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`Japanese pharmaceutical excipients d
`1996 / edited by the Japan Pharmaceutical E
`xcipients Conn
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`MYLAN INST. EXHIBIT 1080 PAGE 1
`
`
`
`Japanese Pharmaceutical Excipients Directory 1996 (JPED I996)
`ISBN4—8408—0418-4 C3047
`
`COPYRIGHT KC) 1996 by YAKUJI 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;
`
`MYLAN INST. EXHIBIT 1080 PAGE 1
`
`
`
`~.>:<ze'«éét-az~t>mfi*m
`
`Contents
`
`
`
`
`
`
`
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`
`ix
`
`i
`
`iii
`
`v
`
`1
`
`593
`
`615
`
`633
`
`i
`
`
`
`Recommendation Notice to Readers
`
`Foreword
`
`Preface
`
`JPED Monographs
`Official Japanese Pharmaceutical Excipients
`
`Appendix
`
`Non-Official Japanese Pharmaceutical Excipients
`
`Manufacturers’ Directory
`
`Index
`
`MYLAN INST. EXHIBIT 1080 PAGE 2
`
`MYLAN INST. EXHIBIT 1080 PAGE 2
`
`
`
`
`
`JPED Monographs
`
`437
`
`Propylene Glycol
`
`Code No.
`CAS No.
`
`002328
`57—55-6
`
`Chemical Name
`
`1,2-Propane diol
`
`Structural Formula
`
`OH
`I
`CH3CHCH20H
`
`Empirical Formula: Molecular Weight C3H302: 76.10
`
`Specific References
`
`JP XIII, JSFA VI, 118 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.
`
`Pharmacopoeia] Specifications Specific gravity dig: 1.038 — 1.041; Acid within limit;
`Chloride _<_0.007%; Sulfate $0.002%; Heavy metals 5 5 ppm; Arsenic 52 ppm; Glyce-
`rin within limit; Water 5 0.5% (2 g, direct titration); Residue an ignition 50.005% (20 g);
`Distilling range 184 - 189°C, 295 vol%.
`
`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.
`
`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.
`
`Trade Names (Maker) ADEKA Propylene Glycol (Asahi Denka Kogyo), (Asahi Glass).
`
`
`
`MYLAN INST. EXHIBIT 1080 PAGE 3
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`MYLAN INST. EXHIBIT 1080 PAGE 3
`
`
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