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Additional physico-chemical information

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Reference
Endpoint:
additional physico-chemical information
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 16, 1995 to April 15, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in a GLP certified laboratory.
Principles of method if other than guideline:
AHTN (phenyl UL-14C) was analyzed for radiochemical purity and stability using reverse-phase HPLC with a radiochemical detector.
GLP compliance:
yes
Endpoint investigated:
other: purity
Results:
Each sample showed an average percent radiochemical purity of >=97.89%.

Table 1: Percent Purity from HPLC Analysis

Date % of area replicates Average s.d. RSD (%)
16 May 95 99.06 95.21 99.41 97.89 2.33 2.38
7 June 95 98.71 98.79 98.47 98.66 0.17 0.17
16 June 95 100.00 97.65 99.90 99.18 1.33 1.34
12 March 96 100.00 100.00 100.00 100.00 0.00 0.00
8 April 96 99.57 99.60 100.00 99.72 0.24 0.24
15 April 96 100.00 100.00 98.91 99.64 0.63 0.63
Conclusions:
Based on the results, the average percent radiochemical purity of AHTN (phenyl-UL-14C) was >=97.89%.
Executive summary:

Using reverse-phase HPLC with a radiochemical detector on AHTN samples taken over the period from May 16, 1995 to April 15, 1996, the average percent radiochemical purity of AHTN (phenyl-UL-14C) was >=97.89%.

Description of key information

The test item was analysed for radiochemical purity and stability using reverse-phase HPLC with a radiochemical detector. Each sample showed an average percent radiochemical purity of >=97.89%.

Additional information