Oxytocin Acetate

Certificate of Analysis for Oxytocin EP7 standard :

Name of Product:

Oxytocin

Cys-Tyr-Ile-Gln-Asn-Cys-Pro-Leu-Gly-NH2

Batch No:            

120202

Analyzed on:

2012-2-29

Date of Manufacture:

2012-2-20

Quantity:

30g

CAS No.:

[50-56-6]

Expiry Date:

2014-2-19

TEST

SPECIFICATION

 RESULTS

1. Characteristic

White or almost white powder.

White powder

2. Identification

  A. HPLC

Retention time conforms to that of the 

reference standard

Conforms

B. Amino acids

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;Tyr: 0.7-1.05

Half-Cys: 1.4-2.1;Ile: 0.90-1.10

Conforms

3. pH

3.0-6.0

5.0

4. Related substances (HPLC)

Impurity A≤1.5%

0.15%

Impurity B≤1.5%

0.20%

Impurity C≤1.5%

Not Detected

Other single impurity≤0.5%

0.13%

Total impurities≤5.0%

0.7%

5. Acetic acid (HPLC)

6.0%-10.0%

7.1%

6. Water(KF)

NMT 5.0%

1.4%

7. Bacterial endotoxins

Less than 300 IU/mg

Conforms

8. AcN(GC)

Not more than 0.041%

Conforms

9. MeOH(GC)

Not more than 0.3%

Conforms

10. Triethylamine(GC)

Not more than 0.032%

Conforms

11. Assay

Calculated with reference to anhydrous, 

acetic acid free substance

93.0%-102.0% 

98.8%

on powder

NLT 80.0 %

90.4%

NLT 480 IU/mg

542IU/mg