How to Use the USP–NF Errata Table

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Monograph Title Sectionsort icon Source Publication Page Number Errata Post Date Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
PRILOCAINE AND EPINEPHRINE INJECTION Assay for epinephrine USP35–NF30 4411 28-Sep-2012 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 7 of Procedure: Change
183.21/333.30
to:
183.20/333.29
AND
Line 8 of Procedure: Change
183.21 and 333.30
to:
183.20 and 333.29

Line 7 of Procedure: Change

183.21/333.30

to:

183.20/333.29
AND
Line 8 of Procedure: Change

183.21 and 333.30

to:

183.20 and 333.29
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
AU, AH, and AL
to:
AU, AS1, and AS2
TRIAZOLAM TABLETS Assay USP35–NF30 4936 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 2: Change
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Triazolam.
to:
Mobile phase—Prepare a filtered and degassed mixture of acetonitrile, chloroform, butyl alcohol, water, and glacial acetic acid (850:80:50:20:0.5). Make adjustments if necessary (see System Suitability under Chromatography <621>).
AND
After the Assay preparation subsection: Add a new subsection
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 30-cm column that contains packing L3. The flow rate is about 2.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the relative retention times are 1 for triazolam and about 1.4 for the internal standard, the resolution, R, between the internal standard and triazolam is not less than 2.0, and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Line 4 of Procedure: Change
Calculate the quantity, in mg, of C17H12Cl2N4 in the portion of Triazolam taken by the formula:
to:
Calculate the quantity, in mg, of C17H12Cl2N4 in the portion of Tablets taken by the formula:
AND
Line 9 of Procedure: Change
RU and RS are the ratios of the internal standard peak area to the triazolam peak area obtained from the Assay preparation and the Standard preparation, respectively.
to:
RU and RS are the ratios of the triazolam peak area to the internal standard peak area obtained from the Assay preparation and the Standard preparation, respectively.

Line 2: Change
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Triazolam.
to:
Mobile phase—Prepare a filtered and degassed mixture of acetonitrile, chloroform, butyl alcohol, water, and glacial acetic acid (850:80:50:20:0.5). Make adjustments if necessary (see System Suitability under Chromatography <621>).
AND
After the Assay preparation subsection: Add a new subsection

 Read More
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE Assay USP35–NF30 1822 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 2: Change
Hypromellose 2906, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose 2906 throughout.
to:
Hypromellose, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose throughout.

Line 2: Change
Hypromellose 2906, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose 2906 throughout.

to:
Hypromellose, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose throughout.
CAPTOPRIL ORAL SOLUTION Assay USP35–NF30 2477 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.
to:
Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas.

Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.

to:
Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas.
CAPTOPRIL ORAL SUSPENSION Assay USP35–NF30 2477 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.
to:
Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas.

Line 1 of Mobile phase: Change
Prepare a filtered and degassed mixture of methanol and water (11:9) containing 0.5 mL of phosphoric acid.

to:
Methanol and water (55:45) containing 0.5 mL/L of phosphoric acid. Filter, and degas.
ATROPINE SULFATE TABLETS Assay USP35–NF30 2272 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 9 of Procedure: Change
RU and RS are as defined therein.
to:
RU and RS are the peak area ratios of atropine to homatropine.

Line 9 of Procedure: Change
RU and RS are as defined therein.
to:
RU and RS are the peak area ratios of atropine to homatropine.
VINORELBINE INJECTION Assay USP35–NF30 5028 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1: Change
Phosphate buffer, Mobile phase, and System suitability solution—Proceed as directed in the Assay under Vinorelbine Tartrate.
to:
Phosphate buffer—Dissolve 6.9 g of monobasic sodium phosphate in 900 mL of water. Adjust with phosphoric acid to a pH of 4.2, dilute with water to 1000 mL, and mix.
Mobile phase—Dissolve 1.22 g of sodium 1-decanesulfonate in 620 mL of methanol. Add 380 mL of Phosphate buffer, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
System suitability solution—Dissolve accurately weighed quantities of USP Vinorelbine Tartrate RS and USP Vinorelbine Related Compound A RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having known concentrations of about 1.4 mg per mL and 0.01 mg per mL, respectively. Expose a portion of this solution in a suitable xenon lamp apparatus capable of supplying a dose of 1600 KJ/m2 between 310 and 800 nm at a power of 500 W/m2 for about 1 h, in order to generate an additional degradation product 3,6-epoxy vinorelbine having a relative retention time of about 0.8.

