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.
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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description

<1724> SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS

IN VITRO PERFORMANCE TESTS

USP39–NF34

1869 01-Jun-2016

USP40–NF35

USP40–NF35

Line 7 of Application of Drug Release: Change
The individual amounts of drug released from R is plotted versus time,
to:
The individual amounts of drug released from R are plotted versus the square root of time,


Line 7 of Application of Drug Release: Change
The individual amounts of drug released from R is plotted versus time,
to:
The individual amounts of drug released from R are plotted versus the square root of time,

<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS

5. FACILITIES AND ENGINEERING CONTROLS/5.3 Compounding

First Supplement to USP39–NF34

7721 01-Jun-2016

USP40–NF35

USP40–NF35

First bullet in second paragraph: Change
• Be externally vented through high-efficiency particulate air (HEPA) filtration
to:
• Be externally vented


First bullet in second paragraph: Change
• Be externally vented through high-efficiency particulate air (HEPA) filtration
to:
• Be externally vented

ALPRAZOLAM EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>

USP39–NF34

2389 01-Jun-2016

USP40–NF35

USP40–NF35

Variable definition list of second equation in Test 2/Analysis: Change
VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
VS = volume of the Sample solution withdrawn at each time point (mL)
AND
Variable definition list of second equation in Test 3/Analysis: Change
VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
VS = volume of the Sample solution withdrawn at each time point (mL)







Variable definition list of second equation in Test 2/Analysis: Change
VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
VS = volume of the Sample solution withdrawn at each time point (mL)
AND
Variable definition list of second equation in Test 3/Analysis: Change
VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
VS = volume of the

Read more

BACITRACIN ZINC

IMPURITIES

USP39–NF34

2674 01-Jun-2016

USP40–NF35

USP40–NF35

Delete the Residue on Ignition <281> test.

Delete the Residue on Ignition <281> test.

CETYL ALCOHOL

IMPURITIES/Limit of Related Fatty Alcohols

USP39–NF34

7239 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Sample solution: Change
1 mg/mL of Cetyl Alcohol in ethanol
to:
Prepare 1.0 mg/mL of Cetyl Alcohol in ethanol, and heat the solution in a sealed container in a 50° water bath until cetyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.


Line 1 of Sample solution: Change
1 mg/mL of Cetyl Alcohol in ethanol
to:
Prepare 1.0 mg/mL of Cetyl Alcohol in ethanol, and heat the solution in a sealed container in a 50° water bath until cetyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.

CHONDROITIN SULFATE SODIUM, SHARK

IMPURITIES/Limit of Protein

USP39–NF34

6570 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of Instrumental conditions: Change
(See Spectrophotometry and Light-Scattering <851>.)
to:
(See Ultraviolet-Visible Spectroscopy <857>.)


Line 2 of Instrumental conditions: Change
(See Spectrophotometry and Light-Scattering <851>.)
to:
(See Ultraviolet-Visible Spectroscopy <857>.)

CHONDROITIN SULFATE SODIUM, SHARK

COMPOSITION/Disaccharide Composition

USP39–NF34

6570 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of Chondroitinase ABC solution: Change
10.0 mL of Buffer solution
to:
1.0 mL of Buffer solution
AND
Line 4 of Analysis: Change
and 1.0 mL
to:
and 0.1 mL







Line 2 of Chondroitinase ABC solution: Change
10.0 mL of Buffer solution
to:
1.0 mL of Buffer solution
AND
Line 4 of Analysis: Change
and 1.0 mL
to:
and 0.1 mL

CHONDROITIN SULFATE SODIUM, SHARK

SPECIFIC TESTS/Clarity and Color of Solution

USP39–NF34

6570 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of Instrumental conditions: Change
(See Spectrophotometry and Light-Scattering <851>.)
to:
(See Ultraviolet-Visible Spectroscopy <857>.)


