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US Specification
PDF Version [44 KB PDF]
| Molecular weight: | 3432 | |
|---|---|---|
| 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: | 12 SEP 2007 | |
|
Available registration documents (CTD format): US DMF Please note that regional minor differences in analytical procedures and acceptance criteria might occur. |
||
| TEST | ACCEPTANCE CRITERIA | ANALYTICAL PROCEDURE |
|---|---|---|
| CHARACTERS | ||
| Appearance | White or almost white powder. Freely soluble in water. |
Visual inspection |
| IDENTIFICATION | ||
| Identification, TLC |
Complies with reference |
In-house |
| 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 |
Ph.Eur. |
| PURITY | ||
| Peptide purity, HPLC: | ≥ 97.0% | Ph.Eur. |
| Related substances, HPLC: | Ph.Eur. | |
| RRt 0.84 (molecular weight | ||
| 3473.7 and 3431.7) | ≤ 0.3% | |
| RRt 0.92 (molecular weight | ||
| 3431.7) | ≤ 0.3% | |
| RRt 0.95 (molecular weight | ||
| 3463.7) | ≤ 0.3% | |
| Sum of identified related peptides with RRt 1.05 to 1.07 |
||
| (Impurity D in monograph) | ≤ 1.0% | |
| [Glu14]-Calcitonin | ≤ 1.0% | |
| Sum of [Glu20]-Calcitonin and | ||
| N-Acetyl-Cys(1)-Calcitonin | ||
| (Impurity A in monograph) | ≤ 1.0% | |
| [Glu20]-Calcitonin | ≤ 1.0% | |
| N-Acetyl-Cys(1)-Calcitonin | ||
| (Impurity A in monograph) | ≤ 1.0% | |
| Any other individual impurity | ≤ 0.2% | |
| Total amount | ≤ 3.0% |
| ASSAY | ||
|---|---|---|
| Peptide content | Report result (%) | Ph.Eur. |
| Mass balance | 90.0 to 105.0% | Calculation |
| OTHER TESTS | ||
| Chloride | ≤ 0.2% | In-house |
| Water | ≤ 10% | USP/Ph.Eur. |
| Acetic acid | 4.0 to 15.0% | Ph.Eur. |
| Acetic acid and water | ≤ 20% | Ph.Eur. |
| pH of 1 % (w/V) solution in water | 4.9 to 5.7 | Ph.Eur. |
| Heavy metals | ≤ 20 ppm | In-house |
| Trifluoroacetic acid | ≤ 100 ppm | In-house |
| RESIDUAL SOLVENTS | ||
| Ethanol | ≤ 0.2% | In-house |
| Acetonitrile | ≤ 0.04% | In-house |
| Methylene chloride | ≤ 600 ppm | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | < 100 CFU/g | USP/Ph.Eur. |
| Bacterial endotoxins |
< 25 IU/mg |
USP/Ph.Eur. |
EU Specification
EU Specification PDF Version [44 KB PDF]
| Molecular weight: | 3432 | |
|---|---|---|
| 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: | 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 | White or almost white powder. Freely soluble in water. |
Visual inspection |
| 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 |
Ph.Eur. |
| 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% |
|
| Any other individual impurity | ≤ 0.3% | |
| Total amount | ≤ 5.0% |
| ASSAY | ||
|---|---|---|
| Mass balance | 90.0 to 105.0% | Calculation |
| OTHER TESTS | ||
| Chloride | ≤ 0.5% | In-house |
| Water | ≤ 10% | USP/Ph.Eur. |
| Acetic acid | 4.0 to 15.0% | Ph.Eur. |
| Acetic acid and water | ≤ 20% | Ph.Eur. |
| Trifluoroacetic acid | ≤ 100 ppm | In-house |
| RESIDUAL SOLVENTS | ||
| Ethanol | ≤ 5000 ppm | In-house |
| Acetonitrile | ≤ 400 ppm | In-house |
| MICROBIOLOGICAL TESTS | ||
| Total viable aerobic count | < 100 CFU/g | USP/Ph.Eur. |
| Bacterial endotoxins |
< 25 IU/mg |
USP/Ph.Eur. |
