E & L Standards - Rubber Oligomers

E & L Standards

Cyclomethicone 7

CAT Number DCTI-C-4298
CAS Number 107-50-6
Molecular Formula C14H42O7Si7
Molecular Weight 519.08

2-Ethylhexyl Formate

CAT Number DCTI-C-4297
CAS Number 5460-45-7
Molecular Formula C9H18O2
Molecular Weight 158.24

3-Methylheptadecane

CAT Number DCTI-C-4292
CAS Number 6418-44-6
Molecular Formula C18H38
Molecular Weight 254.5

Diisobutyl Carbonate

CAT Number DCTI-C-4289
CAS Number 539-92-4
Molecular Formula C9H18O3
Molecular Weight 174.24

1,16-Dichlorohexadecane

CAT Number DCTI-C-4284
CAS Number 7735-39-9
Molecular Formula C16H32Cl2
Molecular Weight 295.33

Nonylcyclopropane

CAT Number DCTI-C-4283
CAS Number 74663-85-7
Molecular Formula C12H24
Molecular Weight 168.32

5-Methyloctadecane

CAT Number DCTI-C-4275
CAS Number 25117-35-5
Molecular Formula C19H40
Molecular Weight 268.53

1-Methyl-1-cyclododecene

CAT Number DCTI-C-4234
CAS Number 23070-53-3
Molecular Formula C13H24
Molecular Weight 180.34

2-Methylhexacosane

CAT Number DCTI-C-4281
CAS Number 1561-02-0
Molecular Formula C27H56
Molecular Weight 380.74

Eicosyl Ferulate

CAT Number DCTI-C-4293
CAS Number 64190-82-5
Molecular Formula C30H50O4
Molecular Weight 474.73

Dioctyl Methylphosphonate

CAT Number DCTI-C-4295
CAS Number 1832-68-4
Molecular Formula C17H37O3P
Molecular Weight 320.45

Triacontyl Acetate

CAT Number DCTI-C-4296
CAS Number 41755-58-2
Molecular Formula C32H64O2
Molecular Weight 480.86

2,4-Dimethylundecane

CAT Number DCTI-C-4273
CAS Number 17312-80-0
Molecular Formula C13H28
Molecular Weight 184.37

Octadecamethylcyclononasiloxane

CAT Number DCTI-C-4300
CAS Number 556-71-8
Molecular Formula C18H54O9Si9
Molecular Weight 667.39

8-Methylheptadecane

CAT Number DCTI-C-4301
CAS Number 13287-23-5
Molecular Formula C18H38
Molecular Weight 254.5

4,6-Dimethyldodecane

CAT Number DCTI-C-4279
CAS Number 61141-72-8
Molecular Formula C14H30
Molecular Weight 198.39

Ethylene Sebacate

CAT Number DCTI-C-4290
CAS Number 5578-82-5
Molecular Formula C12H20O4
Molecular Weight 228.29

8-Hexylpentadecane

CAT Number DCTI-C-4286
CAS Number 13475-75-7
Molecular Formula C21H44
Molecular Weight 296.58

