Materials
Individual batches of two OXY products and 18 TXA products of 100mg/mL
were used in Part 2 of the study as shown in Tables 2. All batches were
tested for quality against the BP specifications for assay and related
substances prior to study start. Both OXY products passed quality
testing against the BP specification in terms of assay and related
substances but neither was quality assured through listing under the WHO
prequalification programme or approval by a SRA. TXA products marked
with a single asterisk failed quality testing in terms of TXA content,
while those marked with two asterisks failed total impurity
specifications. One TXA product (TXA 8) was quality-assured product
manufactured by the innovator company.