf
to:
Desfluorocitalopramf,c
DIDANOSINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP37–NF32 2603 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 11 of the variable definition list: Change
CS = concentration of didanosine in the Standard solution (mg/mL)
to:
CS = concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or… Read More
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 2739 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of Detector 2: Change
Monitor the signal at 344 nm between 37 and 42 min.
to:
Monitor the signal at 344 nm for ethinyl estradiol related compound B (typically between 37 and 42 min).
IRINOTECAN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USP37–NF32 3403 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Row 3 of Column 1 of Table 2: Change
Camptothecinb
to:
Camptothecinb,d
AND
Row 5 of Column 1: Change
7-Ethylcamptothecinc
to:
7-Ethylcamptothecinc,d
AND
Add a footnote:
dThese process impuritiesare… Read More
KETOPROFEN EXTENDED-RELEASE CAPSULES ASSAY/Procedure/System suitability/Suitability requirements USP37–NF32 3469 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5
KETOPROFEN EXTENDED-RELEASE CAPSULES PERFORMANCE TESTS/Uniformity of Dosage Units <905>/System suitability/Suitability requirements USP37–NF32 3469 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5
OXYBUTYNIN CHLORIDE SPECIFIC TESTS/Loss on Drying <731> USP37–NF32 4129 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Acceptance criteria: Change
NMT 3.0%
to:
NMT 3%
PSEUDOEPHEDRINE HYDROCHLORIDE ASSAY/Procedure USP37–NF32 4481 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of System suitability solution: Change
0.02 mg/mL of USP Ephedrine Sulfate RS
to:
0.002 mg/mL of USP Ephedrine Sulfate RS
WATER FOR HEMODIALYSIS CHEMICAL INFORMATION USP37–NF32 5173 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5173 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR INHALATION CHEMICAL INFORMATION USP37–NF32 5174 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR INHALATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5174 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
STERILE WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5175 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5175 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
STERILE WATER FOR IRRIGATION CHEMICAL INFORMATION USP37–NF32 5175 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR IRRIGATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5175 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
PURE STEAM CHEMICAL INFORMATION USP37–NF32 5176 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE PURIFIED WATER ADDITIONAL REQUIREMENTS USP37–NF32 5176 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add a section:
USP Reference Standards <11>
USP 1,4-Benzoquinone RS
USP Sucrose RS
CELLACEFATE ASSAY/Content of Acetyl USP37–NF32 5919 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 12 of Analysis:
Result = {[(P − 0.5182 × B)/(100 − B)] − (0.5772 × C)} × 100
to:
Result = 100 × [P − (0.5182 × B)]/(100 − B) − (0.5772 × C)