Errata - English

In A. HPTLC for Articles of Botanical Origin <203>/Sample solution: Change
Mix 50 mg of Cranberry Fruit Juice Dry Extract with 7 mL of water. Sonicate for 10 min at room temperature, centrifuge, and save the supernatant. Precondition an SPE cartridge (L2; 500 mg/6 mL) with 3 mL of methanol, and drain it with suction. Load 3 mL of water onto the cartridge and apply suction until the solvent reaches 1–2 mm above the top of the cartridge's stationary phase. Then load the cartridge with 1.5 mL of the supernatant, apply suction, and discard the eluate. Add 1 mL of a mixture of water and methanol (80:20). Load 1 mL of methanol and collect the eluate as the Sample solution.
to:
Mix 50 mg of Cranberry Fruit Juice Dry Extract with 7 mL of water. Sonicate for 10 min at room temperature, centrifuge, and save the supernatant. Precondition an SPE cartridge (L2; 500 mg/6 mL) with 3 mL of methanol, and drain it with suction. Load 3 mL of water onto the cartridge and apply suction until the solvent reaches 1–2 mm above the top of the cartridge's stationary phase. Then load the cartridge with 1.5 mL of the supernatant, apply suction, and discard the eluate. Add 1 mL of a mixture of water and methanol (80:20), apply suction, and discard the eluate. Load 1 mL of methanol and collect the eluate as the Sample solution.

In USP Reference Standards <11>/USP Nicardipine Related Compound B RS: Change
3-{2-[Benzyl(methyl)amino]ethyl}5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate oxalate.
to:
3-{2-[Benzyl(methyl)amino]ethyl} 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate oxalate.
AND
In USP Reference Standards <11>/USP Nicardipine Related Compound D RS: Change
Bis{2-[benzyl(methyl)amino]ethyl}2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride.
to:
Bis{2-[benzyl(methyl)amino]ethyl} 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride.

Change
White, crystalline wax. Freely soluble in water, in saline TS, and in dextrose solutions; very slightly soluble in alcohol; practically insoluble in chloroform and in ether. Insoluble in water and in most common organic solvents. NF category: Stiffening agent; lubricant; film-forming agent; release-modifying agent.
to:
White, crystalline wax. Insoluble in water and in most common organic solvents. NF category: Stiffening agent; lubricant; film-forming agent; release-modifying agent.

Change
Assay for neomycin—Proceed with Cream as directed in the Assay for neomycin under Neomycin and Polymyxin B Sulfates Cream.
Assay for polymyxin B—Proceed with Cream as directed in the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates Cream.
to:
Assay for neomycin—Proceed as directed under Antibiotics—Microbial Assays 〈81〉, using an accurately weighed portion of Cream, equivalent to about 1.75 mg of neomycin, shaken in a separator with about 50 mL of ether, and extracted with four 20-mL portions of Buffer B.3. Combine the aqueous extracts, and dilute with Buffer B.3 to an appropriate volume to obtain a stock solution of convenient concentration. Dilute this stock solution quantitatively and stepwise with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Assay for polymyxin B—Proceed as directed under Antibiotics—Microbial Assays 〈81〉, using an accurately weighed portion of Cream shaken with about 50 mL of ether in a separator, and extracted with four 25-mL portions of Buffer B.6. Combine the aqueous extracts, and dilute with Buffer B.6 to an appropriate volume to obtain a stock solution. Dilute this stock solution quantitatively and stepwise with Buffer B.6 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard (10 Polymyxin B Units per mL). Add to each test dilution of the Standard a quantity of USP Neomycin Sulfate RS, dissolved in Buffer B.6, to obtain the same concentration of neomycin present in the Test Dilution.

In Procedure/System suitability: Change
[Note—The relative retention times for acetanilide, cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.4, 0.8, 0.9, and 1.0, respectively.]
to:
[Note—The relative retention times for cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.8, 0.9, and 1.0, respectively.]

In Organic Impurities: Change
Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase and Chromatographic system: Proceed as directed in the Assay.
AND
Change
Standard solution: 1 µg/mL of metronidazole from USP Metronidazole RS and 2 µg/mL of tinidazole related compound A from USP Tinidazole Related Compound A RS in Mobile phase
to:
Standard solution: 1 µg/mL of metronidazole from USP Metronidazole RS and 2 µg/mL of tinidazole related compound A from USP Tinidazole Related Compound A RS in Mobile phase
Sample solution: Nominally 1 mg/mL of metronidazole prepared as follows. Mix the contents of Capsules (NLT 20). Transfer an amount equivalent to 100 mg of metronidazole to a 100-mL volumetric flask, add 80 mL of Mobile phase, and sonicate with intermittent shaking for 10 min. Shake for 30 min, and dilute with Mobile phase to volume. Centrifuge a portion of the solution.

