How to Use the USP–NF Errata Table

  • Searching: Type keyword in search field at top of page. Search by all or part of a monograph title. For searches using multiple criteria, you will find items that match each of the specified criteria unless quotation marks are used.
    • For example, a search on Aminosalicylic Acid Tablets will result in anything that contains “Aminosalicyclic” OR “Acid” OR “Tablets”
    • A search for “Aminosalicylic Acid Tablets” will result in anything that specifically contains “Aminosalicylic Acid Tablets”
  • Sorting: Click on any blue column header title to sort alphabetically or chronologically in ascending or descending order. Note: the page load column is sorted alphabetically so that a number is ordered by first digit vs. by the actual number; thus, numbers will not always be in order.
    • For example, page 2178 will come before page 74 on a page sort.
  • Downloading: You can download the Errata table in Comma-separated Value (.csv) or Excel format (.xls). The download will include all Errata from the database.
  • Printing: The table will print the view of the data as it has been filtered or sorted. To print a table of all Errata in the database, clear any keyword searches you have applied and select “Show: All”.
Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability USP37–NF32 1301 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 11 of Method 2—Multichannel Instruments: Change
NMT ±10% of stated size.
to:
NMT ±10% of stated concentration.


Line 11 of Method 2—Multichannel Instruments: Change
NMT ±10% of stated size.
to:
NMT ±10% of stated concentration.

<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS USP37–NF32 315 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change
A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
to:
A single-unit package for an article intended for parenteral administration. A single-dose container is labeled as such. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.


Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change
A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
to:
A single-unit package for an article intended for parenteral administration. A single-dose container is labeled as such.

Read more
CEFADROXIL FOR ORAL SUSPENSION IDENTIFICATION/Thin-Layer Chromatography/Chromatographic system USP37–NF32 2182 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 2 of Developing solvent system: Change
(60:40:15)
to:
(60: 40: 1.5)


Line 2 of Developing solvent system: Change
(60:40:15)
to:
(60: 40: 1.5)

CEFUROXIME AXETIL FOR ORAL SUSPENSION ASSAY/Procedure USP37–NF32 2243 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Change
Buffer: 23 mg/mL of monobasic ammonium phosphate in water
to:
Solution A: 23 g/L of monobasic ammonium phosphate in water
AND
Line 4 of System suitability solution: Change
Dilute with Buffer to volume.
to:
Dilute with Solution A to volume.
AND
Line 3 of Standard solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.
AND
Line 3 of Sample solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.

















Change
Buffer: 23 mg/mL of monobasic ammonium phosphate in water

to:
Solution A: 23 g/L of monobasic ammonium phosphate in water
AND
Line 4 of System suitability solution: Change
Dilute with Buffer to volume.
to:
Dilute with Solution A to volume.
AND
Line 3 of Standard solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.
AND
Line 3 of Sample solution: Change
and dilute with Buffer to volume.
to:
and dilute w

Read more
CHLORPHENIRAMINE MALEATE SPECIFIC TESTS/Optical Rotation, Specific Rotation <781> First Supplement to USP37–NF32 6617 01-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°


Line 1 of Sample: Change
100 mg/mL in water
to:
100 mg/mL in water at 20°

COPOVIDONE IMPURITIES/Limit of Monomers (1-Vinyl-2-Pyrrolidone, Vinyl Acetate, and 2-Pyrrolidone) USP37–NF32 5938 01-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


Line 29 of Analysis: Change
Calculate the content of 2-pyrrolidinone
to:
Calculate the content of 2-pyrrolidone

DOLASETRON MESYLATE CHEMICAL INFORMATION USP37–NF32 2693 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 7: Change
[115956-13-3].
to:
[878143-33-0]
Anhydrous [115956-13-3].



Line 7: Change
[115956-13-3].

to:
[878143-33-0]
Anhydrous [115956-13-3].

ERYTHROMYCIN DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1/Buffer stage First Supplement to USP37–NF32 6633 01-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 the solution under test through a suitable filter.
to:
If necessary, dilute a filtered portion of the solution under test with Medium to obtain a solution containing about 0.28 mg/mL of erythromycin.







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 the solution under test through a suitable filter.
to:
If necessary, dilute a filtered portion of the solution under test with Medium to obtain a solution containing about 0.28 mg/mL of erythromycin.