Line 1: Change
Phosphate buffer, Mobile phase, and System suitability solution—Proceed as directed in the Assay under Vinorelbine Tartrate.
to:
Phosphate buffer—Dissolve 6.9 g of monobasic sodium phosphate in 900 mL of water. Adjust with phosphoric acid to a pH of 4.2, dilute with water to 1000 mL, and mix.

 Read More
IFOSFAMIDE Chloroform-insoluble phosphorus USP35–NF30 3477 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 18 of Test preparation: Change
ammonium hydroxide solution.
to:
ammonium hydroxide.

Line 18 of Test preparation: Change
ammonium hydroxide solution.
to:
ammonium hydroxide.
NAFTIFINE HYDROCHLORIDE GEL Content of alcohol USP35–NF30 3983 28-Sep-2012 01-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:

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:
METFORMIN HYDROCHLORIDE TABLETS Dissolution <711>/Test 3 USP35–NF30 3830 28-Sep-2012 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Lines 6 and 7 of Procedure: Change
rU × CS × 900 × 100/rS × D × LC
to:
rU × CS × 1000 × 100/rS × D × LC
AND
Line 11 of Procedure: Change
900 is the volume
to:
1000 is the volume

Lines 6 and 7 of Procedure: Change
rU × CS × 900 × 100/rS × D × LC
to:

rU × CS × 1000 × 100/rS × D × LC
AND
Line 11 of Procedure: Change

900 is the volume

to:

1000 is the volume
<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
70
to:
100
AND
Row 16 of Column 5 of Table 1: Change
25
to:
10
<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
7
to:
10
DESCRIPTION AND SOLUBILITY Ethylcellulose Dispersion Type B USP35–NF30 1118 28-Sep-2012 01-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.

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.
POLYVINYL ALCOHOL Identification test C USP35–NF30 4351 28-Sep-2012 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 5: Change
Add 10 mL of alcohol to the remaining 5 mL of the polyvinyl alcohol solution, and mix
to:
Add 10 mL of alcohol to the remaining 2 mL of the polyvinyl alcohol solution, and mix.

Line 5: Change

Add 10 mL of alcohol to the remaining 5 mL of the
polyvinyl alcohol solution, and mix

to:
Add 10 mL of alcohol to the remaining 2 mL of the polyvinyl alcohol solution, and mix.
BETAMETHASONE ORAL SOLUTION Identification/A: USP35–NF30 2336 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 1: Change
A:
to:
A: Thin-Layer Chromatographic Identification Test <201>—

Line 1: Change
A:

to:
A:
Thin-Layer Chromatographic Identification Test <201>—
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
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.
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
Use the Assay preparation, prepared as directed in the Assay.
to:

 Read More
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:
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:

 Read More
TAPIOCA STARCH Limit of oxidizing substances USP35–NF30 1987 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 8: Change
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodide color.
to:
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodine color.

Line 8: Change
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodide color.
to:
Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodine color.
NORGESTIMATE Limit of residual solvents USP35–NF30 4083 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Limit of residual solvents: Change
to:
Limit of residual solvents <467>

Line 1 of Limit of residual solvents: Change
to:
Limit of residual solvents <467>
BRINZOLAMIDE Related compounds/Test 2 USP35–NF30 2385 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 15 of Procedure: Change
relative retention time greater than 6.
to:
relative retention greater than 6.