Line 2 of Instrumental conditions: Change
(See Spectrophotometry and Light-Scattering <851>.)
to:
(See Ultraviolet-Visible Spectroscopy <857>.)

DIAZEPAM INJECTION

Assay

USP39–NF34

3445 01-Jun-2016

USP40–NF35

USP40–NF35

Line 7 of Procedure:
50C / V(RU / RS)
to:
50(C / V)(RU / RS)


Line 7 of Procedure:
50C / V(RU / RS)
to:
50(C / V)(RU / RS)

DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS

IMPURITIES/Organic Impurities

USP39–NF34

3460 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Standard solution: Change
0.001 mg/mL of USP Diclofenac Sodium RS in Diluent
to:
0.001 mg/mL each of USP Diclofenac Sodium RS and USP Diclofenac Related Compound A RS in Diluent


Line 1 of Standard solution: Change
0.001 mg/mL of USP Diclofenac Sodium RS in Diluent
to:
0.001 mg/mL each of USP Diclofenac Sodium RS and USP Diclofenac Related Compound A RS in Diluent

IMIQUIMOD CREAM

IMPURITIES/Organic Impurities

USP39–NF34

4289 01-Jun-2016

USP40–NF35

USP40–NF35

Row 2 of Column 3 of Table 2: Change
1.5
to:
1.15
AND
Row 3 of Column 3 of Table 2: Change
1.15
to:
1.5







Row 2 of Column 3 of Table 2: Change
1.5
to:
1.15
AND
Row 3 of Column 3 of Table 2: Change
1.15
to:
1.5

LORAZEPAM

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4618 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of USP Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO


Line 3 of USP Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO

LORAZEPAM INJECTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4620 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO


Line 3 of Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO

LORAZEPAM ORAL CONCENTRATE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

4621 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO


Line 3 of Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO

LORAZEPAM TABLETS

ADDITIONAL REQUIREMENTS/USP Reference Standards RS <11>

USP39–NF34

4622 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of USP Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO


Line 3 of USP Lorazepam Related Compound B RS: Change
C13H9ClNO
to:
C13H9Cl2NO

METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>

USP39–NF34

4766 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Test 3: Change
Medium, Apparatus 1, Apparatus 2, and Analysis:
to:
Medium, Apparatus 1, and Apparatus 2:


Line 3 of Test 3: Change
Medium, Apparatus 1, Apparatus 2, and Analysis:
to:
Medium, Apparatus 1, and Apparatus 2:

MYCOPHENOLATE SODIUM

ASSAY/Procedure

USP39–NF34

4965 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3: Change
Solvent A
to:
Solution A
AND
Line 5: Change
Solvent B
to:
Solution B







Line 3: Change
Solvent A
to:
Solution A
AND
Line 5: Change
Solvent B
to:
Solution B

MYRISTYL ALCOHOL

ASSAY/Procedure

USP39–NF34

7413 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Myristyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of Myristyl Alcohol in Internal standard solution







Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved.

Read more

NALTREXONE HYDROCHLORIDE

Related compounds

USP39–NF34

4985 01-Jun-2016

USP40–NF35

USP40–NF35

Line 5: Change
10F(C/W)(rU / rS)
to:
1000F(C/W)(rU/rS)


Line 5: Change
10F(C/W)(rU / rS)
to:
1000F(C/W)(rU/rS)

NICOTINE POLACRILEX

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

5061 01-Jun-2016

USP40–NF35

USP40–NF35

Add
USP Polacrilex Resin RS

Add
USP Polacrilex Resin RS

OLEYL ALCOHOL

ASSAY/Procedure

USP39–NF34

7424 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Oleyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of Oleyl Alcohol in Internal standard solution







Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Oleyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved.