In Organic Impurities, Procedure 1: Change
System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase, Diluent, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

In Organic Impurities/Standard solution: Change
isosorbide related compound A
to:
isosorbide mononitrate related compound A
AND
In System suitability/Suitability requirements/Relative standard deviation: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In four instances in Analysis: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In Table 1: Change
Isosorbide related compound A
to:
Isosorbide mononitrate related compound A

In Organic Impurities/Standard solution: Change
isosorbide related compound A
to:
isosorbide mononitrate related compound A
AND
In System suitability/Suitability requirements/Relative standard deviation: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In four instances in Analysis: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In Table 1: Change
Isosorbide related compound A
to:
Isosorbide mononitrate related compound A

In Dissolution 〈711〉/Standard solution: Change
USP Dapsone RS of a known concentration in Medium
to:
(L/1000) mg/mL of USP Dapsone RS in Medium, where L is the label claim in mg/Tablet. Transfer a portion of this solution containing 0.2 mg of dapsone to a 25-mL volumetric flask, add 5 mL of 1 N sodium hydroxide, and dilute with water to volume.

In USP Reference Standards 〈11〉: Change
USP Rivastigmine Tartrate R-Isomer RS
to:
USP Rivastigmine Tartrate R-Isomer RS
(R)-3-[1-(Dimethylamino)ethyl]phenyl ethylmethylcarbamate, hydrogen tartrate.
C₁₄H₂₂N₂O₂ · C₄H₆O₆ 400.42

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).

Change
Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Sterile Preparations <797>).
to:
Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Nonsterile Preparations <795>).

In B.: Change
The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

In Organic Impurities, Procedure 2/footnote 4: Change
5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl](acetylimino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hy droxypropyl]oxy]-2-hydroxypropyl](acetylimino)]-N,N'-bis(2,3-dihy droxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide.
to:
5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylamino)]-2-hydroxypropyl](acetylamino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hydroxypropyl]oxy]-2-hydroxypropyl](acetylamino)]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide.

In USP Reference Standards 〈11〉/USP Iodixanol Related Compound E RS: Change
5-[[3-[[3-[[(2,3-Dihydroxypropyl)amino]carbonyl]-5- [[amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl]-(acetylimino)]-N,N′-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide.
to:
5-{N-[3-(N-{3-Carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl}acetamido)-2-hydroxypropyl]acetamido}-N¹,N³-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide.

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.

In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change
Meets the requirements when tested as specified in test B.
to:
Meets the requirements of the test for amine hydrochlorides

Change
Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a test solution by shaking a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 1 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 〈621〉). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.

In Dissolution 〈711〉/Test 1/Analysis: Change
Result = (r_U/r_S) × C_S × V × (1/L) × 100
r_U = peak response of linezolid from the Sample solution
r_S = peak response of linezolid from the Standard solution
C_S = concentration of USP Linezolid RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
L = label claim (mg/Tablet)
to:
Result = (r_U/r_S) × C_S × V × (1/L) × D × 100
r_U = peak response of linezolid from the Sample solution
r_S = peak response of linezolid from the Standard solution
C_S = concentration of USP Linezolid RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
L = label claim (mg/Tablet)
D = dilution factor of the Sample solution, as needed

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 Acetic Acid in Peptides/Analysis: Change
C_SPA = concentration of potassium acetate in each of the Standard solutions (mg/mL)
to:
C_SPA = concentration of potassium acetate in each of the Standard solutions (µg/mL)
AND
In Ammonium/Analysis: Change
C_SAC = concentration of ammonium chloride in each of the Standard solutions (mg/mL)
to:
C_SAC = concentration of ammonium chloride in each of the Standard solutions (µg/mL)

In Dissolution 〈711〉/Test 2/Acid stage: Change
Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
to:
Acid stage standard solution: (L/10000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
AND
In Dissolution <711>/Test 2/Buffer stage: Change
Buffer stage standard solution: (L/1000) of USP Pantoprazole Sodium RS where L is the label claim in mg/Tablet
to:
Buffer stage standard solution: (L/1000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Buffer stage medium, where L is the label claim in mg/Tablet

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

Change
The solution obtained responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.