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. |
