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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

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