FENTANYL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP37–NF32 ONLINE 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Delete
USP Fentanyl Related Compound C RS
AND
Delete
USP Fentanyl Related Compound F RS



Delete
USP Fentanyl Related Compound C RS
AND
Delete
USP Fentanyl Related Compound F RS

FLUDARABINE PHOSPHATE IMPURITIES/Limit of Sodium USP37–NF32 3003 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Standard solution: Change
1 µg/mL of sodium chloride in water
to:
1 µg/mL of sodium in water


Line 1 of Standard solution: Change
1 µg/mL of sodium chloride in water
to:
1 µg/mL of sodium in water

FLUTAMIDE ASSAY/Procedure USP37–NF32 3057 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 2 of Sample solution: Change
Dissolve the sample in acetonitrile
to:
Dissolve a previously dried sample in acetonitrile


Line 2 of Sample solution: Change
Dissolve the sample in acetonitrile
to:
Dissolve a previously dried sample in acetonitrile

GANODERMA LUCIDUM FRUITING BODY SPECIFIC TESTS/Botanical Characteristics Revision Bulletin (Official August 01, 2014) ONLINE 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 6 of Macroscopic: Change
concentrically culcate
to:
concentrically sulcate


Line 6 of Macroscopic: Change
concentrically culcate
to:
concentrically sulcate

GANODERMA LUCIDUM FRUITING BODY COMPOSITION/Content of Triterpenoic Acids Revision Bulletin (Official August 01, 2014) ONLINE 01-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
r S = peak area of ganoderic acid in Standard solution A
to:
r S = peak area of ganoderic acid A in Standard solution A
AND
Line 10 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response factor, with respect to ganoderic acid A (see Table 2)












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
r

S
= peak area of ganoderic acid in Standard solution A

to:
r

S
= peak area of ganoderic acid A in Standard solution A

AND
Line 10 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response f

Read more
GANODERMA LUCIDUM FRUITING BODY POWDER COMPOSITION/Content of Triterpenoic Acids Revision Bulletin (Official August 01, 2014) ONLINE 01-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
r S = peak area of ganoderic acid in Standard solution A
to:
r S = peak area of ganoderic acid A in Standard solution A
AND
Line 11 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response factor, with respect to ganoderic acid A (see Table 2)












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
r

S
= peak area of ganoderic acid in Standard solution A

to:
r

S
= peak area of ganoderic acid A in Standard solution A

AND
Line 11 of variable definition list in Analysis: Change

F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response

Read more
GLYCERYL BEHENATE DEFINITION Second Supplement to USP37–NF32 7077 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 7: Change
behenic (docosanic) acid
to:
behenic (docosanoic) acid


Line 7: Change
behenic (docosanic) acid
to:
behenic (docosanoic) acid

HYDROXYPROPYL CELLULOSE ASSAY Second Supplement to USP37–NF32 7080 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Internal standard solution: Change
Methycyclohexane
to:
Methylcyclohexane


Line 1 of Internal standard solution: Change
Methycyclohexane
to:
Methylcyclohexane

LAMIVUDINE AND ZIDOVUDINE TABLETS IMPURITIES/Organic Impurities USP37–NF32 3484 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Row 17 of Column 1 of Table 2: Change
(the limit includes individual unidentified impurities)
to:
(the limit includes individual unspecified impurities)


Row 17 of Column 1 of Table 2: Change
(the limit includes individual unidentified impurities)
to:
(the limit includes individual unspecified impurities)

MANNITOL INJECTION Assay USP37–NF32 3653 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Change:
Mobile phase, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Mannitol.
to:
Mobile phase—Use degassed water.
Resolution solution—Dissolve sorbitol and USP Mannitol RS in water to obtain a solution having concentrations of about 4.8 mg per mL of each.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a refractive index detector that is maintained at a constant temperature and a 4-mm × 25-cm column that contains packing L19. The column temperature is maintained at a temperature between 30° and 85° controlled within ±2° of the selected temperature, and the flow rate is about 0.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%. In a similar manner, chromatograph the Resolution solution: the resolution, R, between the sorbitol and mannitol peaks is not less than 2.0.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Mannitol.
to:
Separately inject equal volumes (about 20 µL) of the Assay preparation and the Standard preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.









Change:
Mobile phase, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Mannitol.

