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All ergometrine ampoules were outside specification for active ingredient.
All the oxytocin ampoules from unregistered manufacturers were outside specification for active ingredient.
Inactive uterotonics are not restricted to the private sector; uterotonics outside specification were purchased from private and public sources.
Of 46 pharmacy-pairs of oxytocin ampoules from Karnataka, in only five pairs was one within manufacturer specification and the other outside specification.
One third of the oxytocin ampoules from manufacturers with pending registration status were outside specification for active ingredient (data not shown).
The main reason for screen-failure was that the HbA1c fell outside protocol specifications.
The percent of oxytocin ampoules outside manufacturer specifications (90%-110% API) ranged from 33%-40 33%-40rnataka and from 22%-50% in Uttar Pradesh.
Retrospective review of DICOM headers in the six test data scans revealed that in three data sets the UT was outside the specifications in the IG.
However, even the best-case scenario (in Gorakhpur, Uttar Pradesh) suggests that one in five ampoules of oxytocin available to the population in private pharmacies may be outside manufacturer specifications for API.
It was not possible to assess general adherence to information given in the patient information leaflets or whether advice was sought prior to using a product outside the specifications, but parents of young children should be encouraged to follow the labelling advice or seek advice from a health professional.
27 On the other hand, Yong and others obtained samples of antibiotics and antimalarials from seizures conducted by Interpol and medicine regulatory authorities and observed that one-third of all antibiotic and antimalarial samples had API compositions outside pharmacopeial specifications (< 85% or > 115% API).
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