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D-Cloprostenol Sodium CAS 62561-03-9 Cloprostenol sodium 

Payment Terms: T/T,L/C,WU 
Place of Origin: Sichuan, China (Mainland) 
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Product Detail

Means of Transport: Ocean,Land,Air
Packing: According to the request of...
Brand: MOSINTER
Appearance: White to off-white amorphou...
Molecular weight: 446.9
Lot No: PG16S-20131101
Production Capacity: 100kg/Year
Delivery Date: within 7 days
Molecular formula: C22H28ClNaO6
CAS: 62561-03-9
Name: D-Cloprostenol Sodium
Alias: (+)-Cloprostenol sodium

CU is the concentration, in mg per mL, of Cloprostenol Sodium in the Assay

D-Cloprostenol Sodium (CAS: 62561-03-9)


ITEM

SPECIFICATION

INDEX

Appearance

White to off-white amorphous powder,
hygroscopic

White amorphous
powder, hygroscopic

Water,%

≤3.0

1.9

Specific Rotation[a] 20D (C=1,Ethanol)

Between +25° to +30°

+27.6°

Residual solvents,%

Methanol

Ethanol

N-Hexane

Toluene

Tert-Butyl-methyl ether

≤0.3

≤0.5

≤0.029

≤0.089

≤0.5

Conform

15-Epimer, %

≤1.0

0.08

5,6-Trans isomer, %

≤2.0

0.04

(-)-enantiomer

≤2.0

Not detected

Other maximum single impurity, %

≤0.5

0.02

Assay, %

≥98.5

99.6

Cloprostenol Sodium(kloe prost' e nol soe' dee um).C22H28ClNaO6 446.905-Heptenoic acid, 7-[2-[4-(3-chlorophenoxy)-3-hydroxy-1-butenyl]-3,5-dihydroxycyclopentyl]-, [1 (Z),2 (1 E,3R*),3 ,5 ]-, sodium salt, (± )-.(± )-Sodium (Z)-7-[(1 R*,2R*,3R*,5S*)-2-[(E)-(3R*)-4-(m-chlorophenoxy)-3-hydroxy-1-butenyl]-3,5-dihydroxycyclopentyl]-5-heptenoate [55028-72-3].

» Cloprostenol Sodium contains not less than 97.5 percent and not more than
102.5 percent of C22H28ClNaO6, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— Label it to indicate that it is for veterinary use only.
USP REFERENCE STANDARDS 11 —USP Cloprostenol Sodium RS
Identification—
A: INFRARED ABSORPTION 197K  .
B: It meets the requirements of the test for Sodium 191 .
WATER, Method I 921 — Use 50 mg dissolved in 1 mL of dehydrated alcohol: not morethan 3.0%.
Chromatographic purity—
Mobile phase— Prepare a filtered and degassed mixture of the chromatographic solventhexane, dehydrated alcohol, and glacial acetic acid (930:70:1). Make adjustments ifnecessary (see System Suitability under Chromatography 621 )


Test solution— Dissolve an accurately weighed quantity of Cloprostenol Sodium indehydrated alcohol, and dilute quantitatively, and stepwise if necessary, with dehydratedalcohol to obtain a solution having a known concentration of about 20 mg per mL.
Chromatographic system (see CHROMATOGRAPHY 621 )— Prepare as directed in the
Assay.
Procedure— Inject a volume (about 5 µL) of the Test solution into the chromatograph.Record the chromatogram for a total time of not less than twice the retention time of thepeak due to cloprostenol, and measure all of the peak responses. Calculate thepercentage of each impurity in the portion of Cloprostenol Sodium taken by the formula:100(ri / rs)in which r
i is the peak response for each impurity, and rs is the sum of the responses of allof the peaks: not more than 1.0% of any individual impurity is found; and not more than2.5% of total impurities is found. Disregard any peak below 0.05%.
Assay—
Mobile phase— Prepare a filtered and degassed mixture of the chromatographic solventhexane, dehydrated alcohol, and glacial acetic acid (900:100:1). Make adjustments ifnecessary (see System Suitability under Chromatography 621 ).
Standard preparation— Dissolve an accurately weighed quantity of USP Cloprostenol
Sodium RS in dehydrated alcohol, and dilute quantitatively, and stepwise if necessary,with dehydrated alcohol to obtain a solution having a known concentration of about 0.8mg per mL.
Assay preparation— Using a suitable quantity of Cloprostenol Sodium, accuratelyweighed, proceed as directed in the Standard preparation.
Chromatographic system (see CHROMATOGRAPHY 621 )— The liquid chromatograph isequipped with a 220-nm detector and a 4.6-mm ×  25-cm column that contains 5-µmpacking L3. The flow rate is about 1.8 mL per minute. Chromatograph the Standard
preparation, and record the peak responses as directed for Procedure: the tailing factor isnot more than 1.5 for the cloprostenol peak; and the relative standard deviation forreplicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 5 µL) of the Standard preparationand the Assay preparation into the chromatograph, record the chromatograms, andmeasure the responses for the major peaks. Calculate the percentage of C22H28ClNaO6in the portion of Cloprostenol Sodium taken by the formula:100(CS / CU)(rU / rS)in which C
S is the concentration, in mg per mL, of USP Cloprostenol RS in the Standard

preparation; CU is the concentration, in mg per mL, of Cloprostenol Sodium in the Assay
preparation; and rU and rS are the cloprostenol peak responses obtained from the Assay
preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contactingUSP.

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