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Orlistat 96829-58-2 Orlistat 96829-58-2

Orlistat 96829-58-2
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Basic information of Orlistat 96829-58-2

Name

Orlistat

CAS

96829-58-2

EINECS


Molecular Formula

C29H53NO5

Molecular Weight

495.73

Quality Standard

USP37/ in-house standarad, 98.5%

Package Size

5kg/tin

Brief Introduction

White to off-white crystalline powder,insoluble in water,soluble in chloroform and ethanol, it is the good drug for the weight losing.


Usage of Orlistat 96829-58-2

  • This is the good API for weight losing.

COA of Orlistat 96829-58-2

TestItems

Specification

Results

Appearance

White to off-white fine powder or fine powder with lumps

Conforms

Specification Rotation

-48°-- -51°(on the anhydrous, solvent-free basis)

-50.3°

Identification

A: HPLC  the retention time of the major peak of the sample solution corresponds to that of the standardsolution.

B: IR  The IR spectrum of sample is consistent to the reference solution



conforms

Related substance



Total impurity

NMT 1.0%

0.21%

Related compound A

NMT 0.2%

Conforms

Related compound B

NMT 0.05%

ND

Related compound C

NMT0.05%

0.006%

Related compound D

NMT 0.2%

N.D

Related compound E

NMT 0.2%

0.02%

Formylleucine

NMT 0.2%

N.D

Orlistat open ring epimer

NMT 0.2%

N.D

D-Leucine orlistat

NMT 0.2%

N.D

Orlistat open ring Amide

NMT0.1%

N.D

Individual Unidentified impurity

NMT 0.1%

0.04%

Residual Solvents



n-Heptane

NMT 5000PPM

742PPM

Isopropyl Ether

NMT 5000PPM

N.D

Methanol

NMT3000PPM

N.D

Tetrahydrofuran

NMT 720PPM

N.D

Residual on ignition

NMT0.1%

0.06%

Heavy metal

NMT 20PPM

conforms

Assay

98.0%-101.5% (on the anhydrous, solvent-free basis)

99.3%

Water

NMT 0.2%

0.09

conclusion

It conforms to USP37


MORE_DETAIL Orlistat 96829-58-2

Basic information of Orlistat 96829-58-2

Name

Orlistat

CAS

96829-58-2

EINECS


Molecular Formula

C29H53NO5

Molecular Weight

495.73

Quality Standard

USP37/ in-house standarad, 98.5%

Package Size

5kg/tin

Brief Introduction

White to off-white crystalline powder,insoluble in water,soluble in chloroform and ethanol, it is the good drug for the weight losing.


Usage of Orlistat 96829-58-2

  • This is the good API for weight losing.

COA of Orlistat 96829-58-2

TestItems

Specification

Results

Appearance

White to off-white fine powder or fine powder with lumps

Conforms

Specification Rotation

-48°-- -51°(on the anhydrous, solvent-free basis)

-50.3°

Identification

A: HPLC  the retention time of the major peak of the sample solution corresponds to that of the standardsolution.

B: IR  The IR spectrum of sample is consistent to the reference solution



conforms

Related substance



Total impurity

NMT 1.0%

0.21%

Related compound A

NMT 0.2%

Conforms

Related compound B

NMT 0.05%

ND

Related compound C

NMT0.05%

0.006%

Related compound D

NMT 0.2%

N.D

Related compound E

NMT 0.2%

0.02%

Formylleucine

NMT 0.2%

N.D

Orlistat open ring epimer

NMT 0.2%

N.D

D-Leucine orlistat

NMT 0.2%

N.D

Orlistat open ring Amide

NMT0.1%

N.D

Individual Unidentified impurity

NMT 0.1%

0.04%

Residual Solvents



n-Heptane

NMT 5000PPM

742PPM

Isopropyl Ether

NMT 5000PPM

N.D

Methanol

NMT3000PPM

N.D

Tetrahydrofuran

NMT 720PPM

N.D

Residual on ignition

NMT0.1%

0.06%

Heavy metal

NMT 20PPM

conforms

Assay

98.0%-101.5% (on the anhydrous, solvent-free basis)

99.3%

Water

NMT 0.2%

0.09

conclusion

It conforms to USP37

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