Xinchang Yueding Chemical Co., Ltd. >> Pharmaceutical Oxytocin Acetate (GMP standard product)

Pharmaceutical Oxytocin Acetate (GMP standard product)

Pharmaceutical Oxytocin Acetate (GMP standard product)
Price: US $ 70-70g
Trade Terms: FOB,CFR,CIF
Min Order: 1g
Pay Type: L/C,T/T

Product Specifications

Prod Model: CAS No. 50-56-6
Markets: North America,South America,Eastern Europe,Southeast Asia,Africa,Oceania,Mid East,Eastern Asia,Western Europe
Is A Manufacturer GMP Standard: Manufacturer, Factory . GMP
Appearance: Powder
Classification: Hormone
Function: a) for Stimulation of Uterus Contractions to Facil

Product Description

CAS: 50-56-6
Purity (by HPLC): More than 98.50%
Single impurity: Less than 0.50%


Appearance(EP. Curr. ED): White or almost white, hygroscopic powder
Solubility(EP. Curr. ED): Very soluble in water,
It dissolves in dilute
Solutions of acetic acid and ethanol(1: 20).
HPLC(EP. Curr. ED): The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution.

Amino acid analysis
(EP. Curr. ED)Amino acid limits
Asp (0.90-1.10)
Glu (0.90-1.10)
PRO (0.90-1.10)
Gly (0.90-1.10)
Leu (0.90-1.10)
Ile (0.90-1.10)
Tyr (0.7-1.05)
Half-Cys (1.40-2.10)
No more than the traces
Of the other amino acids are present.

pH(EP. Curr. ED): 3.0-6.0 (200mg OT in 10ml Of CO2 free water)

Related Substances(EP. Curr. ED):
Specified impurities
Impurity A: NMT 1.0%
Impurity B: NMT 1.5%
Impurity C: NMT1.0%
Any unspecified impurity: NMT 5%
Total impurity: NMT 5%

Acetic acid(EP. Curr. ED): 6%-10%

Water(EP. Curr. ED): NMT 5%

Bacterial Endotoxins(EP. Curr. ED): Less than 300IU/mg

Assay(EP. Curr. ED): 93%-102%

Biological activity: Not less than 480IU/mg

Specific Optical Rotation: -19.5 to -23.5

Residual solvent
Methanol: NMT 3000ppm
Acetonitrile: NMT 410ppm
Triethylamine: NMT 320ppm
CERTIFICATION OF ANALYSIS
OXYTOCIN
EP Powder(Synthetic)
Cas No.: 50-56-6
   
   
       
Test Specification Result Test method
Reference No.
Appearance
(EP.curr.ed)
White or almost white , hygroscopic powder White hygroscopic powder PT/QC/OT/01-1
Solubility
(EP.curr.ed)
Very soluble in water,
it dissolves in dilute
solutions of acetic acid and ethanol(1:20).
Very soluble in water, it dissolves in dilute solutions of acetic acid and ethanol (1:20). PT/QC/OT/01-2
HPLC
(EP.curr.ed)
The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution. Complies PT/QC/OT/01-3
Amino acid analysis
(EP.curr.ed)
Amino acid    limits
Asp          (0.90-1.10)
Glu          (0.90-1.10)
Pro          (0.90-1.10)
Gly          (0.90-1.10)
Leu          (0.90-1.10)
Ile           (0.90-1.10)
Tyr           (0.7-1.05)
Half-Cys      (1.40-2.10)
No more than the traces
of the other amino acids are present.
1.01
0.99
1.00
1.01
1.02
0.97
0.96
1.50
Complies
 
PT/QC/OT/01-4
pH
(EP.curr.ed)
3.0-6.0 (200mg OT in 10ml
Of CO2 free water)
4.35 PT/QC/OT/01-5
 
 
 
 
 
OXYTOCIN 
EP Powder(Synthetic)
Cas No.: 50-56-6
   
   
 
Test Specification Result Test method
Reference No.
Related Substances
(EP.curr.ed)
Specified impurities
Impurity A : NMT 1.0%
Impurity B : NMT 1.5%
Impurity C : NMT1.0%
Any unspecified impurity: NMT 5%
Total impurity: NMT 5%
 
0.20%
0.25%

 
0.45%
PT/QC/OT/01-6
Acetic acid
(EP.curr.ed)
6%-10% 7.2% PT/QC/OT/01-7
water
(EP.curr.ed)
NMT 5% 4.5% PT/QC/OT/01-8
Bacterial Endotoxins
(EP.curr.ed)
Less than 300IU/mg complies PT/QC/OT/01-9
Assay
(EP.curr.ed)
93%-102% 95.60% PT/QC/OT/01-10
Biological activity Not less than 480IU/mg 574IU/mg PT/QC/OT/01-11
Specific Optical Rotation -19.5 to -23.5 -21.5 PT/QC/OT/01-12
Residual solvent
Methanol
Acetonitrile
Triethylamine
 
NMT 3000ppm
NMT 410 ppm
NMT 320 ppm
 
Less than LOD 32ppm
Less than LOD 90ppm
Less than LOD 14ppm
PT/QC/OT/01-13
 
Our company was established in 2006. As an integrated company, we are specializing in Pharmaceuticals( Peptides), Food Additives, Feed Additives. We have established extensive and pleasant working ties with many manufacturers within China on a long-term basis and enjoyed a reliable marketing network in Asia, Europe, America, Africa and Oceania.

We establish a high-technology enterprise specialized in the research and development of Peptide Drugs. We devote ourselves to the research and development of new Gene Protein drugs and unnatural amino acid as well as supplying of

Customized peptide.

We have more than 20 experienced R&D staffs, one R&D center and one GMP standard factory in Hangzhou, also

One new GMP standard factory with more than 5000 square meters in Shaoxing is under establishment.

Qualified products, the best service and innovation is our concept and life.

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