Thiamine Hydrochloride Tablets
DEFINITION
Thiamine Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of thiamine hydrochloride (C12H17ClN4OS·HCl).
IDENTIFICATION
• A.
Sample solution:
Triturate a quantity of powdered Tablets, equivalent to 10 mg of thiamine hydrochloride, with 10 mL of 0.5 N sodium hydroxide, and filter.
Analysis:
To 5 mL of the Sample solution add 0.5 mL of potassium ferricyanide TS and 5 mL of isobutyl alcohol, shake the mixture vigorously for 2 min, and allow the liquid layers to separate. Illuminate from above by a vertical beam of UV light, and observe the airliquid meniscus at a right angle to this beam.
Acceptance criteria:
The airliquid meniscus shows a vivid blue fluorescence, which disappears when the mixture is slightly acidified, but reappears when it is again made alkaline.
• B.
Sample solution:
Triturate a quantity of powdered Tablets, equivalent to 10 mg of thiamine hydrochloride, with 10 mL of water, and filter.
Analysis 1:
To 2 mL of the Sample solution add iodine TS.
Acceptance criteria 1:
A red-brown precipitate is formed.
Analysis 2:
To 2 mL of the Sample solution add mercuric chloride TS.
Acceptance criteria 2:
A white precipitate is formed.
Analysis 3:
Identification TestsGeneral 191, Chloride
Acceptance criteria 3:
Meet the requirements
• C.
Sample solution:
Use the remainder of the Sample solution from Identification test B.
Analysis:
Add 1 mL of lead acetate TS and 1 mL of 2.5 N sodium hydroxide.
Acceptance criteria:
A yellow color is produced. Heat the mixture for several min on a steam bath: the color changes to brown, and, on standing, a precipitate of lead sulfide separates.
ASSAY
• Thiamine Assay 531
Assay preparation:
Place NLT 20 Tablets in a flask of suitable size, half fill the flask with 0.2 N hydrochloric acid, and heat on a steam bath, with frequent agitation, until the Tablets have dissolved or have disintegrated so that a uniform dispersion is obtained. Cool, transfer the contents of the flask to a volumetric flask, and dilute with 0.2 N hydrochloric acid to volume. If the mixture is not clear, either centrifuge it or filter it through paper known not to adsorb thiamine. Dilute a portion of the clear solution with 0.2 N hydrochloric acid to obtain a 0.2 µg/mL solution of thiamine hydrochloride.
Analysis:
Proceed as directed in the chapter.
Acceptance criteria:
90.0%110.0%
PERFORMANCE TESTS
• Dissolution, Procedure for a Pooled Sample 711
Medium:
Water; 900 mL
Apparatus 2:
50 rpm
Time:
45 min
Standard solution:
A known concentration of USP Thiamine Hydrochloride RS in Medium
Sample solution:
Filtered portion of the solution under test, suitably diluted with the Medium if necessary
Mobile phase:
A mixture of methanol, glacial acetic acid, and water (27:1:73) containing 1.40 mg/mL of sodium 1-hexanesulfonate
Chromatographic system
Mode:
LC
Detector:
UV 280 nm
Column:
3.9-mm × 30-cm; packing L1
Flow rate:
1 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 3.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of thiamine hydrochloride (C12H17ClN4OS·HCl) dissolved:
Result = (rU/rS) × (CS × D × V/L) × 100
Tolerances:
NLT 75% (Q) of the labeled amount of thiamine hydrochloride (C12H17ClN4OS·HCl) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4837
Pharmacopeial Forum: Volume No. 30(1) Page 190
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