-
1
-
-
0242326312
-
Guideline for Submitting Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
-
"Guideline for Submitting Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products," Federal Register 58 (231), 63996-64001 (1993).
-
(1993)
Federal Register
, vol.58
, Issue.231
, pp. 63996-64001
-
-
-
2
-
-
0003577283
-
-
part 211.65 (US Government Printing Office, Washington, DC).
-
Title 21, Code of Federal Regulations, part 211.65 (US Government Printing Office, Washington, DC).
-
Code of Federal Regulations
-
-
-
3
-
-
0011224487
-
Biological Reactivity Tests, in Vivo
-
United States Pharmacopeial Convention, Rockville, MD
-
"Biological Reactivity Tests, In Vivo," in United States Pharmacopeia 23 (88) (United States Pharmacopeial Convention, Rockville, MD, 1995), p. 1699.
-
(1995)
United States Pharmacopeia
, vol.23
, Issue.88
, pp. 1699
-
-
-
4
-
-
0003577283
-
-
parts 170-199, US Government Printing Office, Washington, DC
-
Title 21, Code of Federal Regulations, parts 170-199, (US Government Printing Office, Washington, DC).
-
Code of Federal Regulations
-
-
-
5
-
-
33745539721
-
Elastomeric Closures for Injections
-
United States Pharmacopeial Convention, Rockville, MD
-
"Elastomeric Closures for Injections," in United States Pharmacopeia 23 〈381〉 (United States Pharmacopeial Convention, Rockville, MD, 1995), p. 1736.
-
(1995)
United States Pharmacopeia
, vol.23
, Issue.381
, pp. 1736
-
-
-
6
-
-
0003280366
-
Containers - Polyethylene Terephthalate Bottles and Polyethylene Terephthalate G Bottles
-
United States Pharmacopeial Convention, Rockville, MD
-
"Containers - Polyethylene Terephthalate Bottles and Polyethylene Terephthalate G Bottles," in United States Pharmacopeia 23 〈661〉 (United States Pharmacopeial Convention, Rockville, MD, 1995), p. 1784.
-
(1995)
United States Pharmacopeia
, vol.23
, Issue.661
, pp. 1784
-
-
-
7
-
-
2642590476
-
Extractables from Elastomeric Closures: Analytical Procedures for Functional Group Characterization/Identification
-
Parenteral Drug Association
-
"Extractables from Elastomeric Closures: Analytical Procedures for Functional Group Characterization/Identification," Technical Methods Bulletin No. 1, Parenteral Drug Association (1980).
-
(1980)
Technical Methods Bulletin No. 1
, vol.1
-
-
-
9
-
-
0003091595
-
The Model Stream Approach: Defining the Worst-Case Conditions
-
T.E. Stone et al., "The Model Stream Approach: Defining the Worst-Case Conditions," Pharm. Technol. 20 (2), 34-51 (1996).
-
(1996)
Pharm. Technol.
, vol.20
, Issue.2
, pp. 34-51
-
-
Stone, T.E.1
-
13
-
-
0001309764
-
Classification of the Solvent Properties of Common Liquids
-
L.R. Snyder, "Classification of the Solvent Properties of Common Liquids" J. Chromatog. 92, 223-230 (1974).
-
(1974)
J. Chromatog.
, vol.92
, pp. 223-230
-
-
Snyder, L.R.1
-
14
-
-
0017982611
-
Classification of the Solvent Properties of Common Liquids
-
L.R. Snyder, "Classification of the Solvent Properties of Common Liquids" J. Chromatog. Sci. 6, 223-234 (1978).
-
(1978)
J. Chromatog. Sci.
, vol.6
, pp. 223-234
-
-
Snyder, L.R.1
-
15
-
-
0025945102
-
Additive Model for the Evaluation of Interactions between Aqueous Solutes and Multi-Component Container Materials
-
D.R. Jencke, "Additive Model for the Evaluation of Interactions Between Aqueous Solutes and Multi-Component Container Materials," J. Paren. Sci. Technol. 45, 233-238 (1991).
-
(1991)
J. Paren. Sci. Technol.
, vol.45
, pp. 233-238
-
-
Jencke, D.R.1
-
16
-
-
0027240023
-
Accumulation Model for Solutes Leaching from Polymeric Containers
-
D.R. Jencke et al., "Accumulation Model for Solutes Leaching from Polymeric Containers," J. Paren. Sci. Technol. 47, 172-176 (1993).
-
(1993)
J. Paren. Sci. Technol.
, vol.47
, pp. 172-176
-
-
Jencke, D.R.1
-
17
-
-
0028287474
-
Determination of Solute-Polymer Interaction Properties Via Two-Stage Extraction
-
D.R. Jencke, "Determination of Solute-Polymer Interaction Properties Via Two-Stage Extraction," Pharm. Res. 11 (5), 774-775 (1994).
-
(1994)
Pharm. Res.
