Calcitonin: US Specification
View EU Specification
PDF Version [44 KB PDF]
| Molecular weight: | 3432 (as free base) | |
|---|---|---|
| Calcitonin Sequence: |
_____________________ | | H-Cys-Ser-Asn-Leu-Ser-Thr-Cys- Val-Leu-Gly-Lys-Leu-Ser-Gln-Glu- Leu-His-Lys-Leu-Gln-Thr-Tyr-Pro- Arg-Thr-Asn-Thr-Gly-Ser-Gly-Thr- Pro-NH2 Acetate salt |
|
| Last update: | 15 MAR 2010 | |
| Available registration documents (CTD format): US DMF |
||
| TEST | ACCEPTANCE CRITERIA | ANALYTICAL PROCEDURE |
|---|---|---|
| CHARACTERISTICS | ||
| Appearance |
White or almost white powder.
Freely soluble in water. |
Visual inspection USP |
| IDENTIFICATION | ||
| Identification, HPLC |
Retention time of the principle peak in the sample is similar to the retention time of the principle peak in the reference
|
USP |
| Amino acid analysis |
Asp: 1.8 to 2.2
Glu: 2.7 to 3.3 Pro: 1.7 to 2.3 Gly: 2.7 to 3.3 Val: 0.9 to 1.1 Leu: 4.5 to 5.3 His: 0.9 to 1.1 Arg: 0.9 to 1.1 Lys: 1.8 to 2.2 Ser: 3.2 to 4.2 Thr: 4.2 to 5.2 Tyr: 0.7 to 1.1 Half-cystine: 1.4 to 2.1 |
USP |
| Bioidentity | The potency levels determined from all three performances of the test are homogeneous, and the confidence limits for all three determinations are between 64% and 156% of the calculated potency | USP |
Other specifcations of Calcitonin:PURITY |
||
| Peptide purity, HPLC: | ≥ 97.0% | USP |
| Peptide related impurities, HPLC: | USP | |
| RRt approx. 0.84 (molecular weight 3473.7 and 3431.7) | ≤ 0.3% | |
| RRt approx. 0.92 (molecular weight 3431.7) | ≤ 0.3% | |
| RRt approx. 0.95 (molecular weight 3463.7) | ≤ 0.3% | |
| Sum of identified related peptides with RRt approx. 1.05 to 1.07 |
≤ 1.0% | |
| [Glu14]-Calcitonin | ≤ 1.0% | |
| Sum of [Glu20]-Calcitonin and N-Acetyl-Cys(1)-Calcitonin | ≤ 1.0% | |
| [Glu20]-Calcitonin | ≤ 1.0% | |
| N-Acetyl-Cys(1)-Calcitonin | ≤ 1.0% | |
| Any unspecified impurities / degradation products | ≤ 0.2% | |
| Sum impurities / degradation products | ≤ 3.0% |
| ASSAY | ||
|---|---|---|
| Peptide content | Report result (%) | USP |
| Mass balance | 90.0 to 105.0% | USP |
| Biological activity Calculated as: (peptide content x 6000 IU/mg)/100 |
Report result, IU/mg | USP |
| OTHER TESTS | ||
| Chloride | ≤ 0.2% (w/w) | In-house |
| Water | ≤ 10% (w/w) | USP |
| Acetic acid | 4.0 to 15.0% (w/w) | USP |
| Heavy metals | ≤ 20 ppm (w/w) | In-house |
| RESIDUAL SOLVENTS | ||
| Trifluoroacetic acid | ≤ 100 ppm | In-house |
| Ethanol | ≤ 2000 ppm | In-house |
| Acetonitrile | ≤ 410 ppm | In-house |
| MICROBIOLOGICAL TESTS | ||
| Microbial enumeration tests: | USP | |
| TAMC | ≤ 100 CFU/g | |
| TYMC | ≤ 100 CFU/g | |
| Bacterial endotoxins | ≤ 1000 EU/mg |
USP |
Calcitonin: EU Specification
EU Specification PDF Version [44 KB PDF]
| Molecular weight: | 3432 (as free base) | |
|---|---|---|
| Calcitonin Sequence: |
_____________________ | | H-Cys-Ser-Asn-Leu-Ser-Thr-Cys- Val-Leu-Gly-Lys-Leu-Ser-Gln-Glu- Leu-His-Lys-Leu-Gln-Thr-Tyr-Pro- Arg-Thr-Asn-Thr-Gly-Ser-Gly-Thr- Pro-NH2 Acetate salt |
|
| Last update: | 15 MAR 2010 | |
| Available registration documents (CTD format): CEP/COS certificate |
||
| TEST | ACCEPTANCE CRITERIA | ANALYTICAL PROCEDURE |
|---|---|---|
| CHARACTERISTICS | ||
| Appearance |
White or almost white powder. Freely soluble in water.
|
Ph.Eur. |
| IDENTIFICATION | ||
| Identification, HPLC |
Retention time of the principle peak in the sample is similar to the retention time of the principle peak in the reference
|
Ph.Eur. |
| Amino acid analysis |
Asp: 1.8 to 2.2
Glu: 2.7 to 3.3 Pro: 1.7 to 2.3 Gly: 2.7 to 3.3 Val: 0.9 to 1.1 Leu: 4.5 to 5.3 His: 0.9 to 1.1 Arg: 0.9 to 1.1 Lys: 1.8 to 2.2 Ser: 3.2 to 4.2 Thr: 4.2 to 5.2 Tyr: 0.7 to 1.1 Half-cystine: 1.4 to 2.1 |
Ph.Eur. |
Other specifcations of Calcitonin:PURITY |
||
| Peptide purity, HPLC: | ≥ 95.0% | Ph.Eur. |
| Related substances, HPLC: | Ph.Eur. | |
| O-acetylated Calcitonin with co-eluting peaks (Impurity D in monograph) |
≤ 3.0% |
|
| Sum of [Glu20]-Calcitonin and N-Acetyl-Cys(1)-Calcitonin (Impurity A in monograph) |
≤ 0.3% |
|
| Unspecified impurities/degradation products | ≤ 0.3% | |
| Sum of impurities/degradation products | ≤ 5.0% |
| ASSAY | ||
|---|---|---|
| Mass balance | 90.0 to 105.0% | Ph.Eur. |
| OTHER TESTS | ||
| Chloride | ≤ 0.5% (w/w) | In-house |
| Water | ≤ 10% (w/w) | Ph.Eur. |
| Acetic acid | 4.0 to 15.0% (w/w) | Ph.Eur. |
| Acetic acid and water | ≤ 20% (w/w) | Ph.Eur. |
| RESIDUAL SOLVENTS | ||
| Trifluoroacetic acid | ≤ 100 ppm | In-house |
| Ethanol | ≤ 5000 ppm | In-house |
| Acetonitrile | ≤ 400 ppm | In-house |
| MICROBIOLOGICAL TESTS | ||
| Microbial enumeration tests | Ph.Eur. | |
| TAMC | ≤ 100 CFU/g | |
| TYMC | ≤ 100 CFU/g | |
| Bacterial endotoxins | < 25 IU/mg |
Ph.Eur. |
For more information on Calcitonin, samples or orders contact us.