Read more
MEBENDAZOLE ASSAY/Procedure Second Supplement to USP37–NF32 7199 01-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:


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:

METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> USP37–NF32 3732 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Equation in Test 1: Change
Result = [(AU /AS ) × CS × (VVS ) + (C60 × VS ) + (C180 × VS ) × 100]/L
to:
Result = [(AU /AS ) × CS × (VVS ) + (C60 × VS ) + (C180 × VS )] × (100/L)
AND
Equation 3 in Test 2: Change
Result = [C2 × (VSV1 ) + C1 × SV1 × 100]/L
to:
Result = [C2 × (VSV1 ) + C1 × SV1 ] × (100/L)
AND
Equation 4 in Test 2: Change
Result = {Cn × [V − (n − 1)VS ] + (C1 + C2 + ... + Cn-1 ) × VS × 100}/L
to:
Result = {Cn × [V − (n − 1)VS ] + (C1 + C2 + ... + Cn-1 ) × VS } × (100/L)












Equation in Test 1: Change
Result = [(AU
/AS
) × CS
× (VVS
) + (C60
×

VS
) + (C180
×

VS
) ×

100]/L

to:
Result =
[(AU
/AS
) × CS
× (VVS
) + (C60
×

VS
) + (C180
×

VS
)] ×

(100/L)

AND
Equation 3 in Test 2: Change
Resul

Read more
MINOCYCLINE FOR INJECTION IMPURITIES USP37–NF32 3843 01-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.]


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.]

NIFEDIPINE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 Second Supplement to USP37–NF32 ONLINE 01-Dec-2014 USP38–NF33 USP38–NF33
Line 1 of Solution A: Change
sodium phosphate
to:
dibasic sodium phosphate


Line 1 of Solution A: Change
sodium phosphate
to:
dibasic sodium phosphate

PETROLATUM IMPURITIES/Organic Impurities/Procedure: Organic Acids USP37–NF32 4253 01-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.


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.

POLYSORBATE 80 SPECIFIC TESTS/Fats and Fixed Oils, Acid Value <401> Second Supplement to USP37–NF32 7089 01-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


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

SACCHARIN SODIUM IMPURITIES/Organic Impurities/Procedure 1: Limit of Toluenesulfonamides USP37–NF32 4638 01-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)


Line 4 of Acceptance criteria: Change
of the Internal standard solution

to:
of the caffeine (internal standard)

SACCHARIN SODIUM IDENTIFICATION/B. Procedure USP37–NF32 4638 01-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


Line 1 of Analysis: Change
To the Sample solution

to:
To 10 mL of the Sample solution

SAW PALMETTO EXTRACT COMPOSITION/Content of Long-Chain Alcohols and Sterols USP37–NF32 5545 01-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.

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.

SODIUM PICOSULFATE CHEMICAL INFORMATION Second Supplement to USP37–NF32 7253 01-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


Line 5: Change
Disodium 4,4′-(pyridin-2-ylmethanediyl)dibenzenesulfonate
to:
Disodium 4,4′-(pyridin-2-ylmethanediyl)dibenzenesulfate

SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION ASSAY/Procedure USP37–NF32 4784 01-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


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 01-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


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 01-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


Line 3 of Standard solution: Change
in Mobile phase from Sample stock solution

to:
in Mobile phase from Standard stock solution

TRAZODONE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6708 01-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.


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.

TRAZODONE HYDROCHLORIDE IMPURITIES/Limit of Trazodone Related Compound F and Cyclophosphamide Related Compound A/Chromatographic system/MS conditions First Supplement to USP37–NF32 6708 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 4 of Acquisition mode: Change
272
to:
273


Line 4 of Acquisition mode:
Change
272
to:
273

TRIBASIC CALCIUM PHOSPHATE IMPURITIES/Dibasic Salt and Calcium Oxide USP37–NF32 5883 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Delete the subsection
Blank: 25.0 mL of Titrant

Delete the subsection
Blank: 25.0 mL of Titrant

TRIBASIC CALCIUM PHOSPHATE ASSAY/Procedure USP37–NF32 5883 01-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 = {[V S V B ) × M × F]/W} × 100
to:
Result = [(V S × M × F)/W] × 100
AND
Line 2 of the variable definition list in Analysis: Delete
V B = Titrant volume consumed by the Blank (mL)








Delete the subsection
Blank: Proceed as directed in the Analysis, omitting the test specimen.
AND
Equation in Analysis: Change
Result = {[V

S
V

B
) × M × F]/W} × 100
to:
Result = [(V

S
× M × F)/W] × 100
AND
Line 2 of the variable definition list in Analysis: Delete
V

B
= Titrant volume consumed by the Blank (mL)

WHITE PETROLATUM IMPURITIES/Organic Impurities/Procedure: Organic Acids USP37–NF32 4254 01-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.


