DBL HEPARIN SODIUM (porcine mucous) 5000IU/0.2 mL injection BP ampoule, Pfizer Australia Pty Ltd, CON-964
Product name
DBL HEPARIN SODIUM (porcine mucous) 5000IU/0.2 mL injection BP ampoule
Sponsor name
Pfizer Australia Pty Ltd
Batches
14 batches of the product manufactured and released to market after 30 June 2022 until 31 March 2023.
Consent start
Consent no.
CON-964
Standard
The product does not conform to the requirements of the British Pharmacopoeia 2022
Non-compliance with standard
The product conforms to the requirements of the British Pharmacopeia 2021 rather
than the British Pharmacopeia 2022. The differences between the compendial
versions are (i) identification testing using electrophoresis rather than
nuclear magnetic resonance spectrometry and (ii) change to the HPLC gradient
ratio and change to the limit for any other peak for the Related Substance test
a disregard limit of 0.02% corresponding to any other impurity rather than no
peaks other than the peak due to dermatan sulfate and chondroitin sulfate are
detected.
Therapeutic product type
Prescription medicines