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1, 4-Androstadien-3, 17-Dione-6-Methylene-D2 Aromatase Exeme Stane CAS 107868 -30-4

China 1, 4-Androstadien-3, 17-Dione-6-Methylene-D2 Aromatase Exeme Stane CAS 107868-30-4, Find details about China 107868-30-4, Exeme Stane from 1, 4-Androstadien-3, 17-Dione-6-Methylene-D2 Aromatase Exeme Stane CAS 107868-30-4

Model NO.
SAMREAL-0367
Standard
USP
Trademark
samreal
Specification
1kg/bag
Origin
China
HS Code
2937239090
Model NO.
SAMREAL-0367
Standard
USP
Trademark
samreal
Specification
1kg/bag
Origin
China
HS Code
2937239090
Exeme stane cas 107868-30-4
ItemsStandardResults
Appearance White or almost white crystalline powderWhite crystalline powder 
Particle sizeD(0.1)≤5μm1μm
D(0.5)≤8μm4μm
D(0.9)≤15μm8μm
Melting point192ºC~196ºC193ºC~195ºC
Identification HPLC:The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the assay.Complies 
IR:The infrared absorption spectrum of the sample should correspond to the spectrum of the reference substanceComplies 
X-ray diffraction:Exeme stane should conform to primary reference standard(Form A):Exeme stane should be characterized by a powder x-ray diffraction pattern having peaks at 10.7±0.2°,15.9±0.2°.and 18.1±0.2° 2-theta degreeComplies 
Specific optical rotation(on arhydrous basis)+290°~+300°+292°
Water determination ≤0.3%0.1%
Residue on ignition≤0.10.05%
Assay (anhydrous substance)98.0%~102.0%101.2%
Organic impuritiesSpirooxiran 1
(6α-Spirooxiran-androsta-1,4-diene-3,17-dione)≤0.15%		0.003%
Spirooxiran 2
(6β-Spirooxiran-androsta-1,4-diene-3,17-dione)≤0.15%		0.01%
Exeme stane related compound C
C(Androsta-1,4-diene-3,17-dione)≤0.15%		0.002%
E'xemestane related compound A
A(6-Methyleneandrosta-4-ene-3,17-dione)≤0.15%		N.D.
Androsta-4-ene-3,17-dione≤0.15%N.D.
Exeme stane related compound D≤0.1%N.D.
Single unspecified impurity*≤0.1%0.01%
Total impurities≤0.5%0.03%
Residual solventsPetroleum ether≤50ppmN.D.
Acetone ≤5000ppm28ppm
Tetrahydrofuran ≤720ppmN.D.
Dichloromethane ≤600ppmN.D.
Ethanol ≤5000ppmN.D.
Toluene ≤890ppmN.D.
1,4-Dioxane≤380ppmN.D.
Benzene ≤2ppmN.D.
Microbial limitsTotal aerobic microbial count≤100cfu/g<40cfu/g
Total molds and yeasts count≤50cfu/g<10cfu/g
Escherichia coli:Absent(1g)Absent
Underlined items at least the first three batches every production cycle,if this production cycle produce more than 10 batches,at least every tenth batch.
Note:*item show that Exeme stane related compound B have been controlled as single unspecified impurity.
ConclusionConforms to Authorized USP pending Standards,USP42.
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1, 4-Androstadien-3, 17-Dione-6-Methylene-D2 Aromatase Exeme Stane CAS 107868-30-41, 4-Androstadien-3, 17-Dione-6-Methylene-D2 Aromatase Exeme Stane CAS 107868-30-41, 4-Androstadien-3, 17-Dione-6-Methylene-D2 Aromatase Exeme Stane CAS 107868-30-41, 4-Androstadien-3, 17-Dione-6-Methylene-D2 Aromatase Exeme Stane CAS 107868-30-41, 4-Androstadien-3, 17-Dione-6-Methylene-D2 Aromatase Exeme Stane CAS 107868-30-4

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