Read more

OXANDROLONE TABLETS

Dissolution <711>/Test 3

USP39–NF34

5193 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Chromatographic system: Change
30-cm column
to:
3-cm column


Line 3 of Chromatographic system: Change
30-cm column
to:
3-cm column

PALIPERIDONE

CHEMICAL INFORMATION

USP39–NF34

5253 01-Jun-2016

USP40–NF35

USP40–NF35

Line 5: Change
(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido [1,2-a]pyrimidin-4-one
to:
(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one


Line 5: Change
(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido [1,2-a]pyrimidin-4-one
to:
(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one

PALIPERIDONE

IMPURITIES/Organic Impurities/System suitability/Suitability requirements

USP39–NF34

5253 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of Resolution: Change
hydroxybenzyl
to:
hydroxybenzoyl


Line 3 of Resolution: Change
hydroxybenzyl
to:
hydroxybenzoyl

PAROXETINE EXTENDED-RELEASE TABLETS

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

First Supplement to USP39–NF34

8121 01-Jun-2016

USP40–NF35

USP40–NF35

USP Paroxetine Related Compound B RS: Add
C19H21NO3 · HCl 347.84

USP Paroxetine Related Compound B RS: Add
C19H21NO3 · HCl 347.84

RANITIDINE IN SODIUM CHLORIDE INJECTION

USP Reference standards <11>

USP39–NF34

5673 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.


Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

RANITIDINE INJECTION

USP Reference standards <11>

USP39–NF34

5670 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.


Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

RANITIDINE ORAL SOLUTION

USP Reference standards <11>

USP39–NF34

5671 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.


Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

RANITIDINE TABLETS

USP Reference standards <11>

USP39–NF34

5672 01-Jun-2016

USP40–NF35

USP40–NF35

Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.


Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

REAGENTS, INDICATORS AND SOLUTIONS

REAGENTS/6. General Tests for Reagents/6.2 Amino Nitrogen Test in Reagents

USP39–NF34

2080 01-Jun-2016

USP40–NF35

USP40–NF35

In the numerator of the equation: Change
2.8
to:
14
AND
Add
× f
AND
Line 10: Change
where %LOD is the percentage of loss on drying.
to:
where f is the correction factor obtained in the standardization of 0.2 N sodium hydroxide and %LOD is the percentage of loss on drying.










In the numerator of the equation: Change
2.8
to:
14
AND
Add
× f
AND
Line 10: Change
where %LOD is the percentage of loss on drying.
to:
where f is the correction factor obtained in the standardization of 0.2 N sodium hydroxide and %LOD is the percentage of loss on drying.

SAMARIUM Sm 153 LEXIDRONAM INJECTION

Other requirements

USP39–NF34

5791 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1: Change
Injections and Implanted Drug Products <1>; not subject to Container Content.
to:
Meets the requirements of Injections and Implanted Drug Products <1>; not subject to Container content.


Line 1: Change
Injections and Implanted Drug Products <1>; not subject to Container Content.
to:
Meets the requirements of Injections and Implanted Drug Products <1>; not subject to Container content.

SODIUM CETOSTEARYL SULFATE

IMPURITIES/Limit of Sodium Chloride and Sodium Sulfate/Sodium sulfate/Titrimetric system

USP39–NF34

7518 01-Jun-2016

USP40–NF35

USP40–NF35

Line 1 of Endpoint detection: Change
Potentiometric
to:
Visual


Line 1 of Endpoint detection: Change
Potentiometric
to:
Visual

TETRACYCLINE HYDROCHLORIDE CAPSULES

ASSAY/Procedure

USP39–NF34

6082 01-Jun-2016

USP40–NF35

USP40–NF35

Line 6 of Sample solution: Change
dilute with Diluent to volume.
to:
dilute with Solution A to volume.


Line 6 of Sample solution: Change
dilute with Diluent to volume.
to:
dilute with Solution A to volume.

TROSPIUM CHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

6287 01-Jun-2016

USP40–NF35

USP40–NF35

Line 3 of USP Trospium Chloride Related Compound C RS:Change
(1R,3r,5S)-3-Hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium] chloride.
to:
(1R,3r,5S)-3-Hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium] chloride, or (1R,3r,5S)-3-Hydroxyspiro[bicyclo[3.2.1]octane-8,1′-pyrrolidin]-1′-ium chloride.