Line 15 of Procedure: Change
relative retention time greater than 6.
to:
relative retention greater than 6.
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
Inject a volume (about 0.5 µL)
to:
Inject a volume (about 2.0 µL)
METRONIDAZOLE Related compounds USP35–NF30 3905 28-Sep-2012 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 19 of Procedure: Change
ri is the peak response for any unspecified degradation product peak in the Test solution
to:
ri is the peak response for any single unspecified impurity in the Test solution

Line 19 of Procedure: Change

ri is the peak response for any unspecified degradation
product peak in the Test solution
to:

ri is the peak response for any single unspecified impurity
in the Test solution
VINORELBINE INJECTION Related compounds USP35–NF30 5028 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Delete the subsection Standard solution and Diluted standard solution.
Replace with:
Standard solution—Dissolve an accurately weighed quantity of USP Vinorelbine Tartrate RS in Mobile phase to obtain a solution having a known concentration of about 1.4 mg per mL.
Diluted standard solution—Transfer 1.0 mL of the Standard solution to a 50-mL volumetric flask, and dilute with Mobile phase to volume. Pipet 1.0 mL of this solution into a 100-mL volumetric flask, and dilute with Mobile phase to volume.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related compounds under Vinorelbine Tartrate.
to:
Separately inject equal volumes (about 20 µL) of the Test solution and the Diluted standard solution into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Record the chromatograms for three times the retention time of the vinorelbine peak. Disregard any peaks with an area less than or equal to one-half of the area of the peak obtained for vinorelbine in the Diluted standard solution. Calculate the percentage of each impurity in the portion of Injection taken by the formula:
100(ri/rs)
in which ri is the peak response for each impurity obtained from the Test solution; and rs is the sum of the responses of all the peaks.

Delete the subsection Standard solution and Diluted standard solution.
Replace with:
Standard solution—Dissolve an accurately weighed quantity of USP Vinorelbine Tartrate RS in Mobile phase to obtain a solution having a known concentration of about 1.4 mg per mL.
Diluted standard solution—Transfer 1.0 mL of the Standard solution to a 50-mL volumetric flask, and dilute with Mobile phase to volume. Pipet 1.0 mL of this solution into a 100-mL volumetric flask, and dilute with Mobile phase to volume.
AND

 Read More
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
The flow rate is about 0.5 mL per minute.
<81> Antibiotics—Microbial Assays Turbidimetric Method USP35–NF30 74 30-Nov-2012 01-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.

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.
ONDANSETRON INJECTION USP Reference Standards USP35–NF30 4120 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 7: Delete
USP Ondansetron Related Compound B RS
6,6´-Methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)-methyl]-4H-carbazol-4-one.

Line 7: Delete
USP Ondansetron Related Compound B RS

6,6´-Methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)-methyl]-4H-carbazol-4-one.
<1050> VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN VI. Evaluation and Characterization of Viral Clearance Procedures USP35–NF30 553 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Row 10 (Reovirus 3) of Column 5 (Genome) of Table A-1: Change
DNA
to:
RNA

Row 10 (Reovirus 3) of Column 5 (Genome) of Table A-1: Change
DNA
to:
RNA
<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

Volume of 1 more containers is less than 95% LV
to:

Volume of 1 or more containers is less than 95% LV
LEVETIRACETAM ADDITIONAL REQUIREMENTS USP35–NF30 3659 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 9 of USP Reference Standards <11>: Change
C8H14ClNO3 207.65
to:
C8H15ClN2O2 206.67

Line 9 of USP Reference Standards <11>: Change

C8H14ClNO3 207.65

to:

C8H15ClN2O2 206.67
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
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.

 Read More
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
USP Meprobamate RS
LORATADINE ORALLY-DISINTEGRATING TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards USP35–NF30 3714 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 4 of USP Reference Standards: Change
8-Chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
to:
8-Chloro-5,6-dihydro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine.
AND
Line 6: Change
310.83
to:
310.82
AND
Line 8: Change
8-Chloro-6,11-dihydro-11-(N-methyl-4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
to:
8-Chloro-5,6-dihydro-11-(N-methylpiperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine.
AND
Line 10: Change
324.88
to:
324.85

