Table 2 Select pharmacopeia monograph quality specifications for oxytocin API and FPP

United States Pharmacopeia 40

Refrigerated, 2-8 °C

No specification provided

NLT 90.0 and NMT 110.0%

NLT 400 USP Oxytocin units per mg

Total impurities NMT 5%

No specification provided

European Pharmacopeia, 9th Ed

2-8 °C, protect from light

NM

NLT 93.0% and NMT 103.0%

NM

Any individual impurity NMT 1.5%;

NM

Total impurities NMT 5%

International Pharmacopeia, 2017, 7th Ed

2-8 °C, protect from light

Unless otherwise indicated on the label, 2-8 °C, The manufacturer may provide additional information on the label regarding storage conditions for a specified period which may differ from the long-term storage conditions.

NLT 93.0% and NMT 103.0%

NLT 90.0% and NMT 110.0%

Any individual impurity NMT 1.5%;

Any individual impurity NMT 1.5%;

Total impurities NMT 5%

Total impurities NMT 5%

British Pharmacopeia, 2018

2-8 °C, protect from light

No specification provided

NLT 93.0% and NMT 103.0%

NLT 90.0% and NMT 110.0%

Any individual impurity NMT 1.5%;

No specification provided

Total impurities NMT 5%

Japanese Pharmacopeia, 2016, 17th Ed,

2-8 °C,

In a cold place (1-15 °C), avoid freezing

NLT 540 oxytocin Units and NMT 600 oxytocin Units

NLT 90.0% and NMT 110.0%

Any individual impurity NMT 1.5%;

No specification provided

Total impurities NMT 5%

Indian Pharmacopeia 2014

Store protected from moisture

No storage requirements provided

NLT 95.0% and NMT 105.0%

NLT 90.0% and NMT 110.0%

No specification provided

No specification provided