Errata - English

In Organic Impurities/Solution B: Change
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide TS to a pH of 6.0.
to:
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide solution to a pH of 6.0.
AND
In both equations in Organic Impurities/Analysis: Change
449.40
to:
449.39

In Dissolution 〈711〉/Test 1/Tier 1/Phosphate buffer, pH 7.5: Change
sodium hydroxide
to:
sodium hydroxide solution
AND
In Dissolution 〈711〉/Test 1/Tier 1/Analysis: Change
449.40
to:
449.39
AND
In Dissolution 〈711〉/Test 1/Tier 2/Solution A and Solution B: Change
sodium hydroxide
to:
sodium hydroxide solution
AND
In Dissolution 〈711〉/Test 2/Tier 2/Analysis: Change
449.40
to:
449.39
AND
In Dissolution 〈711〉/Test 3/Tier 2/Analysis: Change
449.40
to:
449.39

In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of 0.5 N hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.

In Organic Impurities/Table 3/footnote c: Change
2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]-2-hydroxypropyl methyl-L-valinate hydrochloride.
to:
3-[(2-Amino-6-oxo-1,6-dihydropurin-9-yl)methoxy]-2-hydroxypropyl L-valinate hydrochloride.

In Alcohol-Insoluble Matter/Sample solution: Change
100 mg/mL of Urea dissolved in warm alcohol
to:
Dissolve 5.0 g of Urea in 50 mL of warm alcohol.
AND
In Alcohol-Insoluble Matter/Analysis: Change
If any insoluble residue remains, pass the Sample solution through a tared filter, wash the residue and the filter with 20 mL of warm alcohol per 50 mL of Sample solution, and dry at 105° for 1 h.
to:
If any insoluble residue remains, pass the Sample solution through a tared filter, wash the residue and the filter with 20 mL of warm alcohol, and dry at 105° for 1 h.

In USP Tryptophan Related Compound A RS: Change
3,3′-[Ethylidenebis(1H-indole-1,3-diyl)]bis[2S)-2-aminopropanoic]acid.
C₂₄H₂₆N₄O₄ 432.49
to:
(2S,2'S)-3,3'-[Ethane-1,1-diylbis(1H-indole-1,3-diyl)]bis(2-aminopropanoic acid).
C₂₄H₂₆N₄O₄ 434.50

In USP Tioconazole Related Compound A RS: Change
389.73
to:
389.72
AND
In USP Tioconazole Related Compound B RS: Change
458.62
to:
458.60
AND
In USP Tioconazole Related Compound C RS: Change
C₁₆H₁₃BrCl₂N₂OS · HCl 468.63
to:
C₁₆H₁₂BrCl₃N₂OS · HCl 503.06

Change
A: The contents of the Capsules respond to Identification tests A and B under Theophylline Tablets.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
to:
A: Triturate a quantity of the contents of Capsules, equivalent to about 500 mg of theophylline, with 10-mL and 5-mL portions of solvent hexane, and discard the solvent hexane. Triturate the residue with two 10-mL portions of a mixture of equal volumes of 6 N ammonium hydroxide and water, and filter each time. Evaporate the combined filtrates to about 5 mL, neutralize, if necessary, with 6 N acetic acid, using litmus, and then cool to about 15°, with stirring. Collect the precipitate on a filter, wash it with cold water, and dry at 105° for 2 hours: the theophylline so obtained melts between 270° and 274° (see Melting Range or Temperature 〈741〉, Procedures, Procedure for Class I). Retain the remaining portion of the theophylline for use in Identification test B.
B: The IR absorption spectrum of a potassium bromide dispersion of the residue obtained in Identification test A exhibits maxima only at the same wavenumbers as that of a potassium bromide dispersion of USP Theophylline RS.
C: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Change
Where the label states tetracycline hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which tetracycline hydrochloride is used can be met.
to:
Where the label states Tetracycline Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Tetracycline Hydrochloride is used can be met.

Change
Where tetracycline hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.
to:
Where Tetracycline Hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.

In Procedure/System suitability/Suitability requirements: Change
Resolution: NLT 3 between telmisartan and telmisartan related compound A
Tailing factor: NMT 2.0 for the telmisartan peak
Capacity factor: NLT 1.5
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 3 between telmisartan and telmisartan related compound A
Tailing factor: NMT 2.0 for telmisartan
Relative standard deviation: NMT 2.0% for telmisartan

In Dissolution 〈711〉/Test 1/Analysis: Change
Determine the percentage of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U × C_S × V × 100)/(A_S × D × L)
to:
Calculate the percentage of the labeled amount of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U/A_S) × C_S × V × D × (1/L) × 100
AND
Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)
AND
In Dissolution 〈711〉/Test 2/Analysis: Change
r_U = peak response from the Sample solution
r_S = peak response from the Standard solution
to:
r_U = peak response of telmisartan from the Sample solution
r_S = peak response of telmisartan from the Standard solution
AND
In Dissolution 〈711〉/Test 3/Analysis: Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)