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.

ZANAMIVIR IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 5197 01-Dec-2014 USP39–NF34 Second Supplement to USP38–NF33
Line 1 of Column: Change
5-μm packing L##1
to:
5-μm packing L82


Line 1 of Column: Change
5-μm packing L##1

to:
5-μm
packing L82

ZANAMIVIR ASSAY/Procedure/Chromatographic system USP37–NF32 5197 01-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




Line 1 of Column: Change
5-μm packing L##1

to:
5-μm
packing L82
AND
Delete footnote 1

BETAMETHASONE SODIUM PHOSPHATE IMPURITIES/Limit of Free Betamethasone USP37–NF32 1965 01-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.


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 01-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 obtain a test solution containing 10 mg per mL, heating in a water bath at 60° if necessary. Similarly, prepare a Standard solution of USP Potassium Gluconate RS in water containing 10 mg per mL. Apply separate 5-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel, and allow to dry. Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50: 30: 10: 10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110° for 20 minutes. Allow to cool, spray with a spray reagent prepared as follows. Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. Heat the plate at 110° for about 10 minutes: the principal spot obtained from the test solution corresponds in color, size, and RF value to that obtained from the Standard solution.


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 obtain a test solution containing 10 mg per mL,
heating in a water bath at 60° if necessary. Similarly, prepare a Standard solution of USP Potassium Gluconate RS in water containing 10 mg per mL.

Read more
CELLACEFATE ASSAY/Content of Acetyl USP37–NF32 5919 01-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)


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)

CHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6617 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Standard solution: Change
1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,
to:
1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,


Line 1 of Standard solution: Change
1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,

to:
1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,

DACARBAZINE USP Reference standards <11> USP37–NF32 2504 01-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


Line 3 of USP Dacarbazine Related Compound B RS: Change
C4H3N5O 137.10
to:
C4H3N5O · H2O 155.12

DACARBAZINE FOR INJECTION IMPURITIES/Limit of 2-Azahypoxanthine Second Supplement to USP37–NF32 ONLINE 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 2 of Analysis: Change
2-azahypoxanthine monohydrate
to:
2-azahypoxanthine


Line 2 of Analysis: Change
2-azahypoxanthine monohydrate
to:
2-azahypoxanthine

DEXCHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6626 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 1 of Standard solution:
2.2 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,
to:
2.8 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,


Line 1 of Standard solution:
2.2 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,
to:
2.8 μg/mL of USP Dexchlorpheniramine Maleate RS in Diluent,

DIDANOSINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP37–NF32 2603 01-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 concentration of USP Didanosine RS in the Standard solution for the Buffer stage (mg/mL)


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 concentration of USP Didanosine RS in the Standard solution for the Buffer stage (mg/mL)

DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS IMPURITIES/Organic Impurities/Chromatographic system USP37–NF32 2739 01-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).


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).

ESCITALOPRAM ORAL SOLUTION IMPURITIES/Organic Impurities USP37–NF32 2580 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Row 6 of Column 1 of Table 3: Change
Desfluorocitalopramf
to:
Desfluorocitalopramf,c


Row 6 of Column 1 of Table 3: Change
Desfluorocitalopramf

to:
Desfluorocitalopramf,c

ETHYLCELLULOSE DISPERSION TYPE B ASSAY/Procedure USP37–NF32 5981 01-Oct-2014 USP39–NF34 First Supplement to USP38–NF33
Line 3 of Analysis: Change
Calculate the percentage of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:
to:
Calculate the percentage of the labeled amount of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:


Line 3 of Analysis: Change
Calculate the percentage of ethylcellulose in the portion of
Ethylcellulose Dispersion Type B taken:
to:
Calculate the percentage of the labeled amount of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:

IRINOTECAN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USP37–NF32 3403 01-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 impurities are included in the table for identification only and are not included in the Total impurities.










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 impurities
are included in the table for identification only and are not included in the Total impurities.

XLS CSV