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200mg Fenofibrate Micronized Capsules CP Antilipemic Lipid Lowering Drugs

Brand Name:	LIBANG
MOQ:	10,000 boxes
Payment Terms:	T/T, L/C

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

Chinese GMP

Quality Specification:

Strength:

200mg

Packaging Details:

15 tablets/box, 200 Boxes/carton

Highlight:

200mg Fenofibrate Micronized Capsule

Fenofibrate Micronized Capsules CP Antilipemic

Fenofibrate Micronized Lipid Lowering Drugs

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

Tags:

Diatrizoic Acid

Fulvestrant

Meglumine

Melphalan

Nicorandil

Propofol

Tranexamic Acid

Tolperisone Hydrochloride

Lecithin

Lipid Emulsion

Succinylcholine Chloride

Other and Cardiovascular Series

others

Diatrizoic Acid

Fulvestrant

Meglumine

Melphalan

Nicorandil

Propofol

Tranexamic Acid

Tolperisone Hydrochloride

Lecithin

Lipid Emulsion

Succinylcholine Chloride

Other and Cardiovascular Series

others

products details

200mg Fenofibrate Micronized Capsules CP Antilipemic Lipid Lowering Drugs

200mg Fenofibrate Micronized Capsules CP Antilipemic Lipid Lowering Drugs

200mg Fenofibrate Micronized Capsule

Fenofibrate Micronized Capsules CP Antilipemic

Fenofibrate Micronized Lipid Lowering Drugs