In Organic Impurities/System suitability: Change
Sample: Standard solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0
Relative standard deviation: NMT 5.0%
Signal-to-noise ratio: NLT 10
to:
Samples: Standard solution and Sensitivity solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 5.0%, Standard solution
Signal-to-noise ratio: NLT 10, Sensitivity solution

In Sulfite/Analysis/footnote 1: Change
Test kit for sulfite determination may be ordered from the following suppliers: Megazyme Ltd. (Product code: K-ETSULPH); R-Biopharm (Enzytec) (Article No.: E6275); BioSenTec/Nzytech (Catalogue No.: AK00071).
to:
Test kit for sulfite determination may be ordered from the following suppliers: Megazyme Ltd. (Product code K-ETSULPH); R-Biopharm (Enzytec) (Article No. E6275); Nzytech (Catalogue No. AK00071) and BioSenTec (Product reference 040-E).

In Analysis: Change
Calculate the percentage of any unspecified impurities in the portion of Sotalol Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × 100
r_U= sum of all the peak responses of all unspecified impurities from the Sample solution
to:
Calculate the percentage of any unspecified impurity in the portion of Sotalol Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × 100
r_U = peak response of each unspecified impurity from the Sample solution
AND
In Table 1: Change
Any unspecified impurities
to:
Any unspecified impurity

Change
523.32
to:
523.33
AND
Change
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate
to:
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate

Change
Where the label states that Seco barbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and for Bacterial endotoxins under Secobarbital Sodium for Injection. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Secobarbital Sodium for Injection.
to:
Where the label states that Secobarbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>.

In Standard solution B: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,
AND
In Sample solution: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,

In Buffer stage/Analysis: Change
Calculate the percentage of the labeled amount of risedronate sodium (C₇H₁₀NNaO₇P₇) dissolved:
to:
Calculate the percentage of the labeled amount of risedronate sodium (C₇H₁₀NNaO₇P₂) dissolved:

Change
847.00
to:
847.02
AND
Change
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2′,3′:7,8]naphth[1,2-d]imidazole-2,4′-piperidine]-5,10,26-(3H,9H)-trione-16-acetate
to:
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,18,20-Trihydroxy-1’-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-5,10,26-trioxo-3,5,9,10-tetrahydrospiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2’,3’:7,8]naphtho[1,2-d]imidazole-2,4’-piperidin]-16-yl acetate

Change
Prepare this solution by one of the following procedures:
to:
Prepare this solution by one of the following procedures. Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions or commercially bought solutions.
AND
In Storage: Delete
Use the Test for sensitivity to confirm suitability for use.
AND
In Procedure with No Preservative: Delete
Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions.
AND
In Test for sensitivity: Delete
Use the Test for sensitivity to confirm suitability for use.
AND
In Procedure with Salicylic Acid as Preservative: Change
Mix 1 g of soluble starch with 50 mL of cold water
to:
Mix 1 g of soluble starch with 5 mL of cold water

In Leachable Arsenic/Analysis: Change
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure.
to:
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure 1.

Change
Uniformity of Dosage Units 〈905〉
Procedure for content uniformity
to:
Uniformity of Dosage Units 〈905〉: Meets the requirements
Procedure for content uniformity, chewable tablets only
AND
In Uniformity of Dosage Units: Delete
Acceptance criteria: Meet the requirements for chewable tablets

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

In Analysis: Change
Results = (A_U/A_S) × C_S × D × (1/L) × V × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
D = dilution factor for Sample solution, if needed
L = label claim (mg/Tablet)
V = volume of Medium, 500 mL
to:
Result = (A_U/A_S) × C_S × V × D × (M_r1/M_r2) × (1/L) × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
V = volume of Medium, 500 mL
D = dilution factor for the Sample solution, if needed
M_r1 = molecular weight of prochlorperazine, 373.94
M_r2 = molecular weight of prochlorperazine maleate, 606.09
L = label claim (mg/Tablet)

In Analysis: Change
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL)
C_U = nominal concentration of prazosin in the Sample solution (µg/mL)
M_r1 = molecular weight of prazosin, 383.41
M_r2 = molecular weight of prazosin hydrochloride, 419.86
to:
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (mg/mL)
C_U = nominal concentration of prazosin in the Sample solution (mg/mL)
M_r1 = molecular weight of prazosin, 383.41
M_r2 = molecular weight of prazosin hydrochloride, 419.87