99% Assay High Purity Solifenacin Succinate Pharmaceutical Chemical Powder with CAS 242478-38-2

China 99% Assay High Purity Solifenacin Succinate Pharmaceutical Chemical Powder with CAS 242478-38-2, Find details about China Solifenacin Succinate, Chemicals Solifenacin Succinate from 99% Assay High Purity Solifenacin Succinate Pharmaceutical Chemical Powder with CAS 242478-38-2

Model NO.
242478-38-2
Trademark
MESOCHEM
Transport Package
25kg
Specification
GMP
Origin
China
HS Code
2934999090
Model NO.
242478-38-2
Trademark
MESOCHEM
Transport Package
25kg
Specification
GMP
Origin
China
HS Code
2934999090
Certificate  of  Analysis
Product Name: Solifenacin Succinate
CAS No.: 242478-38-2
 
Batch No.HF161203Quantity15.6kgs
Mfg. DateDec. 03, 2016PackageAs required
Rep. DateDec. 06, 2016Exp. DateDec. 02, 2018
ItemsStandardsResults
AppearanceWhite or off-white crystalline powderComplies
IdentificationBy IRComplies
By HPLCComplies
SolubilityFreely soluble in acetic acid, water, methanol, dimethylsulfoxideComplies
Melting Point144ºC~150ºC146.0ºC~147.5ºC
Specific Optical Rotation+88.0º~+94.0º+90.2
Loss on Drying0.50%0.06%
Heavy Metals20ppmComplies
Residue on Ignition≤0.10%0.03%
3-Quinuclidinol0.20%Complies
Succinate Content23.5%~25.5%24.7%
Optical IsomerDiastereoisomer RS: 0.15%ND
Diastereoisomer SS: 0.15%ND
Diastereoisomer RR: 0.20%ND
Residual SolventAcetone: 5000ppmND
Dichloromethane: 600ppmND
Toulene: 890ppmND
Di isopropyl ether: 500ppmND
Dimethyl formamide: 880ppmND
Related SubstancesAny single impurity: 0.10%0.02%
Total impurities: 0.50%0.05%
Assay
(HPLC basis on drying)
98.0%~102.0%99.92%
Reference StandardIn-house Standard
ConclusionThe product complied to In-house standard.
StoragePreserve in tight,light-resistant containers in a cool place
  Tested By:Wang Chao                         Checked By:  Li Yan

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