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ACTH (Corticotropin) specifications:

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Molecular weight: 4567.6 (free peptide)
ACTH (Corticotropin)
Sequence:		 H-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-Lys-
Pro-Val-Gly-Lys-Lys-Arg-Arg-Pro-Val-Lys-Val-
Tyr-Pro-Asn-Gly-Ala-Glu-Asp-Glu-Leu-Ala-Glu-
Ala-Phe-Pro-Leu-Glu-Phe-OH
Last update: 30 AUG 2007

Available registration documents (CTD format): None, the substance is sold based on its CoA

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 amorphous powder of low density

 Visual inspection
IDENTIFICATION
Amino acid analysis

Asp: 1.8 to 2.2
Glu: 4.5 to 5.5
Pro: 3.6 to 4.4
Gly: 2.7 to 3.3
Val: 2.7 to 3.3
Leu: 1.8 to 2.2
His: 0.9 to 1.1
Arg: 2.7 to 3.3
Lys: 3.6 to 4.4
Ser: 1.8 to 2.2
Met: 0.9 to 1.1
Tyr: 1.8 to 2.2
Phe: 2.7 to 3.3
Ala: 2.7 to 3.3
Trp: 0.9 to 1.1

 In-house
Identification, HPLC

Conforms to reference standard

 In-house

Other specifications of ACTH (Corticotropin) synthetic:


PURITY
Peptide purity, HPLC: ≥ 95% In-house
ASSAY
Potency, HPLC ≥ 70 IU/mg In-house
OTHER TESTS
Acetic acid < 15% In-house
Water ≤ 7% USP/Ph.Eur.
Trifluoroacetic acid ≤ 0.3% In-house
RESIDUAL SOLVENTS
N,N-Dimethyl-
formamide		 ≤ 880 ppm In-house
Methanol ≤ 0.3% In-house
Diethyl ether ≤ 0.5% In-house
MICROBIOLOGICAL TESTS
Total viable aerobic count < 102 CFU/g Ph.Eur.
Bacterial endotoxins

≤ 318 IU/mg

 USP/Ph.Eur.

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