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Vista Chemical Company
900 Threadneedle Houston, Texas 77079 (713) 588-3000
OCC. ^; K t .Lie* . >1 H'lA
P.O.Box 19029 Houston, Texas 77224 Fax (713) 588-3236
February 23, 1990
. Drug Administration or Drugs and Biologi Document Room 12420 Parklawn Drive Room 2-14 Rockville, HD 20852 Attention: Allen Beadle
VIS1A
RE: DMF 6151
Dear Mr. Beadle:
Drug
Company polyvinyl chloride (PVC) resins. This modification adds
another resin type to Vista's
of P__V_C p^_r_o_d__u__c_t_s_. It also
establishes lower limits for several ingredients at 0.0%. The home
office address and reference authorization list has also been updated.
Should any questions arise in connection with this matter, please contact me directly. My phone number is (713)588-3
Sincerely,
. C. Ledvina Director, Environmental Activities
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DRUG MASTER FILE
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FOR
POLYVINYL CHLORIDE PRODUCTS
DMF 6151
January 31, 1990
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VAB.0001105256
Address List
Companies Authorized to Reference DMF Product Formulations and Technical Information 1. Vista PVC 5265 Resin 2. Vista PVC 5305 Resin 3. Vista PVC 5385 Resin 4. Vista PVC 5395 Resin 5. Vista PVC 5415 Resin 6. Vista PVC 5465 Resin
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ADDRESS LIST
1. Manufacturing Facility Addresses:
Vista Chemical Company Oklahoma City, Oklahoma
Vista Chemical Company Aberdeen, Mississippi
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2. Address Correspondence To:
Joseph C. Ledvina Vista Chemical Company 900 Threadneedle Houston, Texas 77079
3. Home Address:
Vista Chemical Company 900 Threadneedle Houston, Texas 77079
4. Name and Title of Individual Addresses:
Joseph C. Ledvina Director of Environmental Activities
5. Holder of Drug Master File:
Vista Chemical Company
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REFERENCE AUTHORIZATION
The following persons are authorized by Vista Chemical Company to refer the Food and Drug Administration to this Drug Master File in conjunction with the review of new drug applications or other FDA drug approval processes.
1. American Mirrex 2. Klockner-Pentaplast of America, Inc. 3. Nibco
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Ledrlna * rector of Environmental Activities
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VISTA PVC 5265 RESIN Confidential Product Formulation
1. Polyvinyl chloride homopolymer
2. Glycerol Monostearate (21 C.F.R. 182.1324) OR
Calcium Stearate (21 C.F.R. 184.1229)
3. Butylated hydroxytoluene (21 C.F.R. 181.24)
99.84 to 99.97% 0.00 to 0.1% 0.0 to 0.5% 0.0 to 0.15%
OR
ISONOX 132 at least:
0.0 to 0.18%
95% 2,6,-di-tert-butyl 4-secondary butyl phenol 1-2% 2,4,6,tri-tertbutyl phenol
1-2% 2,4, dl-tert butyl 6-secondary butyl phenol 1-2% di-butyl phenol
[See attached reference 1]
Description
Vista 5265 PVC resin is a general purpose, low molecular weight PVC homopolymer for use primarily in injection molding processes where low melt viscosity and good physical properties are required.
Applications
Vista 5265 PVC resin is designed to provide an optimum balance between ease of processing and excellent physical properties. It can be used to replace general purpose PVC resin of higher molecular weight to increase productivity and gain processing latitude with minimal reduction of physical properties.
The low melt viscosity of Vista 5265 PVC resin makes it ideally suited for injection molding applications, The molecular weight is such that it can be used to formulate Type I and Type II rigid inj ection molding compounds. Eliminating the costly pelletizing step and the associated heat history results in a less, expensive, more consistent product.
The excellent heat stability and low melt viscosity of Vista 5265 PVC resin has resulted in wide acceptance for rigid and cellular profile extrusion and vacuum formable sheeting.
