1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one

Additional physico-chemical information

Link to relevant study record(s)

Reference

Endpoint:

other: purity

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

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%.