Product Description
Fenofibrate Micronized Capsules CP Antilipemic 200mg
Product Name: Fenofibrate Micronized Capsules
Indication: Antilipemic
Dosage Form: Capsule
Validity: 2 years
Strength: 200mg
Place of Origin: China (Mainland)
Min.Order Quantity: 10,000boxes
Package Details: 15tablets/box, 200 Boxes/carton
Quality Specification: CP USP
DEFINITION
Fenofibrate Capsules contain NLT 90.0% and NMT 110.0% of the labeled amount of fenofibrate (C20H21ClO4).
IDENTIFICATION
• A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Use Sample stock solution 2 for Capsules labeled to meet the requirements of Dissolution Test 2. For all other products, use Sample stock solution 1.
Solution A: 136 mg/L of monobasic potassium phosphate in water. Adjust with dilute phosphoric acid (1 in 10) to a pH of 2.9 ± 0.05.
Mobile phase: Methanol and Solution A (4:1)
Standard solution: 67 µg/mL of USP Fenofibrate RS in Mobile phase
Sample stock solution 1: Accurately weigh the contents of NLT 20 Capsules. Mix the contents, and transfer a weighed portion of the powder, equivalent to about 67 mg of fenofibrate, to a 100-mL volumetric flask. Add 80 mL of Mobile phase, sonicate for 10 min, stir for 15 min, and dilute with Mobile phase to volume.
Sample stock solution 2 (for Capsules labeled to meet the requirements of Dissolution Test 2): Weigh the contents of NLT 20 Capsules. Mix the contents, melt in an oven at 80 for NLT 30 min, and homogenize. Allow the sample to solidify. Transfer a weighed portion of the sample, equivalent to about 67 mg of fenofibrate, to a 100-mL volumetric flask, dissolve in 30 mL of methanol with the aid of a mechanical shaker for NLT 4 h, and dilute with Mobile phase to volume.
Sample solution: Nominally 67 µg/mL of fenofibrate from the designated Sample stock solution, in Mobile phase. Pass a portion of this solution through a polyvinylidene difluoride (PVDF) filter of 0.45-µm pore size, discarding the first 5 mL.
Chromatographic system
(See Chromatography 621, System Suitability.)
Mode: LC
Detector: UV 285 nm
Column: 4.6-mm × 15-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection volume: 20 µL
System suitability
Sample: Standard solution
Suitability requirements
Column efficiency: NLT 6000 theoretical plates
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of fenofibrate (C20H21ClO4) in the portion of Capsules taken:
Result = (rU/rS) × (CS/CU) × 100
rU = = peak response from the Sample solution
rS = = peak response from the Standard solution
CS = = concentration of the Standard solution (µg/mL)
CU = = nominal concentration of the Sample solution (µg/mL)
Acceptance criteria: 90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
Test 1
Medium: 0.05 M sodium lauryl sulfate in water; 1000 mL, deaerated
Apparatus 2: 75 rpm
Time: 40 min
Solution A and Mobile phase: Proceed as directed in the Assay.
Standard solution: (0.001 × L) mg/mL of USP Fenofibrate RS in Mobile phase, where L is the label claim, in mg/Capsule
Sample solution: Pass a portion of the solution under test through a suitable PVDF filter of 0.45-µm pore size.
Chromatographic system
(See Chromatography 621, System Suitability.)
Mode: LC
Detector: UV 285 nm
Column: 4.6-mm × 15-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection volume: 10 µL for Capsules labeled to contain 67 mg; 5 µL for Capsules labeled to contain 134 or 200 mg
System suitability
Sample: Standard solution
Suitability requirements
Column efficiency: NLT 4000 theoretical plates
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of fenofibrate (C20H21ClO4) dissolved:
Result = (rU/rS) × (CS/L) × V × 100
rU = = peak response from the Sample solution
rS = = peak response from the Standard solution
CS = = concentration of the Standard solution (mg/mL)
L = = label claim (mg/Capsule)
V = = volume of Medium, 1000 mL
Tolerances: NLT 70% (Q) of the labeled amount of fenofibrate (C20H21ClO4) is dissolved.
Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.
Medium: Phosphate buffer pH 6.8 ± 0.1 containing 0.1% pancreatin and 2% polysorbate 80; 900 mL, deaerated by vacuum
Apparatus 2: 75 rpm with sinkers (see Dissolution 711, Figure 2a)
Time: 2 h
Standard solution: (L/1000) mg/mL of USP Fenofibrate RS in Medium, where L is the Capsule label claim, in mg. A volume of methanol, not exceeding 10%, can be used in the first dilution to solubilize fenofibrate.
Sample solution: Pass 20 mL of the solution under test through a suitable PVDF filter of 0.45-µm pore size, discarding the first 2 mL.
Blank: Medium
Instrumental conditions
(See Spectrophotometry and Light-Scattering 851.)
Mode: Spectrophotometry
Detector: UV 288 nm
Path length: 0.1-cm flow cell
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of fenofibrate (C20H21ClO4) dissolved:
Result = (AU/AS) × (CS/L) × V × 100