Line 3 of USP Trospium Chloride Related Compound C RS:Change
(1R,3r,5S)-3-Hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium] chloride.
to:
(1R,3r,5S)-3-Hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium] chloride, or (1R,3r,5S)-3-Hydroxyspiro[bicyclo[3.2.1]octane-8,1′-pyrrolidin]-1′-ium chloride.

VINPOCETINE

IMPURITIES/Organic Impurities

USP39–NF34

6880 01-Jun-2016

USP40–NF35

USP40–NF35

Footnote a of Table 1: Change
Ethyl (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate).
to:
Ethyl (12S,13aS,13bS)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate).
AND
Footnoteb of Table 1: Change
Methyl (13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (apovincamine).
to:
Methyl (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (apovincamine).
AND
Footnote d of Table 1: Change
Ethyl (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine).
to:
Ethyl (12R,13aS,13bS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine).












Footnote a of Table 1: Change
Ethyl (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate).
to:
Ethyl (12S,13aS,13bS)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate).
AND
Footnoteb of Table 1: Change
Methyl (13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro

Read more

<1132> RESIDUAL HOST CELL PROTEIN MEASUREMENT IN BIOPHARMACEUTICALS

4. HCP IMMUNOASSAY METHOD VALIDATION/4.3 Sample Linearity/Table 4

Second Supplement to USP38–NF33

7647 01-Apr-2016

USP40–NF35

USP40–NF35

Product column: Change
10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16
to:
10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625
AND
Sample 1/HCP ratio column: Change
4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6
to:
4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6
AND
Sample 2/HCP ratio column: Change
2.0, 3.3, 4.0, 5.9, 5.3, 6.1, <6
to:
2.00, 3.30, 4.00, 5.92, 5.28, 6.08, <6
AND
Sample 3/HCP ratio column: Change
0.3, 0.5, 0.6, 0.9, 1.4, <6, <6
to:
0.32, 0.50, 0.60, 0.88, 1.44, <6, <6
AND
Sample 3/% max ratio value column: Change
83%
to:
61%






















Product column: Change
10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16
to:
10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625
AND
Sample 1/HCP ratio column: Change
4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6
to:
4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6
AND
Sample 2/HCP ratio column: Change
2.0, 3.3, 4.0, 5.9, 5.3, 6.1, <6
to:
2.00, 3.30, 4.00, 5.92, 5.28, 6.08, <6
AND
Sample 3/HCP ratio column: Change
0.3, 0.5, 0.6, 0.9, 1.4, <6, <6
to:
0.32, 0.50, 0.60, 0.88, 1.44, <6, <6
AN

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<661.1> PLASTIC MATERIALS OF CONSTRUCTION

SPECIFICATIONS/Polyethylene/Extractable Metals

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of Zirconium: Change
1 µg/g.
to:
0.1 µg/g.


Line 1 of Zirconium: Change
1 µg/g.
to:
0.1 µg/g.

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

TEST METHODS/Physicochemical Tests/Absorbance

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Line 3 of Plasticized polyvinyl chloride: Delete
Additionally, for nonplasticized polyvinyl chloride materials only, determine the spectrum between 250 and 330 nm in the alcohol sample associated with Solution S6.

Line 3 of Plasticized polyvinyl chloride: Delete
Additionally, for nonplasticized polyvinyl chloride materials only, determine the spectrum between 250 and 330 nm in the alcohol sample associated with Solution S6.

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

TEST METHODS/Extractions/Table 3

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of footnote b: Change
For nonplasticized polyethylene only.
to:
For polyethylene only.


Line 1 of footnote b: Change
For nonplasticized polyethylene only.
to:
For polyethylene only.

