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

<1058> ANALYTICAL INSTRUMENT QUALIFICATION

ANALYTICAL INSTRUMENT QUALIFICATION PROCESS/Qualification Phases

First Supplement to USP40–NF35

8083 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of paragraph 1 of Operational Qualification: Change
OQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document.
to:
OQ demonstrates fitness for the selected use, and should reflect URS.
AND
Line 2 of paragraph 3 of Operational Qualification/Instrument Function Tests: Change
Holistic tests, which involve the entire system, demonstrate that the whole system complies with user specifications in the DQ.
to:
Holistic tests, which involve the entire system, demonstrate that the whole system complies with URS.







Line 2 of paragraph 1 of Operational Qualification: Change
OQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document.
to:
OQ demonstrates fitness for the selected use, and should reflect URS.
AND
Line 2 of paragraph 3 of Operational Qualification/Instrument Function Tests: Change
Holistic tests, which involve the entire system, demonstrate that the whole system complies with user specifications in the DQ.

Read more

ADAPALENE GEL

ASSAY/Procedure

First Supplement to USP39–NF34

7983 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 5 of Sample stock solution: Change
Cool to room temperature and dilute with Diluent to volume.
to:
Cool to room temperature and dilute with Mobile phase to volume.


Line 5 of Sample stock solution: Change
Cool to room temperature and dilute with Diluent to volume.
to:
Cool to room temperature and dilute with Mobile phase to volume.

ADENINE

CHEMICAL INFORMATION

USP39–NF34

2346 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2: Change
1H-Purin-6-amine;
to:
9H-Purin-6-amine;


Line 2: Change
1H-Purin-6-amine;
to:
9H-Purin-6-amine;

AMINOPHYLLINE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP40–NF35

2735 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65





Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65

AMINOPHYLLINE INJECTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP40–NF35

2737 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65





Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65

AMINOPHYLLINE ORAL SOLUTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP40–NF35

2739 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65





Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65

AMINOPHYLLINE TABLETS

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP40–NF35

2742 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65





Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65

AMINOPHYLLINE TABLETS

PERFORMANCE TESTS/Uniformity of Dosage Units <905>/Procedure for content uniformity

USP39–NF34

2483 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Variable definition for CU in Analysis: Change
(mg/mL)
to:
to:(µg/mL)


Variable definition for CU in Analysis: Change
(mg/mL)
to:
to:(µg/mL)

ATROPINE SULFATE

DEFINITION

USP39–NF34

2638 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2: Change
(C17H23NO32 · H2SO4),
to:
[(C17H23NO3)2 · H2SO4],


Line 2: Change
(C17H23NO32 · H2SO4),
to:
[(C17H23NO3)2 · H2SO4],

ATROPINE SULFATE

ASSAY/Procedure

USP39–NF34

2638 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 4 of Analysis: Change
(C17H23NO32 · H2SO4)
to:
[(C17H23NO3)2 · H2SO4]


Line 4 of Analysis: Change
(C17H23NO32 · H2SO4)
to:
[(C17H23NO3)2 · H2SO4]

BRINZOLAMIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

2788 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide oxalate.


Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide oxalate.

BRINZOLAMIDE OPHTHALMIC SUSPENSION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

2789 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide oxalate.


Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide oxalate.

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM

ASSAY/Procedure

USP39–NF34

3262 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

In the first variable definition list in Analysis: Change
CS = concentration of USP Clotrimazole RS in the Clotrimazole stock solution (mg/mL)
to:
CS = concentration of USP Clotrimazole RS in the Standard solution (mg/mL)
AND
In the second variable definition list in Analysis: Change
CS = concentration of USP Betamethasone Dipropionate RS in the Betamethasone dipropionate stock solution (mg/mL)
to:
CS = concentration of USP Betamethasone Dipropionate RS in the Standard solution (mg/mL)









In the first variable definition list in Analysis: Change
CS = concentration of USP Clotrimazole RS in the Clotrimazole stock solution (mg/mL)
to:
CS = concentration of USP Clotrimazole RS in the Standard solution (mg/mL)
AND
In the second variable definition list in Analysis: Change
CS = concentration of USP Betamethasone Dipropionate RS in the Betamethasone dipropionate stock solution (mg/mL)
to:
CS = concentration of USP Bet

Read more

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM

IMPURITIES/Organic Impurities: Limit of Clotrimazole Related Compound A

USP39–NF34

3262 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

In the variable definition list in Analysis: Change
CS = concentration of USP Clotrimazole Related Compound A RS in the Clotrimazole related compound A stock solution (mg/mL)
to:
CS = concentration of USP Clotrimazole Related Compound A RS in the Standard solution (mg/mL)