, vol.11
, Issue.5
, pp. 774-775
-
-
Jencke, D.R.1
-
18
-
-
0026320077
-
Directly Coupled Supercritical-Fluid Extraction Capillary Supercritical-Fluid Chromatography of Polymer Additives
-
H. Daimon and Y. Hirata, "Directly Coupled Supercritical-Fluid Extraction Capillary Supercritical-Fluid Chromatography of Polymer Additives," Chromatographia 32, 549-554 (1991).
-
(1991)
Chromatographia
, vol.32
, pp. 549-554
-
-
Daimon, H.1
Hirata, Y.2
-
19
-
-
0025053747
-
Influence of Solute Degradation on the Accumulation of Solutes Migrating into Solution from Polymeric Containers
-
L.A. Cruz et al., "Influence of Solute Degradation on the Accumulation of Solutes Migrating into Solution from Polymeric Containers," Pharm. Res. 7, 967-972 (1990).
-
(1990)
Pharm. Res.
, vol.7
, pp. 967-972
-
-
Cruz, L.A.1
-
20
-
-
0003092464
-
Methodology for Analysis of Filter Extractables: A Model Stream Approach
-
T. Stone, V. Goel, and J. Leszcak, "Methodology for Analysis of Filter Extractables: A Model Stream Approach," Pharm. Technol. 18 (10), 116-130 (1994).
-
(1994)
Pharm. Technol.
, vol.18
, Issue.10
, pp. 116-130
-
-
Stone, T.1
Goel, V.2
Leszcak, J.3
-
21
-
-
0000426855
-
Liquid Chromatographic Determination of Residual Reactants and Reaction By-Products in Polyethylene Terephthalate
-
T. Begley and H.C. Hollifield, "Liquid Chromatographic Determination of Residual Reactants and Reaction By-Products in Polyethylene Terephthalate," JAOAC 72, 468-470 (1989).
-
(1989)
JAOAC
, vol.72
, pp. 468-470
-
-
Begley, T.1
Hollifield, H.C.2
-
22
-
-
84982386467
-
Cyclische Oligomere in Polyestern aus Diolen und Aromatische Dicarbonsauren
-
G. Wick and H. Zeitler, "Cyclische Oligomere in Polyestern aus Diolen und Aromatische Dicarbonsauren," Die Angewandte Makromolekulare Chemie 112, 59-94 (1983).
-
(1983)
Die Angewandte Makromolekulare Chemie
, vol.112
, pp. 59-94
-
-
Wick, G.1
Zeitler, H.2
-
23
-
-
0008586581
-
HPLC Analysis of Cyclooligoamides 6 and 66
-
C. Guaita, "HPLC Analysis of Cyclooligoamides 6 and 66," Makromol. Chem. 185, 459-465 (1984).
-
(1984)
Makromol. Chem.
, vol.185
, pp. 459-465
-
-
Guaita, C.1
-
24
-
-
0027515968
-
Determination of Phenolic Antioxidants in Pharmaceutical Formulations by Liquid Chromatography and Migration Study on HOPE Packagings
-
N. Yagoubi et al., "Determination of Phenolic Antioxidants in Pharmaceutical Formulations by Liquid Chromatography and Migration Study on HOPE Packagings," Chromatographia 35, 455-458 (1993).
-
(1993)
Chromatographia
, vol.35
, pp. 455-458
-
-
Yagoubi, N.1
-
26
-
-
33745532798
-
-
Pall Ultrafine Filtration Company, East Hills, NY
-
66 Posidyne Filter Cartridges," Pall Ultrafine Filtration Company, East Hills, NY, 1995.
-
(1995)
66 Posidyne Filter Cartridges
-
-
-
27
-
-
33745535571
-
-
66, and Posidyne are registered trademarks of Pall Corp.
-
66, and Posidyne are registered trademarks of Pall Corp.).
-
(1980)
66 Posidyne Membrane Cartridges
-
-
-
28
-
-
0000507113
-
Solvent Characterization by Gas-Liquid Partition Coefficients of Selected Solutes
-
L. Rohrsneider, "Solvent Characterization by Gas-Liquid Partition Coefficients of Selected Solutes," Anal. Chem. 45, 1241-1247 (1973).
-
(1973)
Anal. Chem.
, vol.45
, pp. 1241-1247
-
-
Rohrsneider, L.1
-
29
-
-
0030511839
-
Analysis and Evaluation of Filter Cartridge Extractables for Validation in Pharmaceutical Downstream Processing
-
O.W. Reif, P. Sölkner, and J. Rupp, "Analysis and Evaluation of Filter Cartridge Extractables for Validation in Pharmaceutical Downstream Processing," J. Pharm. Sci. Technol. 50 (6), 399-410 (1996).
-
(1996)
J. Pharm. Sci. Technol.
, vol.50
, Issue.6
, pp. 399-410
-
-
Reif, O.W.1
Sölkner, P.2
Rupp, J.3
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