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.