Errata - English

Buffer solution—Transfer 2.72 g of sodium acetate trihydrate to a 2000-mL volumetric flask, add about 200 mL of water, and shake until dissolution is complete. Add 10.0 mL glacial acetic acid, dilute with water to volume, and mix. Mobile phase—Transfer 70.0 mL of acetonitrile to a 1000-mL volumetric flask, dilute with Buffer solution to volume, and mix. Degas, and filter before using. Make adjustments if necessary (see System Suitability under Chromatography 〈621〉). Internal standard solution—Transfer about 50 mg of theobromine, accurately weighed, to a 100-mL volumetric flask, dissolve in 10.0 mL of 6 N ammonium hydroxide, dilute with Mobile phase to volume, and mix. Standard preparation—Dissolve an accurately weighed quantity of USP Theophylline RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.1 mg of USP Theophylline RS per mL. Chromatographic system (see Chromatography 〈621〉)—The liquid chromatograph is equipped with a 280-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 1.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the theophylline and theobromine peaks is not less than 2.0, the tailing factor for the theophylline peak is not more than 2.0, and the relative standard deviation for replicate injections is not more than 1.5%. Procedure—Separately inject equal volumes (between 10 μL and 25 μL) of the Standard preparation and the Assay preparation into the chromatograph, and measure the peak responses for the major peaks. The retention time of theophylline relative to that of theobromine is about 1.6. Calculate the quantity, in mg, of anhydrous theophylline (C7H8N4O2) in the portion of Theophylline Sodium Glycinate taken by the formula: 2500C(RU / RS) in which C is the concentration, in mg per mL, of USP Theophylline RS in the Standard preparation, and RU and RS are the response ratios of the theophylline peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.

In Procedure: Related Peptides and Other Related Substances/Test 2: Change
Resolution solution:
to:
System suitability solution:
AND
In Procedure: Related Peptides and Other Related Substances/Test 2/Sample solution: Change
100 mL of Buffer C.
to:
100 μL of Buffer C.

In Organic Impurities/Table 4: Change
^a(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzyloxy)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro-4,6,9,11-tetrahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5-one.
to:
^a(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzoyloxy)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro-4,6,9,11-tetrahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5-one.

In Procedure for Potassium/Chromatographic system/Column: Change
4.6-mm × 25-cm; packing L97
to:
4-mm × 25-cm; packing L97
AND
In Procedure for Phosphate/Chromatographic system/Column: Change
4.6-mm × 25-cm; packing L103
to:
4-mm × 25-cm; packing L103

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.

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.

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 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 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 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.

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 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 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.

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