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

TEST METHODS/Extractions/Table 3

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Column 4 of S3 row: Change
Extractable metals: Al, Sb, As, Ba, Cd, Co, Ge, Hg, Mn, Ni, Pb, Ti, V, and Zn
to:
Extractable metals: Al, As, Ba, Cd, Co, Hg, Mn, Ni, Pb, Ti, V, and Zn


Column 4 of S3 row: Change
Extractable metals: Al, Sb, As, Ba, Cd, Co, Ge, Hg, Mn, Ni, Pb, Ti, V, and Zn
to:
Extractable metals: Al, As, Ba, Cd, Co, Hg, Mn, Ni, Pb, Ti, V, and Zn

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

SPECIFICATIONS/Polyethylene Terephthalate and Polyethylene Terephthalate G/Extractable Metals

USP39–NF34

493 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of Titanium: Change
0.1 µg/g.
to:
1 µg/g.


Line 1 of Titanium: Change
0.1 µg/g.
to:
1 µg/g.

<671> CONTAINERS--PERFORMANCE TESTING

MOISTURE VAPOR TRANSMISSION/Packaging System Classification for Multiple-Unit Containers and Unit-Dose Containers for Liquid Oral Dosage Forms/Procedure

USP38–NF33

465 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of the Equation: Change
[(W1iWT) − (W14iWT) − (WC1WC14)] × 365 × {[100/(W1iWT)] × 14}
to:
[(W1iWT) − (W14iWT) − (WC1WC14)] × 365 × 100/(W1i WT) × 14


Line 1 of the Equation: Change
[(W1iWT) − (W14iWT) − (WC1WC14)] × 365 × {[100/(W1iWT)] × 14}
to:
[(W1iWT) − (W14iWT) − (WC1WC14)] × 365 × 100/(W1i WT) × 14

<711> DISSOLUTION

INTERPRETATION/Immediate-Release Dosage Forms/Immediate-Release Dosage Forms Pooled Sample

USP39–NF34

540 01-Apr-2016

USP40–NF35

USP40–NF35

Row 3 of Column 1 of Acceptance Table for a Pooled Sample: Change
S1
to:
S2
AND
Row 4 of Column 1 of Acceptance Table for a Pooled Sample: Change
S1
to:
S3







Row 3 of Column 1 of Acceptance Table for a Pooled Sample: Change
S1
to:
S2
AND
Row 4 of Column 1 of Acceptance Table for a Pooled Sample: Change
S1
to:
S3

ARGININE HYDROCHLORIDE

SPECIFIC TESTS/Chloride Content

USP38–NF33

2279 01-Apr-2016

USP40–NF35

USP40–NF35

Delete the subsection
Blank: 140 mL of water and 1 mL of dichlorofluorescein TS
AND
The equation in the Analysis: Change
Result = [(VB) × N × F × 100]/W
to:
Result = (V × N × F × 100)/W
AND
Line 10 of Analysis: Delete
B = Blank titrant volume (mL)








Delete the subsection
Blank: 140 mL of water and 1 mL of dichlorofluorescein TS
AND
The equation in the Analysis: Change
Result = [(VB) × N × F × 100]/W
to:
Result = (V × N × F × 100)/W
AND
Line 10 of Analysis: Delete
B = Blank titrant volume (mL)

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS

IMPURITIES/Organic Impurities

USP39–NF34

2895 01-Apr-2016

USP40–NF35

USP40–NF35

Row 3 of Column 1 of Table 6:Change
Candesartan related compound Ab,c
to:
Candesartan cilexetil related compound Ab,c


Row 3 of Column 1 of Table 6:Change
Candesartan related compound Ab,c
to:
Candesartan cilexetil related compound Ab,c

DIGOXIN

IMPURITIES/Related Glycosides/System suitability

Interim Revision Announcement (Official November 01, 2015)

