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Printed by: USP NF Official Date: Official as of 01-Aug-2022 Document Type: USP @2024 USPC
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containing 500 mL of Solution C. Continue the heating and
Basic Fuchsin nitrogen flow, and while stirring, titrate with titrant to a
yellow endpoint.
Calculate the percentage of rosaniline hydrochloride
(C20H19N3 · HCl) in the portion of Basic Fuchsin taken:
Result = [(V × N × F)/W] × 100
V = Titrant volume consumed by the Sample (mL)
Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5- N = Titrant normality (mEq/mL)
cyclohexadien-1-ylidene)methyl-2-methyl]-, F = equivalency factor, 67.58 mg/mEq
monohydrochloride; W = Sample weight (mg)
C.I. Basic Violet 14 monohydrochloride CAS RN®: 632-99-5.
Acceptance criteria: NLT 88.0% on the dried basis
DEFINITION
Basic Fuchsin is a mixture of rosaniline and pararosaniline IMPURITIES
hydrochlorides. It contains the equivalent of NLT 88.0% of • ALCOHOL-INSOLUBLE SUBSTANCES
rosaniline hydrochloride (C20H19N3 · HCl), calculated on the Sample: 1 g
dried basis. Analysis: Boil the Sample with 50 mL of alcohol under a
reflux condenser for 15 min, and filter through a tared
IDENTIFICATION filtering crucible. Wash the residue on the filter with hot
• A. alcohol until the washings cease to be colored violet, and
Sample solution: 1 mg/mL dry the crucible at 105° for 1 h.
al
Analysis: To 5 mL of the Sample solution, add a few drops of Acceptance criteria: The amount of insoluble residue is
hydrochloric acid. NMT 1.0%.
Acceptance criteria: A yellow color is produced (distinction • RESIDUE ON IGNITION á281ñ
from acid fuchsin). Sample: 1 g
• B. ci Analysis: Ignite the Sample with 0.5 mL of sulfuric acid.
Sample solution: 2 mg/mL Acceptance criteria: NMT 0.3%.
Analysis: To 5 mL of the Sample solution, add a few drops of
tannic acid TS. Delete the following:
Acceptance criteria: A red precipitate is formed.
• C.
▲
• ARSENIC á211ñ, Procedures, Method II: 8 ppm▲ (USP 1-Aug-2022)
Sample solution: 2 mg/mL
ffi
Analysis: To 10 mL of the Sample solution, add 10 mL of Delete the following:
ammonia TS and 500 mg of zinc dust, and agitate the
mixture. The solution becomes decolorized. Place a few
▲
• LEAD á251ñ
drops of the decolorized solution on filter paper, and Sample solution: Place 1 g of Basic Fuchsin in a small
nearby on the same paper, place a few drops of 3 N Kjeldahl flask, add 5 mL of sulfuric acid, and insert a small
hydrochloric acid. funnel into the flask. Gently rotate the flask until the sulfuric
O
Acceptance criteria: A red color develops at the zone of acid has completely wetted the Basic Fuchsin, then heat
contact. with a small flame until carbonization is complete. Allow to
cool, and add, in small quantities, 5 mL of nitric acid. Again
ASSAY heat gently until fumes of sulfur trioxide are evolved. Allow
• PROCEDURE to cool, add another 5 mL of nitric acid, and heat to the
Solution A: 300 mg/mL of sodium tartrate in water evolution of sulfur trioxide. Allow to cool, add about 25 mL
Solution B: 200 mg/mL of titanium trichloride in water of water, and boil for a few min. Cool, neutralize with
Solution C: Prepare 500 mL of a mixture of water, Solution stronger ammonia water, using litmus paper as the
B, and hydrochloric acid (400:40:40) to which about 10 mg indicator, and add 5 mL of nitric acid. Transfer the solution
of safranin O has been added. to a 100-mL volumetric flask, and dilute to volume.
Sample: 100 mg Analysis: Proceed as directed, using a 20-mL portion of the
Titrimetric system Sample solution.
Mode: Direct titration Acceptance criteria: NMT 30 ppm of lead▲ (USP 1-Aug-2022)
Titrant: 0.05 N titanium trichloride VS
Endpoint detection: Visual SPECIFIC TESTS
Analysis: Dissolve the Sample in 175 mL of water in a • LOSS ON DRYING á731ñ
500-mL closed system titration vessel fitted with a gas inlet Analysis: Dry at 105° to constant weight.
tube, a gas outlet tube, an upright reflux condenser, and a Acceptance criteria: NMT 5.0%
buret. Add about 25 mL of Solution A and a polytef-coated ADDITIONAL REQUIREMENTS
magnetic stirring bar, and heat to boiling. Flush this • PACKAGING AND STORAGE: Preserve in well-closed
titration vessel for 15 min with nitrogen that has been containers.
passed through two successive gas washing bottles, each
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