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

Fenofibrate 49562-28-9
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Informasi dasar 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 terutama digunakan untuk menurunkan kadar kolesterol pada pasien yang berisiko terkena penyakit kardiovaskular. Fenofibrate dapat menurunkan low-density lipoprotein (LDL) dan sangat low-density lipoprotein (VLDL), dan meningkatkan tingkat high density lipoprotein (HDL) dan menurunkan trigliserida (TG). Fenofibrate dapat digunakan sendiri atau dalam kombinasi dengan statin untuk mengobati hiperkolesterolemia dan hipertrigliseridemia.

COA 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

Informasi dasar 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 terutama digunakan untuk menurunkan kadar kolesterol pada pasien yang berisiko terkena penyakit kardiovaskular. Fenofibrate dapat menurunkan low-density lipoprotein (LDL) dan sangat low-density lipoprotein (VLDL), dan meningkatkan tingkat high density lipoprotein (HDL) dan menurunkan trigliserida (TG). Fenofibrate dapat digunakan sendiri atau dalam kombinasi dengan statin untuk mengobati hiperkolesterolemia dan hipertrigliseridemia.

COA 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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