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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.

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