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Properties
ASTM D 1755 Classification
Specific Viscosity (0.4 g in 100 ml Nitrobenzene at 25* C)
Inherent Viscosity ASTM D 1234-66T (Method A)
Bulk Density (g/cc) (lb/cufcj
Volatiles t %
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Typical
GP-1-16000
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0.68
0.55 34.3
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VISTA PVC 5305 RESIN Confidential Product Formulation
1. Polyvinyl chloride homopolymer
99.84 to 99.979%
2. Glycerol Monostearate (21 C.F.R. 182.132) OR
Calcium Stearate (21 C.F.R. 184.1229)
0.00 to 0.1% 0.0 to 0.05%
3. Butylated hydroxytoluene (21 C.F.R. 181.24)
0.0 to 0.15%
OR
IS0N0X 132
0.01 to 0.18%
at least:
95% 2,6,-di-tert-butyl 4-secondary butyl phenol
1-2% 2,4,6,trl-tertbutyl phenol
1-2% 2,4, dl-tert butyl 6-secondary butyl phenol
1-2% di-butyl phenol
[See attached reference 1]
Description
Vista 5305 PVC resin Is a general purpose, low molecular weight PVC homopolymer for use in calendering, extrusion and injection molding processes where low melt viscosity and good physical properties are required.
Applications
Vista 5305 PVC resin is designed to provide an optimum balance between ease of processing and excellent physical properties. It can be used to replace general purpose PVC resin of higher molecular weight to Increase productivity and gain processing latitude with minimal reduction of physical properties.
The low melt viscosity of Vista 5305 PVC resin makes it ideally suited for injection molding applications. The molecular weight is such that it can be used to formulate Type I and Type II rigid injection molding compounds with minimum quantities of expensive processing aids and impact modifiers. This eliminates the dusting problems traditionally associated with these micro ingredients, thereby allowing the use of dryblends. Eliminating the costly pelletizing step and the associated heat history results in a less expensive, more consistent product.
The excellent heat stability and low melt viscosity of Vista 5305 PVC resin has resulted in wide acceptance for rigid and cellular profile extrusion. In some instances, it can be compounded into an acceptable replacement for more expensive copolymer formulations.
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Properties
ASTM D 1755 Classification
Specific Viscosity (0.4 g in 100
Nitrobenzene at 25
Inherent Viscosity ASTM D 1243-66T (Method A)
Bulk Density (g/cc) (lb/cu ft)
Volatiles, %
Particle Size % on 40 Mesh % through 200 Mesh
Typical GP-2-16000
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0.74
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VISTA PVC 5385 RESIN Confidential Product Formulation
1. Polyvinyl chloride homopolymer
.2 Calcium Stearate
(21 C.F.R. 184.1229)
3. Butylated hydroxytoluene (21 C.F.R. 181.24)
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99.835 to 99.989% 0.0 to 0.5% 0.0 to 0.15%
ISONOX 132 at least:
0.0 to 0.18%
95% 2,6,-di-tert-butyl 4-secondary butyl phenol 1-2% 2,4,6,tri-tertbutyl phenol
1-2% 2,4, di-tert butyl 6-secondary butyl phenol 1-2% di-butyl phenol
[See attached reference 1]
Description
5385 PVC resin can be used In either extrusion, calendering or injection molding processes for rigid and flexible products.
App 1 icat ions
Vista 5385 PVC resin is a versatile resin that can be used for many diverse rigid and flexible applications.
Its excellent heat stability, consistency and processing characteristics are ideal for rigid applications such as PVC pipe, siding and other profiles. These properties allow the production of high quality end products at high production rates.
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The low gel content, uniform absorption of plasticizer, and high clarity make Vista 5385 resin an ideal choice for flexible applications involving calendering, extrusion or Injection molding.
