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Molecular weight: 4117.8 (free peptide)
Sequence: H-Ser-Val-Ser-Glu-Ile-Gln-Leu-
Met-His-Asn-Leu-Gly-Lys-His-Leu-
Asn-Ser-Met-Glu-Arg-Val-Glu-Trp-
Leu-Arg-Lys-Lys-Leu-Gln-Asp-Val-
His-Asn-Phe-OH,
supplied as acetate salt
Last update: 30 AUG 2007

Available registration documents (CTD format): Contact PolyPeptide Laboratories

Please note that regional minor differences in analytical procedures and acceptance criteria might occur.


TEST ACCEPTANCE CRITERIA ANALYTICAL PROCEDURE
CHARACTERS
Appearance

White to off-white powder

Visual inspection
Solubility

Soluble in 1% acetic acid at a concentration of 1 mg/mL to give a clear, colorless solution

Ph.Eur.
IDENTIFICATION
Identification, MS

Monoisotopic mass
4115.1 ± 1

In-house
Amino acid analysis

Asx: 3.6 to 4.4
Ser: 2.55 to 3.45
Glx: 4.5 to 5.5
Gly: 0.9 to 1.1
Val: 2.55 to 3.45
Met: 1.8 to 2.2
Ile: 0.85 to 1.15
Leu: 4.5 to 5.5
Phe: 0.9 to 1.1
His: 2.7 to 3.3
Lys: 2.7 to 3.3
Trp: 0.4 to 1.15
Arg: 1.8 to 2.2

In-house
Identification, HPLC

Co-elutes with reference standard
System I and XI

In-house
PURITY
Peptide purity, HPLC: ≥ 98.5%
System I and XI
  In-house
Related substances, HPLC:    
Total amount ≤ 1.5%  
Any individual impurity ≤ 0.5%  
  System I and XI In-house
ASSAY
Mass balance 95 to 105% Calculation
OTHER TESTS
Acetic acid ≤ 10% In-house
Water ≤ 10% USP/Ph.Eur.
Specific optical rotation
[α]20D
(c = 0.1, 1% acetic acid)
Report result (corrected for water and acetate) In-house
Trifluoroacetic acid ≤ 0.25% In-house
Perchlorate ≤ 0.1% In-house
RESIDUAL SOLVENTS
Any individual residual solvent ≤ 0.1% In-house
MICROBIOLOGICAL TESTS
Total viable aerobic count Report result (CFU/g) In-house
Bacterial endotoxins

Report result (IU/mg)

USP/Ph.Eur.
Visit our Online Catalogue of Biologically Active Peptides