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`FRSAID : 8320659
`PIAA : 2020/10/8
`Al FAAID : £13380443
`FFABS, : Kacie Nev KR
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`REE :SD41-AD
`HAW:
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`Japanese pharmaceutical excipients directory
`1996 / edited by the Japan Pharmaceutical E
`xcipients Coun
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`Photoduptication Service Division (TOKYO)
`National. Diet Library, Japan
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`MYLANINST. EXHIBIT 1080 PAGE1
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`Email: mecopy@ndl. go, JP
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`Japanese Pharmaceutical Excipients Directory 1996 (JPED 1996)
`ISBN4-8408-0418-4 C3047
`COPYRIGHT ©1996 by YAKUJH] NIPPO, LTD.
`
`None of the content of this publication may be reproduced by any means
`without the prior written permission of the publisher YAKUJI NIPPO, LTD.,
`1, Kanda Izumicho, Chiyoda-ku, Tokyo, 101 Japan; Tel: +81-3-3862-2141,
`_
`Lone ene Awe
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`MYLAN INST. EXHIBIT 1080 PAGE 1
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`
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`PSRs
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`Contents
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`SELESRENeREILESABINRHRITESEROR
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`PRETALLRPS
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`ETERS
`BLOMLESRRBOERANNYTRLPPOPOS)
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`TLETERRELO
`TRAST
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`Recommendation Notice to Readers
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`Foreword
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`Preface
`
`JPED Monographs
`Official Japanese Pharmaceutical Excipients
`
`Appendix
`Non-Official Japanese Pharmaceutical Excipients
`
`Manufacturers’ Directory
`
`Index
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`i
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`ili
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`V
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`]
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`593
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`615
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`633
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`MYLANINST. EXHIBIT 1080 PAGE 2
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`MYLAN INST. EXHIBIT 1080 PAGE 2
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`JPED Monographs
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`437
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`Propylene Glycol
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`Code No.
`CAS No.
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`002328
`57-55-6
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`Chemical Name
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`1,2-Propanediol
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`Structural Formula
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`OH
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`CH3CHCH2OH
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`Empirical Formula: Molecular Weight C;H,O,: 76.10
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`Specific References
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`JP XIII, JSFA VI, JIS K 8837, Special class.
`
`Properties Clear, colorless, viscous liquid. Odorless, and has a slightly bitter taste.
`Miscible with water, with methanol, with ethanol and with pyridine. Freely soluble in
`ether. Hygroscopic.
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`Pharmacopoeial Specifications Specific gravity d3}: 1.038 — 1.041; Acid within limit;
`Chloride <0.007%; Sulfate =0.002%; Heavy metals <5 ppm; Arsenic <2 ppm; Glyce-
`rin within limit; Water <0.5% (2 g,direct titration); Residue on ignition <0.005% (20 g);
`Distilling range 184 - 189°C, =95 vol%.
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`Containers Tight containers
`
`isotonicity,
`Uses Base, binder, coating agent, dispersing agent, emulsifying agent,
`plasticizer, preservative, softening agent, solubilizer, solubilizing agent, solvent, soothing
`agent, stabilizer, suspending agent, tackifier, tackining agent, thickening agent, vehicle,
`wetting agent, wetting regulator.
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`Administration Route Oral administration, intravenous injection, intramuscular injec-
`tion, subcutaneous injection, general external preparation, sublingual application,
`rectum vagina urethra application, ophthalmic preparation, otorhinology preparation,
`dental external use and troche use, other external use, insecticide.
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`Trade Names (Maker) ADEKA Propylene Glycol (Asahi Denka Kogyo), (Asahi Glass).
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`MYLANINST. EXHIBIT 1080 PAGE3
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`MYLAN INST. EXHIBIT 1080 PAGE 3
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