Oxytocin (Oxytocin Acetate)
Oxytocin acetate is a mammalian hormone that acts primarily as a neurotransmitter in the brain. Also known as alpha-hypophamine (α–hypophamine), oxytocin has the distinction of being the very first polypeptide hormone to be sequenced and synthesized biochemically by Vincent du Vigneaud et al. in 1953.
CAS 50-56-6
Oxytocin (Oxytocin Acetate)Appearance: White to off-white, amorphous powder
Identity by MS: 1007.231
Identification: A: Retention time conforms to that of reference
B: Bioidentity: rat test
PH: 3.0~6.0
Amino Acids: Asp: 0.95-1.05
Glu: 0.95-1.05
Pro: 0.95-1.05
Gly: 0.95-1.05
Leu: 0.90-1.05
Tyr: 0.70-1.05
Cys: 1.4-2.1
He: 0.9-1.10
Oxytocic Activity: 400IU/mg Min
Ordinary Impurities:
Single Impurity: 1.5% Max
Total Impurity: 5.0% Max
HAc: 10% Max
Water: 5.0% Max
Bacterial : 300IU/mg
Vasopressor Activity: 0.1 units/ml
Peptide Purity: 95.0% Min
Microbial limits: 200cfu/g Max
Salmonella & coli: Absent
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TEST
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SPECIFICATION
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RESULTS
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1. Characteristic
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White or almost white powder.
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White powder
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2. Identification
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Conforms
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A. HPLC
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Retention time conforms to that of the reference standard
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B. Amino acids
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Asp: 0.90-1.10;Glu: 0.90-1.10
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Conforms
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Pro: 0.90-1.10;Gly: 0.90-1.10
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Leu: 0.90-1.10;Tyr: 0.7-1.05
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Half-Cys: 1.4-2.1;Ile: 0.90-1.10
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3. pH
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3.0-6.0
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5
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4. Related substances (HPLC)
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Impurity A≤1.5%
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0.15%
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Impurity B≤1.5%
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0.20%
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Impurity C≤1.5%
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Not Detected
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Other single impurity≤0.5%
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0.13%
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Total impurities≤5.0%
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0.70%
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5. Acetic acid (HPLC)
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6.0%-10.0%
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7.10%
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6. Water(KF)
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NMT 5.0%
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1.40%
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7. Bacterial endotoxins
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Less than 300 IU/mg
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Conforms
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8. AcN(GC)
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Not more than 0.041%
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Conforms
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9. MeOH(GC)
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Not more than 0.3%
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Conforms
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10. Triethylamine(GC)
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Not more than 0.032%
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Conforms
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11. Assay
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98.80%
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Calculated with reference to anhydrous, acetic acid free substance
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93.0%-102.0%
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on powder
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NLT 80.0 %
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90.40%
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NLT 480 IU/mg
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542IU/mg
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