Pyridoxine Hydrochloride
(pir'' i dox' een hye'' droe klor' ide).
C8H11NO3·HCl 205.64 3,4-Pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride; Pyridoxol hydrochloride [58-56-0]. DEFINITION
Pyridoxine Hydrochloride contains NLT 98.0% and NMT 102.0% of pyridoxine hydrochloride (C8H11NO3·HCl), calculated on the dried basis.
IDENTIFICATION
• B. Identification TestsGeneral, Chloride 191:
Meets the requirements
ASSAY
• Procedure
Mobile phase:
Mix 10 mL of glacial acetic acid, 0.6 g of sodium 1-hexanesulfonate, and 700 mL of water in a 1000-mL volumetric flask. Adjust with glacial acetic acid or 1 N sodium hydroxide to a pH of 3.0. Add 235 mL of methanol, and dilute with water to volume.
Internal standard solution:
5 mg/mL of p-hydroxybenzoic acid in Mobile phase
Standard solution:
Prepare a 0.5-mg/mL solution of USP Pyridoxine Hydrochloride RS in Mobile phase. Transfer 10.0 mL of this solution and 1.0 mL of Internal standard solution to a 100-mL volumetric flask, and dilute with Mobile phase to volume.
Sample solution:
Prepare a 0.5-mg/mL solution of Pyridoxine Hydrochloride in Mobile phase. Transfer 10.0 mL of this solution and 1.0 mL of Internal standard solution to a 100-mL volumetric flask, and dilute with Mobile phase to volume.
Chromatographic system
Mode:
LC
Detector:
UV 280 nm
Column:
4.6-mm × 25-cm; packing L1
Flow rate:
1.5 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
[NoteThe relative retention times for pyridoxine and p-hydroxybenzoic acid are about 0.7 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 2.5 between pyridoxine and p-hydroxybenzoic acid
Relative standard deviation:
NMT 3.0% for the ratios of the pyridoxine peak area response to the internal standard peak area response
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of pyridoxine hydrochloride (C8H11NO3·HCl) in the portion of Pyridoxine Hydrochloride taken:
Result = (RU/RS) × (CS/CU) × 100
Acceptance criteria:
98.0%102.0% on the dried basis
IMPURITIES
• Residue on Ignition 281:
NMT 0.1%
• Heavy Metals, Method II 231:
NMT 30 ppm
SPECIFIC TESTS
• Content of Chloride
Sample:
500 mg of Pyridoxine Hydrochloride
Blank:
50 mL of methanol
Titrimetric system
(See Titrimetry 541.)
Mode:
Direct titration
Titrant:
0.1 N silver nitrate VS
Endpoint detection:
Visual
Analysis:
Dissolve the Sample in 50 mL of methanol. Add 5 mL of glacial acetic acid and 23 drops of eosin Y TS. Titrate with the Titrant. Perform a Blank determination.
Calculate the percentage of chloride (Cl) in the Sample taken:
Result = {[(VS VB) × N × F]/W} × 100
Acceptance criteria:
16.9%17.6% on the dried basis
• Loss on Drying 731:
Dry a sample in vacuum over silica gel for 4 h: it loses NMT 0.5% of its weight.
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 4491
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