Tris(2,4-di-tert-butylphenyl)phosphate

CAT NUMBER DCTI-C-4079
CAS NUMBER 95906-11-9
MOLECULAR FORMULA C42H63O4P
MOLECULAR WEIGHT 662.94

Hexadecamethylcyclooctasiloxane

CAT NUMBER DCTI-C-4049
CAS NUMBER 556-68-3
MOLECULAR FORMULA C16H48O8Si8
MOLECULAR WEIGHT 593.23

5,8,11,14,17,20-Hexaoxatetracosa-2,22-diyne-1,24-diol

CAT NUMBER DCTI-C-3918
CAS NUMBER 185378-84-1
MOLECULAR FORMULA C18H30O8
MOLECULAR WEIGHT 374.43

1-(3,5-di-tert-butyl-4-hydroxyphenyl)ethan-1-one

CAT NUMBER DCTI-C-3149
CAS NUMBER 14035-33-7
MOLECULAR FORMULA C16H24O2
MOLECULAR WEIGHT 248.37

Vinyl cinnamate

CAT NUMBER DCTI-C-3148
CAS NUMBER 17719-70-9
MOLECULAR FORMULA C11H10O2
MOLECULAR WEIGHT 174.2

4-t-Butyl-2-(1-methyl-2-nitroethyl)cyclohexanone

CAT NUMBER DCTI-C-3334
CAS NUMBER 1310686-07-7
MOLECULAR FORMULA C13H23NO3
MOLECULAR WEIGHT 241.33

(2E,4E)-2,4-Dodecadienoic acid

CAT NUMBER DCTI-C-3335
CAS NUMBER 24738-48-5
MOLECULAR FORMULA C12H20O2
MOLECULAR WEIGHT 196.29

7,9-di-tert-butyl-1-oxaspiro[4.5]deca-6,9-diene-2,8-dione

CAT NUMBER DCTI-C-3151
CAS NUMBER 82304-66-3
MOLECULAR FORMULA C17H24O3
MOLECULAR WEIGHT 276.38

3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid

CAT NUMBER DCTI-C-3150
CAS NUMBER 20170-32-5
MOLECULAR FORMULA C17H26O3
MOLECULAR WEIGHT 278.39

Rubber Oligomers

2,6,11-trimethyldodecane

CAT Number DCTI-C-4542
CAS Number 31295-56-4
Molecular Formula C15H32
Molecular Weight 212.42

Rubber oligomer -2

CAT NUMBER DCTI-C-3210
CAS NUMBER 63216-72-8
MOLECULAR FORMULA C13H23Cl
MOLECULAR WEIGHT 214.78

Rubber Oligomer 10

CAT NUMBER DCTI-C-3216
CAS NUMBER NA
MOLECULAR FORMULA C13H24O
MOLECULAR WEIGHT 196.33

Rubber Oligomer 6

CAT NUMBER DCTI-C-3214
CAS NUMBER 2514955-51-4
MOLECULAR FORMULA C13H23Br
MOLECULAR WEIGHT 259.23

Rubber oligomer -9

CAT NUMBER DCTI-C-3215
CAS NUMBER NA
MOLECULAR FORMULA C12H20O
MOLECULAR WEIGHT 180.29

Rubber oligomer – 8

CAT NUMBER DCTI-C-3147
CAS NUMBER 2234308-25-7
MOLECULAR FORMULA C12H20O2
MOLECULAR WEIGHT 196.29

Rubber Oligomer-1

CAT NUMBER DCTI-C-3199
CAS NUMBER 63251-38-7
MOLECULAR FORMULA C13H24
MOLECULAR WEIGHT 180.34

References

FAQ's

References

Dennis Jenke, Identification, analysis and safety assessment of leachables and extractables, TrAC Trends in Analytical Chemistry, Volume 101, April 2018, Pages 56-65 (https://doi.org/10.1016/j.trac.2017.10.024)
Richard Jähnke, Contamination of Injectable Powders by Volatile Hydrocarbons from Rubber Stoppers, Acta Pharmaceutica Technologica 36(3):139-148 (https://www.researchgate.net/publication/321197618_Contamination_of_Injectable_Powders_by_Volatile_Hydrocarbons_from_Rubber_Stoppers)

Frequently Asked Questions

What are “Extractables” and “Leachables”?

Extractables are chemical compounds extracted into solvents under forced conditions- during drug manufacturing and packaging. They can identify “leachables” that appear with contact with containers, rubber plungers of pre-filled syringes, etc.

What are the analytical methods to identify Rubber Oligomer impurities?

GC-MS, UHPLC-CAD, and headspace MS are the analytical methods to identify Rubber Oligomer impurities.

Why is it essential to remove Rubber Oligomer impurities from drug products?

Post-marketing product recalls are avoided by removing Rubber Oligomer impurities from drug products.

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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