Abstract:
:Methods were developed for the determination of octanoic acid and N-acetyl-DL-tryptophan, which are used as stabilizers in the human blood-derived therapeutic products normal serum albumin and plasma protein fraction. The method for octanoic acid uses GC; quantitation is achieved using heptanoic acid as the internal standard. The method for N-acetyl-DL-tryptophan is based on UV spectrophotometry of the acid-soluble fraction remaining after precipitation of the protein (epsilon 280 for N-acetyl-DL-tryptophan, 5250). The coefficient of variation for replicate determinations of octanoic acid averaged 3.9% (range 2.1-5.5%); that of N-acetyl-DL-tryptophan averaged 1.9% (range 0.5-4.0%). Use of these methods for the analysis of 138 lots of commercial products for octanoic acid and 159 lots for N-acetyl-DL-tryptophan showed that the stabilizer contents of 132 and 158 of these lots, respectively, were within 20% of the value indicated on the product label.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Yu MW,Finlayson JSdoi
10.1002/jps.2600730122subject
Has Abstractpub_date
1984-01-01 00:00:00pages
82-6issue
1eissn
0022-3549issn
1520-6017pii
S0022-3549(15)44924-Xjournal_volume
73pub_type
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