How to Use the USP–NF Errata Table

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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
PHENYLALANINE IMPURITIES USP35–NF30 4296 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 1 of Heavy Metals, Method I <231>: Change
Method I
to:
Method II

Line 1 of Heavy Metals, Method I <231>: Change
Method I
to:
Method II

TACROLIMUS ORAL SUSPENSION ASSAY/Chromatographic system USP36–NF31 5261 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°

TRIAZOLAM TABLETS Assay USP35–NF30 4936 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
VINCRISTINE SULFATE IMPURITIES/Organic Impurities USP35–NF30 5022 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Analysis: Change
Result = [rUA/(ΣrUA + 25rUB)] × 100
to:
Result = [rUA/(ΣrUA + 30rUB)] × 100
AND
Change line 12 of Analysis:
Result = [ΣrUA/(ΣrUA + 25rUB)] × 100
to:
Result = [ΣrUA/(ΣrUA + 30rUB)] × 100

Line 5 of Analysis: Change
Result = [rUA/(ΣrUA + 25rUB)] × 100
to:
Result = [rUA/(ΣrUA + 30rUB)] × 100
AND
Change line 12 of Analysis:
Result = [ΣrUA/(ΣrUA + 25rUB)] × 100
to:
Result = [ΣrUA/(ΣrUA + 30rUB)] × 100

ZINC GLUCONATE IMPURITIES/Limit of Cadmium USP35–NF30 5070 01-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31
Line 22 of Analysis: Change
W = weight of Calcium Gluconate taken to prepare Sample solution A (g)
to:
W = weight of Zinc Gluconate taken to prepare Sample solution A (g)

Line 22 of Analysis: Change
W = weight of Calcium Gluconate taken to prepare Sample solution A (g)
to:
W = weight of Zinc Gluconate taken to prepare Sample solution A (g)

<660> Containers—Glass SPECIFIC TESTS/Hydrolytic Resistance/Method First Supplement to USP35–NF30 5150 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
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.

<81> Antibiotics—Microbial Assays Turbidimetric Method USP35–NF30 74 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.

Aminosalicylate Sodium Limit of m-aminophenol USP35–NF30 2177 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 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 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
Ampicillin Sodium SPECIFIC TESTS/pH <791> USP35–NF30 2213 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
10.0 mg/mL
to:
10.0 mg/mL of ampicillin

Anhydrous Dibasic Calcium Phosphate ASSAY USP35–NF30 2464 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

Anhydrous Dibasic Calcium Phosphate IMPURITIES/Heavy Metals, Method I <231> USP35–NF30 2464 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
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.

Budesonide ASSAY/Procedure USP35–NF30 2394 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%

Carisoprodol Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP35–NF30 5921 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

Cefepime for Injection IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine Second Supplement to USP35–NF30 5925 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
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.

Cefepime Hydrochloride IMPURITIES/Organic Impurities/Procedure 1: Limit of N-Methylpyrrolidine Second Supplement to USP35–NF30 5923 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
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."

Cod Liver Oil ASSAY/Vitamin D USP35–NF30 2756 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
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.

Compound Undecylenic Acid Ointment Assay for zinc undecylenate USP35–NF30 4978 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

Dibasic Calcium Phosphate Dihydrate ASSAY USP35–NF30 2463 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

Dibasic Calcium Phosphate Dihydrate IMPURITIES/Heavy Metals, Method I <231> USP35–NF30 2463 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
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.

Esomeprazole Magnesium Delayed-Release Capsules ASSAY/Procedure First Supplement to USP35–NF30 5473 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.

Esomeprazole Magnesium Delayed-Release Capsules PERFORMANCE TESTS/Dissolution <711> First Supplement to USP35–NF30 5473 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
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.

Esterified Estrogens Tablets ASSAY/Procedure First Supplement to USP35–NF30 5485 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:

Glimepiride Tablets PERFORMANCE TESTS/Dissolution/Test 1 USP35–NF30 3335 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

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

Itraconazole IMPURITIES/Organic Impurities First Supplement to USP35–NF30 5508 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
1.0 µg/mL of USP Itraconazole RS in Diluent
to:
10.0 µg/mL of USP Itraconazole RS in Diluent

Metronidazole ASSAY USP36–NF31 4352 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

Moxifloxacin Ophthalmic Solution Related compounds/Test 1 USP35–NF30 3960 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.