Line 4 of USP Reference Standards: Change
8-Chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
to:
8-Chloro-5,6-dihydro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine.
AND
Line 6: Change
310.83
to:
310.82
AND
Line 8: Change
8-Chloro-6,11-dihydro-11-(N-methyl-4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
to:

 Read More
TREHALOSE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP35–NF30 2007 28-Sep-2012 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 2: Delete
USP Glycerin RS

Line 2: Delete

USP Glycerin RS
<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
Pd
to:
Pb
Metronidazole ASSAY USP36–NF31 4352 30-Nov-2012 01-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

Line 8 of Chromatogaphic system: Add new subsection after Injection volume:
Run time: Twice the retention time of metronidazole
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
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution
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
W = Sample weight (mg)
to:
W = Sample weight (mg) in 20.0 mL of the Sample solution
ACETAZOLAMIDE FOR INJECTION ASSAY USP35–NF30 2063 28-Sep-2012 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 19: Change
25C(AU/AS)
to:
250C(AU/AS)

Line 19: Change
25C(AU/AS)

to:
250C(AU/AS)
GANCICLOVIR ORAL SUSPENSION ASSAY USP35–NF30 3319 28-Sep-2012 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1 of Internal standard solution: Change
4 mg per mL
to:
0.4 mg per mL

Line 1 of Internal standard solution: Change

4 mg per mL

to:

0.4 mg per mL
TACROLIMUS ORAL SUSPENSION ASSAY/Chromatographic system USP36–NF31 5261 31-Jan-2013 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
After line 1 of Column: Add a new section
Column temperature: 70°

After line 1 of Column: Add a new section
Column temperature: 70°
HYDROGENATED POLYDECENE ASSAY/Content of Decene Oligomer USP36–NF31 2133 29-Mar-2013 01-Apr-2013 USP37–NF32 USP37–NF32
Line 3 of System suitability: Change
[Note—The retention time for squalene is about 18 min; the relative retention times for tetradecane, hexadecane, and squalene are about 0.5, 0.6, and 1.0, respectively.]
to:
[Note—The retention time for squalane is about 18 min; the relative retention times for tetradecane, hexadecane, and squalane are about 0.5, 0.6, and 1.0, respectively.]

Line 3 of System suitability: Change
[Note—The retention time for squalene is about 18 min; the relative retention times for tetradecane, hexadecane, and squalene are about 0.5, 0.6, and 1.0, respectively.]

to:
[Note—The retention time for squalane is about 18 min; the relative retention times for tetradecane, hexadecane, and squalane are about 0.5, 0.6, and 1.0, respectively.]
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
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.
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
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:
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
Epimer A: 40.0%–51.0% on the dried basis

to:
Epimer A: 40.0%–51.0%
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
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)
CALCIUM SULFATE ASSAY/Procedure USP35–NF30 1724 28-Sep-2012 01-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) × N × F × 100]/W
to:
Result = [(V × N × F)/W] × 100
AND
Line 15 of Analysis: Delete
B = volume of titrant consumed by the Blank (mL)

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) × N × F × 100]/W
to:

Result = [(V × N × F)/W] × 100

AND
Line 15 of Analysis: Delete

B = volume of titrant consumed by the Blank (mL)
METHYL ALCOHOL ASSAY/Procedure USP35–NF30 1865 28-Sep-2012 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 9 of System suitability: Change
Tailing factor: NLT 1.5 for methyl alcohol, System suitability solution
to:
Tailing factor: NMT 1.5 for methyl alcohol, System suitability solution

Line 9 of System suitability: Change

Tailing factor: NLT 1.5 for methyl alcohol, System
suitability solution
to:

Tailing factor: NMT 1.5 for methyl alcohol, System
suitability solution
SODIUM HYDROXIDE ASSAY/Procedure USP35–NF30 1955 28-Sep-2012 01-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 Analysis: Change
VS1
to:
VS2

Line 10 of Analysis: Change

Result = {[(VS1 − VB) × N × F1]/W} × 100

to:

Result = {[(VS2 − VB) × N × F1]/W} × 100

AND
Line 11 of Analysis: Change

VS1
to:

VS2
XLS CSV