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Fenofibrate 49562-28-9 Fenofibrate 49562-28-9

Fenofibrate 49562-28-9
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Maklumat asas Fenofibrate

Name

Fenofibrate

Alias

 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid isopropyl ester; proctofene; sedufen

CAS NO.

49562-28-9

Molecular Formula

C20H21ClO4

Molecular Weight

360.84

Quality Standard

98% min;USP/EP/BP

Grade Standard

Medicine grade

Package Size

25kg/drum

Penggunaan Fenofibrate

Fenofibrate terutamanya digunakan untuk menurunkan tahap kolesterol pada pesakit yang berisiko untuk penyakit kardiovaskular. Fenofibrate boleh menurunkan lipoprotein berkepadatan rendah (LDL) dan paras lipoprotein ketumpatan rendah (VLDL), dan meningkatkan paras lipoprotein ketumpatan tinggi (HDL) dan paras trigliserida (TG) yang lebih rendah. Fenofibrate boleh digunakan secara bersendirian atau digabungkan dengan statin untuk merawat hiperkolesterolemia dan hypertriglyceridemia.

COA of Fenofibrate

ITEM

STANDARD

RESULT

Characteristics

White or almost white crystalline powder

almost white crystalline powder


Solubility

Practically insoluble in water, very soluble in methylene chloride, slightly soluble in alcohol

Conforms

Identification

A: Melting range

           79℃-82℃

80℃-81℃

B: IR

         Meets the requirements

Conforms

Appearance of solution

Clear and not more intensely colored than reference solution BY6

Conforms

Acidity

Meets the requirements

Conforms

Particle size

90%<20µm,50%<10µm

Conforms

Related substance

Impurity A

            ≤0.1%

0.0007%

Impurity B

            ≤0.1%

0.001%

Impurity G

            ≤0.2%

0.004%

Single Impurity

            ≤0.1%

0.02%

Sum of all impurity

            ≤0.5%

0.03%

Halides expressed as chlorides

≤100ppm

﹤100ppm

Sulphates

≤100ppm

﹤100ppm

Heavy metals

≤20ppm

﹤20ppm

Loss on drying

≤0. 5%

0.06%

Sulphated ash

≤0.1%

0.05%

Assay

98.5%-101.0%

99.5%

Conclusion:                  Up to the standard ofEP6.0


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MORE_DETAIL Fenofibrate 49562-28-9

Maklumat asas Fenofibrate

Name

Fenofibrate

Alias

 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid isopropyl ester; proctofene; sedufen

CAS NO.

49562-28-9

Molecular Formula

C20H21ClO4

Molecular Weight

360.84

Quality Standard

98% min;USP/EP/BP

Grade Standard

Medicine grade

Package Size

25kg/drum

Penggunaan Fenofibrate

Fenofibrate terutamanya digunakan untuk menurunkan tahap kolesterol pada pesakit yang berisiko untuk penyakit kardiovaskular. Fenofibrate boleh menurunkan lipoprotein berkepadatan rendah (LDL) dan paras lipoprotein ketumpatan rendah (VLDL), dan meningkatkan paras lipoprotein ketumpatan tinggi (HDL) dan paras trigliserida (TG) yang lebih rendah. Fenofibrate boleh digunakan secara bersendirian atau digabungkan dengan statin untuk merawat hiperkolesterolemia dan hypertriglyceridemia.

COA of Fenofibrate

ITEM

STANDARD

RESULT

Characteristics

White or almost white crystalline powder

almost white crystalline powder


Solubility

Practically insoluble in water, very soluble in methylene chloride, slightly soluble in alcohol

Conforms

Identification

A: Melting range

           79℃-82℃

80℃-81℃

B: IR

         Meets the requirements

Conforms

Appearance of solution

Clear and not more intensely colored than reference solution BY6

Conforms

Acidity

Meets the requirements

Conforms

Particle size

90%<20µm,50%<10µm

Conforms

Related substance

Impurity A

            ≤0.1%

0.0007%

Impurity B

            ≤0.1%

0.001%

Impurity G

            ≤0.2%

0.004%

Single Impurity

            ≤0.1%

0.02%

Sum of all impurity

            ≤0.5%

0.03%

Halides expressed as chlorides

≤100ppm

﹤100ppm

Sulphates

≤100ppm

﹤100ppm

Heavy metals

≤20ppm

﹤20ppm

Loss on drying

≤0. 5%

0.06%

Sulphated ash

≤0.1%

0.05%

Assay

98.5%-101.0%

99.5%

Conclusion:                  Up to the standard ofEP6.0

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