Table 2.
Investigated oxytocin samples
| Collected in | Stated manufacturer (and brand name, if not marketed under INN) | Country of manufacture | Expiry date | Batch number | Stated shelf life (years) | Stated storage requirements (°C) | Stated (or detected) excipients | Prequalification status | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Water for inj. | Chlorobutanol (mg/mL) | Sodium acetate | Acetic acid | Sodium hydroxide | Sodium chloride | Citric acid | Others | ||||||||
| Malawi | Ningbo Pharma Biotech Co., Ltd. (WW-Oxy 10) | China | August 19 | 160802 | 3 | Less than 25 | + | – | – | – | – | – | – | +* | None |
| January 19 | 160183 | ||||||||||||||
| Umedica Laboratories Pvt. Ltd. | India | January 20 | JA802 | 2 | Not exceeding 30 | + | 1.5† | – | – | – | – | – | +* | None | |
| Ciron Drugs & Pharmaceuticals Pvt. Ltd. | India | August 19 | 7EA01228 | 2 | 2–8 | +‡ | 5† | – | – | – | – | – | – | None | |
| Biologici Italia Laboratories S.r.l. | Italy | March 19 | UF602ON | 3§ | 2–8 | + | – | + | + | + | – | – | – | SRA | |
| Rwanda | Laboratoires STEROP | Belgium | August 19 | 160269 | 3 | 2–8 | + | 5 | – | – | – | + | + | – | SRA |
| Laboratoires STEROP (Steroxine 10 IU/1 mL)‖ | January 19 | 160042 | |||||||||||||
| Rotexmedica GmbH Arzneimittelwerk | Germany | September 20 | 70779A | 3 | 2–8 | + | – | + | + | – | + | – | – | SRA | |
| AS Grindeks | Latvia | November 20 | 37711116 | 4 | 2–8 | + | – | + | + | + | + | – | – | WHO-PQ | |
| Europe | AS Grindeks | September 21 | 38910917 | ||||||||||||
| Hexal AG | Germany | June 20 | HC0075 | 3¶ | 2–8 | + | – | – | + | – | + | – | – | SRA | |
WHO-PQ = WHO-prequalified product; SRA = produced in a country with stringent regulatory authority. All samples represented 1 mL vials with a stated content of 10 IU oxytocin/mL.
High-performance liquid chromatography (HPLC) analysis showed additional peaks, indicating additional, unidentified ingredients.
Chlorobutanol not declared but detected in HPLC analysis.
Water for inj. not explicitly declared.
Manufacturing date not stated on the packaging; information received from the websites of the British Medicines and Healthcare products Regulatory Agency (http://www.mhra.gov.uk) and the Irish Health Products Regulatory Authority (http://www.hpra.ie/).
One branded and one unbranded generic oxytocin product of Laboratoires STEROP were found in Rwanda, with identical composition.
Manufacturing date not stated on the packaging but received from the manufacturer.