ONLINE 01-Apr-2016

USP40–NF35

USP40–NF35

Line 2: Change
Sample: System suitability solution
to:
Samples: System suitability solution and Standard solution
AND
Line 2 of Suitability requirements: Change
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections
to:
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks, System suitability solution
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections, Standard solution









Line 2: Change
Sample: System suitability solution
to:
Samples: System suitability solution and Standard solution
AND
Line 2 of Suitability requirements: Change
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections
to:
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks, System suitability solution
Relative standard deviation: NMT 2.0%, determined from the digoxin peak

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DIPHENHYDRAMINE HYDROCHLORIDE INJECTION

ASSAY/Procedure

USP39–NF34

3529 01-Apr-2016

USP40–NF35

USP40–NF35

Line 1 of System suitability solution:Change
USP Diphenhydramine Hydrochloride Related Compound A RS
to:
USP Diphenhydramine Related Compound A RS
AND
Line 4 of System suitability: Change
for diphenhydramine hydrochloride related compound A and diphenhydramine hydrochloride are
to:
for diphenhydramine related compound A and diphenhydramine are







Line 1 of System suitability solution:Change
USP Diphenhydramine Hydrochloride Related Compound A RS
to:
USP Diphenhydramine Related Compound A RS
AND
Line 4 of System suitability: Change
for diphenhydramine hydrochloride related compound A and diphenhydramine hydrochloride are
to:
for diphenhydramine related compound A and diphenhydramine are

FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER

ASSAY/Procedure

USP39–NF34

4020 01-Apr-2016

USP40–NF35

USP40–NF35

Line 3 of System suitability: Change
for salmeterol and fluticasone propionate are
to:
for fluticasone propionate and salmeterol are


Line 3 of System suitability: Change
for salmeterol and fluticasone propionate are
to:
for fluticasone propionate and salmeterol are

MEMANTINE HYDROCHLORIDE TABLETS

IMPURITIES/Organic Impurities

Revision Bulletin (Official October 01, 2015)

ONLINE 01-Apr-2016

USP40–NF35

USP40–NF35

Line 3 of Analysis: Change
of USP Memantine Related Compound E RS or
to:
of memantine related compound E or
AND
In the variable definition list: Change
rU = peak response of USP Memantine Related Compound E RS or any individual degradation product from the Sample solution
to:
rU = peak response of memantine related compound E or any individual degradation product from the Sample solution







Line 3 of Analysis: Change
of USP Memantine Related Compound E RS or
to:
of memantine related compound E or
AND
In the variable definition list: Change
rU = peak response of USP Memantine Related Compound E RS or any individual degradation product from the Sample solution
to:
rU = peak response of memantine related compound E or any individual degradation product from the Sample solution

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

IMPURITIES/Limit of Methacrylic Acid and Ethyl Acrylate

First Supplement to USP39–NF34

ONLINE 01-Apr-2016

USP40–NF35

USP40–NF35

Line 5 of Standard solution: Change
Mix 10.0 mL of this solution
to:
Mix 5.0 mL of this solution
AND
Line 7 of Standard solution: Change
about 0.67 µg/mL
to:
about 0.5 µg/mL
Line 4 of Sample solution: Change
10.0 mL of this solution
to:
5.0 mL of this solution
AND
In the variable definition list in Analysis: Change
VF = final volume of the Sample solution, 15 mL
D = dilution factor for preparation of the Sample solution, 5
to:
VF = final volume of the Sample solution, 10 mL
D = dilution factor for preparation of the Sample solution, 10


















Line 5 of Standard solution: Change
Mix 10.0 mL of this solution
to:
Mix 5.0 mL of this solution
AND
Line 7 of Standard solution: Change
about 0.67 µg/mL
to:
about 0.5 µg/mL
Line 4 of Sample solution: Change
10.0 mL of this solution
to:
5.0 mL of this solution
AND
In the variable definition list in Analysis: Change
VF = final volume of the Sample solution, 15 mL
D = dilution factor for preparation of the Sample solution, 5
to:
VF =

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