In the variable definition list in Analysis: Change
CS = concentration of USP Clotrimazole Related Compound A RS in the Clotrimazole related compound A stock solution (mg/mL)
to:
CS = concentration of USP Clotrimazole Related Compound A RS in the Standard solution (mg/mL)

CURCUMINOIDS

COMPOSITION/Content of Curcuminoids/Chromatographic system

USP39–NF34

6582 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

CURCUMINOIDS CAPSULES

STRENGTH/Content of Curcuminoids/Chromatographic system

USP39–NF34

6583 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

CURCUMINOIDS TABLETS

STRENGTH/Content of Curcuminoids/Chromatographic system

USP39–NF34

6585 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

EFAVIRENZ

IMPURITIES/Organic Impurities

USP39–NF34

3656 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Row 4 of Column 1 of Procedure 1/Impurity Table 1:Change
Efavirenz pent-3-ene-1-yne (cis)c
to:
Efavirenz pent-3-ene-1-yne (trans)c
AND
Row 5 of Column 1 of Procedure 1/Impurity Table 1:Change
Efavirenz pent-3-ene-1-yne (trans)d
to:
Efavirenz pent-3-ene-1-yne (cis)d
AND
Row 3 of Column 1 of Procedure 2/Impurity Table 2: Change
Efavirenz pent-3-ene-1-yne (cis)a
to:
Efavirenz pent-3-ene-1-yne (trans)a
AND
Row 4 of Column 1 of Procedure 2/Impurity Table 2:Change
Efavirenz pent-3-ene-1-yne (trans)b
to:
Efavirenz pent-3-ene-1-yne (cis)b

















Row 4 of Column 1 of Procedure 1/Impurity Table 1:Change
Efavirenz pent-3-ene-1-yne (cis)c
to:
Efavirenz pent-3-ene-1-yne (trans)c
AND
Row 5 of Column 1 of Procedure 1/Impurity Table 1:Change
Efavirenz pent-3-ene-1-yne (trans)d
to:
Efavirenz pent-3-ene-1-yne (cis)d
AND
Row 3 of Column 1 of Procedure 2/Impurity Table 2: Change
Efavirenz pent-3-ene-1-yne (cis)a
to:
Efavirenz pent-3-ene-1-yne (trans)a<

Read more

ENTECAVIR

ASSAY/Procedure

USP39–NF34

3704 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × (CS/CU) × 100
AND
Line 14 of Analysis: Delete
Mr1=molecular weight of anhydrous entecavir, 277.28
Mr2=molecular weight of entecavir, 295.29






Line 5 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
to:
Result = (rU/rS) × (CS/CU) × 100
AND
Line 14 of Analysis: Delete
Mr1=molecular weight of anhydrous entecavir, 277.28
Mr2=molecular weight of entecavir, 295.29

Read more

GALANTAMINE EXTENDED-RELEASE CAPSULES

PERFORMANCE TESTS/Dissolution <711>/Test 3

USP40–NF35

4367 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1of Buffer: Change
To each L of 6.8-g/L potassium phosphate
to:
To each L of 6.8 g/L of monobasic potassium phosphate


Line 1of Buffer: Change
To each L of 6.8-g/L potassium phosphate
to:
To each L of 6.8 g/L of monobasic potassium phosphate

HALCINONIDE

IMPURITIES/Organic Impurities/Chromatographic system

USP39–NF34

4175 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Column: Change
1.8-µm packing L1
to:
1.7-µm packing L1


Line 1 of Column: Change
1.8-µm packing L1
to:
1.7-µm packing L1

IMIPRAMINE PAMOATE CAPSULES

PERFORMANCE TESTS/Dissolution <711>/Test 1

Second Supplement to USP39–NF34

8681 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 6 of Analysis: Change
Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × V x (1/L) × 100
to:
Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × D × V × (1/L) × 100
AND
To the variable definition list in Analysis: Add
D = dilution factor of the Sample solution





Line 6 of Analysis: Change
Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × V x (1/L) × 100
to:
Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × D × V × (1/L) × 100
AND
To the variable definition list in Analysis: Add
D = dilution

Read more

LEVETIRACETAM EXTENDED-RELEASE TABLETS

PERFORMANCE TESTS/Dissolution <711>/Test 7

Revision Bulletin (Official October 01, 2016)

ONLINE 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of Standard solution: Change
Buffer A.
to:
Medium.


Line 2 of Standard solution: Change
Buffer A.
to:
Medium.

