View EU Specification
Desmopressin: US Specification
PDF Version [36 KB PDF]
| Molecular weight: | 1069 | |
|---|---|---|
| Desmopressin Sequence: |
_________________________ | | SCH2CH2CO-Tyr-Phe-Gln-Asn-Cys- Pro-D-Arg-Gly-NH2 Acetate salt |
|
| Last update: | 12 SEP 2007 | |
| Available registration documents (CTD format): US DMF, CEP/COS certificate Please note that regional minor differences in analytical procedures and acceptance criteria might occur. |
||
| TEST | ACCEPTANCE CRITERIA | ANALYTICAL PROCEDURE |
|---|---|---|
| CHARACTERS | ||
| Appearance |
A white powder
|
Visual inspection |
| IDENTIFICATION | ||
| Identification, HPLC |
Retention time of main peak corresponds to the retention time of reference sample
|
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 |
Ph.Eur. |
Other specifications of Desmopressin:PURITY |
||
| Related substances, HPLC: | In-house | |
| Any individual impurity | ≤ 0.5% | |
| Total amount | ≤ 1.5% |
| ASSAY | ||
|---|---|---|
| Mass balance | 95.0 to 105.0% | Calculation |
| OTHER TESTS | ||
| Acetic acid | 3.0 to 8.0% | Ph.Eur. |
| Water | ≤ 6.0% | USP/Ph.Eur. |
| Specific optical rotation | -82 to -72 | USP/Ph.Eur. |
| RESIDUAL SOLVENTS | ||
| Ethanol | ≤ 0.5% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | < 100 CFU/g | USP/Ph.Eur. |
| Bacterial endotoxins | < 500 IU/mg |
USP/Ph.Eur. |
Desmopressin: EU Specification
EU Specification PDF Version [40 KB PDF]
| Molecular weight: | 1069 | |
|---|---|---|
| Desmopressin Sequence: |
_________________________ | | SCH2CH2CO-Tyr-Phe-Gln-Asn-Cys- Pro-D-Arg-Gly-NH2 Acetate salt |
|
| Last update: | 12 SEP 2007 | |
| Available registration documents (CTD format): CEP/COS certificate Please note that regional minor differences in analytical procedures and acceptance criteria might occur. |
||
| TEST | ACCEPTANCE CRITERIA | ANALYTICAL PROCEDURE |
|---|---|---|
| CHARACTERS | ||
| Appearance |
A white powder
|
Visual inspection |
| IDENTIFICATION | ||
| 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 |
Ph.Eur. |
Other specifications of Desmopressin:PURITY |
||
| Related substances, 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 other individual impurity | ≤ 0.3% | |
| Total amount | ≤ 1.5% |
| ASSAY | ||
|---|---|---|
| Mass balance | 95.0 to 105.0% | Calculation |
| OTHER TESTS | ||
| Acetic acid | 3.0 to 8.0% | Ph.Eur. |
| Water | ≤ 6.0% | USP/Ph.Eur. |
| Specific optical rotation | -82 to -72 | USP/Ph.Eur. |
| RESIDUAL SOLVENTS | ||
| Ethanol | ≤ 0.5% | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | < 100 CFU/g | USP/Ph.Eur. |
| Bacterial endotoxins | < 500 IU/mg |
USP/Ph.Eur. |