Olanzapine Tablets ASSAY/Procedure Revision Bulletin (Official July 01, 2012) Online 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)

Olanzapine Tablets IMPURITIES/Organic Impurities Revision Bulletin (Official July 01, 2012) Online 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
CU = concentration of olanzapine in the Sample solution (mg/mL)
to:
CU = nominal concentration of olanzapine in the Sample solution (mg/mL)

Olanzapine Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official July 01, 2012) Online 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
Omega-3-Acid Ethyl Esters Capsules SPECIFIC TESTS/Microbial Enumeration <61> First Supplement to USP35–NF30 5524 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
103
to:
103 cfu/g
AND
Line 3: Change
102
to:
102 cfu/g

Polysorbate 80 SPECIFIC TESTS/Fats and Fixed Oils, Saponification Value <401> USP35–NF30 1920 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
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

Polysorbate 80 SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USP35–NF30 1920 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 13 of Analysis: Change
0.5 N alcoholic potassium hydroxide
to:
0.5 N alcoholic potassium hydroxide VS

Line 13 of Analysis: Change
0.5 N alcoholic potassium hydroxide
to:
0.5 N alcoholic potassium hydroxide VS

Polysorbate 80 SPECIFIC TESTS/Fats and Fixed Oils, Peroxide Value <401> USP35–NF30 1920 01-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31
Line 5 of Analysis: Change
0.01 M sodium thiosulfate
to:
0.01 M sodium thiosulfate VS

Line 5 of Analysis: Change
0.01 M sodium thiosulfate
to:
0.01 M sodium thiosulfate VS

Tramadol Hydrochloride Tablets IMPURITIES/Organic Impurities/Procedure USP35–NF30 4905 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
Result = (rU/rS) × (CS/CU) × (1/F) × 0.1
to:
Result = (rU/rS) × (CS/CU) × (1/F) × 100

Triclosan Related compounds USP35–NF30 4939 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)

<232> ELEMENTAL IMPURITIES—LIMITS DRUG SUBSTANCE AND EXCIPIENTS Second Supplement to USP35–NF30 5633 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
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

<232> ELEMENTAL IMPURITIES—LIMITS ANALYTICAL TESTING Second Supplement to USP35–NF30 5633 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 6: Change
Pd
to:
Pb

Line 6: Change
Pd
to:
Pb

<232> ELEMENTAL IMPURITIES—LIMITS DRUG SUBSTANCE AND EXCIPIENTS Second Supplement to USP35–NF30 5633 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
25
to:
1.0

<232> ELEMENTAL IMPURITIES—LIMITS DRUG PRODUCTS/Large Volume Parenterals Second Supplement to USP35–NF30 5633 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
250
to:
10

<233> ELEMENTAL IMPURITIES—PROCEDURES INTRODUCTION/Definition Second Supplement to USP35–NF30 5634 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
Pd
to:
Pb

<698> DELIVERABLE VOLUME ACCEPTANCE CRITERIA/For Multiple-Unit Containers First Supplement to USP35–NF30 5154 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

ACETAZOLAMIDE FOR INJECTION ASSAY USP35–NF30 2063 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)

ADENOSINE IDENTIFICATION/Infrared Absorption <197M> USP35–NF30 2079 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 1:
Delete NMT 0.1%

Line 1:
Delete
NMT 0.1%

ALPRAZOLAM ORALLY-DISINTEGRATING TABLETS IMPURITIES/Procedure USP35–NF30 2106 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Change the subsection
Buffer and Diluent: Prepare as directed in the Assay.
to:
Diluent: Prepare as directed in the Assay.
Buffer: 6.8 g/L of monobasic potassium phosphate in water. Adjust with phosphoric acid to a pH of 3.0.

Change the subsection

Buffer and Diluent: Prepare as directed in the Assay.

to:

Diluent: Prepare as directed in the Assay.

Buffer: 6.8 g/L of monobasic potassium phosphate in
water. Adjust with phosphoric acid to a pH of 3.0.

AMOXICILLIN TABLETS PERFORMANCE TESTS USP35–NF30 2202 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 4 of Analysis: Change
Result = (rU/rS) × (CS/L) × (D/V) × P × F × 100
to:
Result = (rU/rS) × (CS/L) × V × D × P × F × 100
AND
Transpose lines 12 and 13 of the variable definition list to match the order in the equation

Line 4 of Analysis: Change

Result = (rU/rS) × (CS/L) × (D/V) × P × F × 100

to:

Result = (rU/rS) × (CS/L) × V × D × P × F × 100
AND

Transpose lines 12 and 13 of the variable definition list to match the order in the equation

AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Aminoazithromycin, Formamido Analog, Methylformamido Analog, and 3′-De(dimethylamino)-3′-oxoazithromycin Second Supplement to USP35–NF30 5910 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
3′-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin
to:
3′-N-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin

AZITHROMYCIN FOR INJECTION IMPURITIES/Limit of Azithromycin N-Oxide, Desosaminylazithromycin, and N-Demethylazithromycin Second Supplement to USP35–NF30 5910 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
Result = (rU/rS) × (CS/CU) × P × F × 100
to:
Result = (rU/rS) × (CS/CU) × P × 100

BENTONITE IDENTIFICATION/A. X-Ray Diffraction <941> USP35–NF30 1705 01-Oct-2012 USP37–NF32 First Supplement to USP36–NF31
Line 4 of Acceptance criteria: Change
from the pattern of Sample B is 1.492 and 1.504 Å.
to:
from the pattern of Sample B is between 1.492 and 1.504 Å.

Line 4 of Acceptance criteria: Change

from the pattern of Sample B is 1.492 and 1.504 Å.

to:

from the pattern of Sample B is between 1.492 and
1.504 Å.

XLS CSV