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VISTA PVC 5395 RESIN Confidential Product Formulation
1 Polyvinyl chloride homopolymer
2 Calcium Stearate
(21 C.F.R. 184.1229)
3 Butylated hydroxytoluene (21 C.F.R. 181.24)
OR
99.835 to 99.989% 0.0 to 0.5% 0.0 to 0.15%
ISONOX 132 at least
0.0 to 0.18%
95% 2.6,-di-tert-butyl 4-secondary butyl phenol
1-2% 2.4.6,tri-tertbutyl phenol
1-2% 2,4, di-tert butyl 6-secondary butyl phenol
1-2% di-butyl phenol
[ attached reference 1]
Description
Vista 5395 PVC resin can be used in either extrusion,
or injection molding market for fl y1V>i
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film
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Applications
Vista 5395 PVC resin Is a versatile resin that can be used for mam
diverse rigid and flexible applications.
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Its excellent heat stability, consistency and processing characteristics allow the production of high quality end products at high production
The low gel content, uniform absorption of plasticizer, and high clarity make Vista 5395 resin an ideal choice for flexible orPblom1fUxible1filn.Calendering' extrusin- injection molding
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Properties
ASTM D 1755 Classification
Specific Viscosity (0.4 g in 100 ml Nitrobenzene at 25* C)
Inherent Viscosity ASTM D 1243-58T (Method A)
Bulk Density (g/cc) (Ib/cu ft)
Volatiles, %
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0.92
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VISTA PVC 5415 RESIN Confidential Product Formulation
1. Polyvinyl chloride homopolymer
.2 Calcium Stearate
(21 C.F.R. 184.1229)
3. Butylated hydroxytoluene (21 C.F.R. 181.24)
99.82 to 99.989% 0.0 to 0.5% 0.0 to 0.15%
Description
Vista 5415 PVC resin is a general purpose PVC homopolymer which can be used in either extrusion, calendering or injection molding processes for rigid and flexible products.
Appllestions
The uniform absorption of high levels of plasticizer, low gel content, high clarity and excellent heat stability of formulations based on Vista 5415 resin allow it to be used in many diverse applications.
The relatively high molecular weight of Vista 5415 PVC resin makes ^ particularly suitable for flexible applications requiring good physical properties and their retention on aging.
The combination of optimum physical properti the use of plasticized dryblend formulation
Properties
ASTM D 1755 Classification
Specific Viscosity (0.4 g in 100 ml Nitrobenzene at 25* C)
Inherent Viscosity ASTM D 1243-66T (Method A)
Bulk Density (g/cc) (lb/cu ft)
Volatiles, %
Particle Size
% on 40 Mesh
% through 200 Mesh
Typical GP-5-15300
0.42
1.02
0.50 32 0.3
nil <5.0
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VISTA PVC 5465 RESIN Confidential Product Formulation
1. Polyvinyl chloride homopolymer
2. Calcium Stearate (21 C.F.R. 184.1229)
3. fiutylated hydroxytoluene (21 C.F.R. 181.24)
99.82 to 99.989% 0.0 to 0.5% 0.0 to 0.15%
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Description
hnlm.15465
r*?ln is * B#n*r*1 purpose high molecular weight
the developoent of maximum physical properties is desired. The
he^$^ti"corfittK i*" ** ?al,,'1*ly d**18n,d to produce a PVC resin
* orYac* balatvca f properties. Its molecular weight is
blj t0 ?iv* th* quallty of "toughness" to the finished
tide while the melt viscosity is sufficiently low to allow for ease or manufacture.
Applications
Vista 5465 PVC resin is particularly suitable for use in flexible
applications where the development properties are desired.
and
retention
of
maximum
physical
The unifon. absorption of high levels of plasticizer, low ,,
weightC 'of^yista**5465 ""lle"e heaCu lCabillcy high molecul.
weight of Vista 5465 allow it to be used in many diverse an demanding applications. They include calenderine. inlectfnn mni
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