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Re: N-acetyl-L-cysteine as antioxidant

    Dear Colleagues,
    N-acetyl-L-cysteine was used in an ophthalmic product containining 
Guanidine and Adrenaline.  Its use was as an anti-oxidant.  I do not
brand name at this time.
Satish Shirolkar

   Dear colleagues

    This is the first time I am contributing to this excellent
    discussion forum and would like to kick off with the following:
    Can anyone update me on the regulatory status of acetylcysteine
    (N-acetyl-L-cysteine) as ANTIOXIDANT for parenteral solutions?
    There are numerous references in textbooks and in the scientific
    literature citing its use as such in injectable products.  Notably
    the following:  Pharmaceutical Dosage Forms-Parenteral Medications
    Volume 1 Edited by Avis, Lachman and Lieberman. Marcel Dekker 1984

    and a number of publications by respected parenteral formulation
    scientists (e.g. Michael J. Akers et al). Yet, despite its
    apparent widespread use, it would appear that it is not formerly
    recognised by the regulatory authorities as an anti-oxidant as
    such (USPNF/BP or EU?). In view of its intravenous use at much
    higher levels as a therapeutic substance (treatment of paracetamol
    poisoning), what are the regulatory implications?  What are the
    concentration limits as an antioxidant?  Is anyone at liberty to
    provide examples of registered small volume parenteral products
    which are stabilised by acetylcysteine?

    Thank you

    Dr Darryl V. Whittaker
    c/o Druggists Group Research
    A Division of Pharmacare Ltd, South Africa
    P.O. Box 4002
    Port Elizabeth
    e-mail darrylw@lennon.pharmacare.co.za

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