POWDERED TURMERIC

COMPOSITION/Content of Curcuminoids/Chromatographic system

USP39–NF34

6867 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

POWDERED TURMERIC EXTRACT

COMPOSITION/Content of Curcuminoids/Chromatographic system

USP39–NF34

6868 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

PROMETHAZINE HYDROCHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF34

8784 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88






Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88

PROMETHAZINE HYDROCHLORIDE INJECTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF34

8785 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88






Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88

PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF34

8787 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88






Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88

PROMETHAZINE HYDROCHLORIDE TABLETS

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF34

8788 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88






Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C17H20N2S · HCl 320.88

SODIUM CHLORIDE

IMPURITIES/Limit of Potassium/Instrumental conditions

Second Supplement to USP39–NF34

8821 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Mode: Change
Atomic absorption spectrophotometry
to:
Atomic emission spectroscopy


Line 1 of Mode: Change
Atomic absorption spectrophotometry
to:
Atomic emission spectroscopy

TACROLIMUS CAPSULES

PERFORMANCE TESTS/Dissolution <711>/Test 5

Second Supplement to USP39–NF34

8834 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Medium: Change
0.5 g/L
to:
0.05 g/L


Line 1 of Medium: Change
0.5 g/L
to:
0.05 g/L

TERAZOSIN TABLETS

ASSAY/Procedure

USP39–NF34

6045 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 3 of System suitability solution: Change
Standard solution
to:
Standard stock solution


Line 3 of System suitability solution: Change
Standard solution
to:
Standard stock solution

TERAZOSIN TABLETS

IMPURITIES/Organic Impurities/Procedure

USP39–NF34

6045 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Sample solution: Change
Transfer 15 mg of the powder from the crushed Tablets
to:
Transfer a suitable amount of powder, equivalent to 15 mg of terazosin hydrochloride, from the crushed Tablets


Line 1 of Sample solution: Change
Transfer 15 mg of the powder from the crushed Tablets
to:
Transfer a suitable amount of powder, equivalent to 15 mg of terazosin hydrochloride, from the crushed Tablets

TETRACYCLINE HYDROCHLORIDE

IMPURITIES/Organic Impurities

USP39–NF34

6080 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 16 of Analysis: Delete
Calculate the percentage of any unspecified impurity in the portion of Tetracycline Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response of any unspecified impurity from the Sample solution
rS = peak response of tetracycline from the Standard solution
CS = concentration of USP Tetracycline Hydrochloride RS in the Standard solution (µg/mL)
CU = concentration of Tetracycline Hydrochloride in the Sample solution (µg/mL)





Line 16 of Analysis: Delete
Calculate the percentage of any unspecified impurity in the portion of Tetracycline Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response of any unspecified impurity from the Sample solution
rS = peak response of tetracycline from the Standard solution
CS = concentration of USP Tetracycline Hydrochloride RS in the Standard soluti

Read more

THEOPHYLLINE

ADDITIONAL REQUIREMENTS/USP Reference Standards RS <11>

Second Supplement to USP39–NF34

8844 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 3 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65




Line 3 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65

THEOPHYLLINE ORAL SOLUTION

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF34

8846 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 3 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65




Line 3 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C6H10N4O · HCl · H2O 208.65

TURMERIC

COMPOSITION/Content of Curcuminoids/Chromatographic system

USP39–NF34

6866 01-Feb-2017

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;


Line 1 of Column: Change
4.6-mm × 20-cm;
to:
4.6-mm × 25-cm;

<1207> STERILE PRODUCT PACKAGING−INTEGRITY EVALUATION

5. PRODUCT–PACKAGE QUALITY REQUIREMENTS AND THE MAXIMUM ALLOWABLE LEAKAGE LIMIT/5.1 Sterility and Product Formulation Content must be Preserved; Gas Headspace Content Preservation is not Required

First Supplement to USP39–NF34

7764 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 3 of paragraph 5: Change
ultra-cold storage (<80°)
to:
ultra-cold storage (≤−80°)


Line 3 of paragraph 5: Change
ultra-cold storage (<80°)
to:
ultra-cold storage (≤−80°)

<661.1> PLASTIC MATERIALS OF CONSTRUCTION

TEST METHODS

USP40–NF35

542 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change
1.0 mg/mL of bromophenol blue,
to:
1.0 mg/mL of bromothymol blue,
AND
Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test B: Change
tris(2,4-di-tert-butylphenyl) phosphate;
to:
tris(2,4-di-tert-butylphenyl) phosphite;
AND
Line 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test C/Mobile phase: Change
(55:45:5, v/v/v)
to:
(50:45:5, v/v/v)
AND
Line 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Nonphenolic Antioxidants/Chromatographic system/Application: Change
20 µL of Sample solution S10, reference solution (o) and the reference solutions corresponding to
to:
20 µL of Sample solution S10 and the reference solutions corresponding to
AND
Line 2 of Plastic Additives/Plasticized Polyvinyl Chloride/USP Reference Standards <11>/USP Plastic Additive 05 RS: Change
Tris(2,4-di-tert-butylphenyl) phosphate.
to:
Tris(2,4-di-tert-butylphenyl) phosphite.  






















Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change
1.0 mg/mL of bromophenol blue,
to:
1.0 mg/mL of bromothymol blue,
AND
Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test B: Change
tris(2,4-di-tert-butylphenyl) phosphate;
to:
tris(2,4-di-tert-butylphenyl) phosphite;
AND
Line 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test C/Mob

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<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE

TEST METHODS/Physicochemical Tests/Water Extraction/Acidity or alkalinity

USP39–NF34

506 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of Methyl red TS 2: Change
NMT 0.1 mL of 0.02 N hydrochloric acid
to:
NMT 0.1 mL of 0.02 N sodium hydroxide


Line 2 of Methyl red TS 2: Change
NMT 0.1 mL of 0.02 N hydrochloric acid
to:
NMT 0.1 mL of 0.02 N sodium hydroxide

<670> AUXILIARY PACKAGING COMPONENTS

DESICCANTS/Silica Gel/Inorganic Impurities

USP39–NF34

510 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Soluble ionizable salts: Change
(as NaSO3):
to:
(as Na2SO4):


Line 1 of Soluble ionizable salts: Change
(as NaSO3):
to:
(as Na2SO4):

BETAXOLOL OPHTHALMIC SOLUTION

IMPURITIES/Organic Impurities

USP39–NF34

2749 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 14 of Analysis: Change
Mr1 = molecular weight of betaxolol hydrochloride, 343.89
Mr2 = molecular weight of betaxolol, 307.43
to:
Mr1 = molecular weight of betaxolol, 307.43
Mr2 = molecular weight of betaxolol hydrochloride, 343.89




Line 14 of Analysis: Change
Mr1 = molecular weight of betaxolol hydrochloride, 343.89
Mr2 = molecular weight of betaxolol, 307.43
to:
Mr1 = molecular weight of betaxolol, 307.43
Mr2 = molecular weight of betaxolol hydrochloride, 343.89

CARBIDOPA

ASSAY/Procedure

USP39–NF34

2924 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 3: Change
Mobile phase: Alcohol and 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7 (5:95)
to:
Buffer: 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7
Mobile phase: Alcohol and Buffer (5:95)



Line 3: Change
Mobile phase: Alcohol and 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7 (5:95)
to:
Buffer: 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7
Mobile phase: Alcohol and Buffer (5:95)

CHONDROITIN SULFATE SODIUM

IMPURITIES

USP39–NF34

6566 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Residue on Ignition <281>: Change
20.0%–30.0%
to:
20.0%–30.0% on the dried basis


Line 1 of Residue on Ignition <281>: Change
20.0%–30.0%
to:
20.0%–30.0% on the dried basis

CIPROFLOXACIN

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF34

8597 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3 · HCl 341.77




Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3 · HCl 341.77

CIPROFLOXACIN HYDROCHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Second Supplement to USP39–NF35

8600 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3 · HCl 341.77




Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C15H16FN3O3 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3 · HCl 341.77

CYCLOBENZAPRINE HYDROCHLORIDE

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

USP39–NF34

3333 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 2 of USP Cyclobenzaprine Related Compound B RS: Change
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine.
C19H19N 261.36
to:
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine hydrochloride.
C19H19N · HCl 297.82




Line 2 of USP Cyclobenzaprine Related Compound B RS: Change
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine.
C19H19N 261.36
to:
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine hydrochloride.
C19H19N · HCl 297.82

DESMOPRESSIN ACETATE

IDENTIFICATION/A. Mass Spectral Analysis

USP39–NF34

3387 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 6 of Instrumental conditions: Delete
Flow rate: 0.7 mL/min
Injection volume: 10 µL/min

Line 6 of Instrumental conditions: Delete
Flow rate: 0.7 mL/min
Injection volume: 10 µL/min

DEXTROSE

IDENTIFICATION/C. Water Determination <921>

Second Supplement to USP39–NF34

8612 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1: Change
Water Determination <921>
to:
Water Determination <921>, Method I


Line 1: Change
Water Determination <921>
to:
Water Determination <921>, Method I

DIGOXIN INJECTION

IDENTIFICATION/B.

USP39–NF34

3493 01-Dec-2016

USP41–NF36

Second Supplement to USP40–NF35

Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.


Line 1 of Procedure: Change
Proceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution.
to:
Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18).

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XLS CSV