Document 7K83xZ9wNGRXL3QgnEbxZjE6
^Distribution
FROM
Scott Perry
SUBJECT
FIELD POINT OR DEPT & BLDG NO FIELD POINT OR DEPT & BLDG NO
D/5055
EXTRACTION TESTS ON VPK FILM
DATE YOUR LETTER
DATE THIS LETTER
2 July 1990
Attached is a copy of the Goodyear report on the determination of UV absorbers and permanganate oxidizables for our VPK film.
Scott Perry
Distribution; Sally Kline Joe Vyvoda Keith Gardner D'Lane Wisner Wally Bachtel
21640001
BFG-4956-NV 7/86 LITHO IN U.S.A.
BFG15815
9O183RDS0164
1 0OO6OS81
dw coulson, chem Technician!!! ROUTINE WORK REPORT
Chemical Analysis Section D415B
Reguostfi DO 1217
Charge#:
40121
Submitted by: JA Kay
(last name first)
3ubmissian Date; Needed by:
Completion Date:
86/23/so 062990
Phone#: Dept#:
7-6474 202e
Sample Type: oth Number of Samples submitted:
6
Location: 3
____
Userid: t202e06
Supervisor Userid: t202e06
TEQ:
____
(For Polyester)
TEST RESULTS
SUBJECT: FDA Approval of Semi Rigid Packaging Film.
SAMPLE DESCRIPTION: Pure water, heptane/ sample extracts in water and heptane, and blank extracts of each solvent.
SUMMARY:
The extracts and solvents were tested as prescribed in the Code of Federal Regulations, Title 21, -Section 177.1010. The packaging film was extracted in distilled water and heptane. Oxidizable extractables were determined by addition of potassium permanganate, uv absorbing species in these extracts were determined with spectrophotometric scans. Results were calculated as prescribed in the Code of Federal Regulations.
RESULTS AND DISCUSSION:
A Varian DMS 100 UV/VIX spectrophotometer was used for the UV scans. All the scans performed used a slit width of 0.5 nm and a 5 cm path. For both, the permanganate test and the UV absorbers test, separate blank corrections to be subtracted from the samples' absorbances were prepared for each solvent and scanned. Also, a separate correction factor for each test had to be developed for each solvent.
Z000S9TZ
JUL '90 14:29
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216 796 2617 FR6E.002
The following results were obtained trom test according to Title 21,, Section 177,1010:
A. Acceptability of solvents for use in UV absorption testing:
Maximum Absorbance Allowed
Water
0.03
Heptane:
280 to 310 nm
0.02
270 nm
0.04
260 nm
0.09
245 nm
0.15
Absorbance Maximum Obtained 0.005
0.040 0.048 0.058 0.083
B. Blank correction for the UV absorption test:
Water Heptane
Average Absorbance 0.004 0.006
C. Acceptability of solvents used in permanganate test:
Water
Specs
min.
max.
1.05
1.25
Absorbances Obtained
min.
max.
' 1.002
1.215
D. Blank correction for the permanganate test:
Water
Average Absorbance 0.001
E. Correction factors for permanganate test:
Specs
Absorbance Obtained
Min. A Max. A Min. A Max. A Av. A
Water 0.12
0.36 0.157 0.186 0.172
Correction Factor 1.40
F. Potassium permanganate oxidizable extractables test:
Water
Max. A Allowed Max. A in scan After Correction
0.15
0.001
0.000
G. Correcion factor tor the UV absorption test:
Absorbance max ca, 287 nm.
Specs at A Max
Min. A Max. A
0.08
0.14
Abs, Obtained at A Max. 0.108
Correction Factor 2.24
H. UV absorption test:
Water Heptane
Max A Allowed 0.30 0.10
Abs. at ca. 287 nm
0.050 0.012
After Correction
0.103 0.016
21640003
JUL
'90 14:29
BFG15817
21G 79G 2G17 PAGE.003
TO Distribution
FROM
Scott Perrv
SUBJECT
FIELD POINT OR DEPT. & BLDG. NO FIELD POINT OR DEPT. & BLDG NO.
D/5055
EXTRACTION TESTS ON VPK FILM
DATE YOUR LETTER
DATE THIS LETTER
2 July 1990
Attached is a copy of my report on the determination of nonvolatile extractives for our VPK film.
Also attached is a copy of a letter send to John Kay informing him of the test results and recomending a follow-up report of the final results by Goodyear.
S
Distribution: Sally Kline Joe Vyvoda Keith Gardner D'Lane Wisner Wally Bachtel
Z1641001
BFG-4956-NV 7/S6 LITHO IN U.S.A.
BFG15818