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

From: Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage

Pharmacopeia Storage conditions Assay Related substances/Impurities
API FPP API FPP API 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
  1. NLT not less than, NMT not more than, IU international unit, NM No monograph