Skip to content

We are pleased to announce that the PolyPeptide Group received the certificate granted by the European Directorate for the Quality of Medicines for Generic Desmopressin on December 22, 2008. Certificate number: RO-CEP 2006-266-Rev 00.

View EU Specification

Desmopressin: US Specification

PDF Version [36 KB PDF]

Molecular weight: 1069 (as free base)
Desmopressin
Sequence:
  _________________________
  |                                                 |
SCH2CH2CO-Tyr-Phe-Gln-Asn-Cys-
Pro-D-Arg-Gly-NH2 Acetate salt
Last update: 15 MAR 2010
Available registration documents (CTD format): US DMF
 

TEST ACCEPTANCE CRITERIA ANALYTICAL PROCEDURE
CHARACTERISTICS
Appearance
A white powder

 
Visual inspection
IDENTIFICATION
Monoisotopic mass, MS 169.4 = 0.5 USP
MS/MS Product ions at m/z of about 641, 742 and 995 are present  
HPLC
Retention time of main peak corresponds to the retention time of reference

 
In-house
Amino acid analysis
Asp: 0.95 to 1.05
Glu: 0.95 to 1.05
Pro: 0.95 to 1.05
Gly: 0.95 to 1.05
Cys: 0.95 to 1.05
Tyr: 0.95 to 1.05
Phe: 0.95 to 1.05
Arg: 0.95 to 1.05
Not more than traces of other amino acids are present

 
USP

Other specifications of Desmopressin:


PURITY
Peptide related impurities, HPLC:     In-house
[Asp5]desmopressin ≤ 0.4%  
[Glu4]desmopressin ≤ 0.4%  
[Gly9OH]desmopressin ≤ 0.4%  
[L-Arg8]desmopressin ≤ 0.4%  
[Gln4(Acm)]desmopressin and    
[Asn5(Acm)]desmopressin ≤ 0.4%  
[Gly9N(CH3)2]desmopressin ≤ 0.4%  
Any unspecified impurity ≤ 0.3%  
Sum of impurities < 1.5%  
ASSAY
Peptide content, HPLC 95.0 to 105.0% of desmopressin calculated with reference to the anhydrous, acetic acid/acetate free substance In-house
OTHER TESTS
Acetic acid content 3.0 to 8.0% USP
Water content ≤ 6.0% w/w USP
Specific optical rotation 589 nm: -82 to -72
calculated with reference to the anhydrous, acetic acid/acetate free substance
USP
RESIDUAL SOLVENTS
Ethanol ≤ 0.5% In-house
MICROBIOLOGICAL TESTS
Microbial enumeration tests:

TAMC
TYMC




≤ 100 CFU/g
≤ 100 CFU/g
USP
Bacterial endotoxins < 500 EU/mg

 
USP


 
 

Desmopressin: EU Specification

EU Specification PDF Version [40 KB PDF]

Molecular weight: 1069 (as free base)
Desmopressin
Sequence:
  _________________________
  |                                                 |
SCH2CH2CO-Tyr-Phe-Gln-Asn-Cys-
Pro-D-Arg-Gly-NH2 Acetate salt
Last update: 15 MAR 2010
Available registration documents (CTD format): CEP/COS certificate
 

TEST ACCEPTANCE CRITERIA ANALYTICAL PROCEDURE
CHARACTERISTICS
Appearance
A white powder

 
Visual inspection
IDENTIFICATION
HPLC
Retention time and size of main peak correspond to that of reference

 
In-house
Amino acid analysis
Asp: 0.95 to 1.05
Glu: 0.95 to 1.05
Pro: 0.95 to 1.05
Gly: 0.95 to 1.05
Cys: 0.95 to 1.05
Tyr: 0.95 to 1.05
Phe: 0.95 to 1.05
Arg: 0.95 to 1.05
Not more than traces of other amino acids are present

 
Ph.Eur.

Other specifications of Desmopressin:


PURITY
Peptide related impurities, HPLC:     In-house
A [Asp5]desmopressin ≤ 0.4%  
B [Glu4]desmopressin ≤ 0.4%  
C [Gly9OH]desmopressin ≤ 0.4%  
D [L-Arg8]desmopressin ≤ 0.4%  
E [Gln4(Acm)]desmopressin and    
F [Asn5(Acm)]desmopressin ≤ 0.4%  
G [Gly9N(CH3)2]desmopressin ≤ 0.4%  
Any unspecified impurity ≤ 0.3%  
Sum of impurities ≤ 1.5%  
ASSAY
Peptide content, HPLC 95.0 to 105.0% of desmopressin calculated with reference to the anhydrous, acetic acid/acetate free substance In-house
OTHER TESTS
Acetic acid content 3.0 to 8.0% Ph.Eur.
Water content ≤ 6.0% w/w Ph.Eur.
Specific optical rotation 589 nm: -82 to -72 Ph.Eur.
RESIDUAL SOLVENTS
Ethanol ≤ 0.5% In-house
MICROBIOLOGICAL TESTS
Microbial enumeration tests:

TAMC
TYMC




< 100 CFU/g
< 100 CFU/g
Ph.Eur.
Bacterial endotoxins < 500 IU/mg

 
Ph.Eur.
For more information on Desmopressin, samples or orders contact us.