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`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 1/22
`
`(cid:127)
`(cid:127)
`

`

`jpxni
`
`THE JAPANESE PHARMACOPOEIA
`THIRTEENTH EDITION
`
`Under the supervision of the Research and Development Division,
`Pharmaceutical Affairs Bureau, Ministry of Health and Welfare
`
`Official from April 1, 1996
`
`COVINGTON & BURLING
`food & DRUG LAW
`library
`
`THE SOCIETY OF JAPANESE PHARMACOPOEIA
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 2/22
`
`

`

`I-
`
`.
`
`.1.
`
`THE SOCIETY OF JAPANESE PHARMACOPOEIA
`
`Published 1996 by
`
`2-12-15, Shibuya, Shibuya-ku, Tokyo, 150 JAPAN
`Tel: 81-3-3400-5634; Fax: 81-3-3400-3158
`
`Distributed by
`YAKUJI NIPPO, LTD.
`1, Kanda Izumicho, Chiyoda-ku, Tokyo, 101 JAPAN
`
`Notice: This English Version of the Japanese Pharmacopoeia, Thir
`teenth Edition, is published to meet the needs of the non-Japanese speak
`ing people. When and if any discrepancy arises between the Japanese
`original and its English translation, the former is authentic.
`
`ISBN4-8408-0389-7 C3047
`
`Printed in Japan
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 3/22
`
`

`

`Mylan v. Qualicaps, |PR2017—OO203
`_AL|q;APS EX. 2016 — 4/22
`-4i-
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 4/22
`
`

`

`The Ministry of Health and Welfare
`Notification No. 73
`
`In accordance withthe provision of Article 41 of the Pharmaceutical Affairs Law
`(Law No. 145,1960), we establish the Japanese Pharmacopoeia (hereinafter referred
`to as the "new Pharmacopoeia") as follows*, and will apply it from April 1, 1996.
`The Japanese Pharmacopoeia prescribed by the Ministry of Health and Welfare
`Notification No. 51 dated March 1991 according to the Law (hereinafter referred to
`as the "previous Pharmacopoeia") shall be abrogated on March 31, 1996. In this
`case, the drugs included in the previous Pharmacopoeia which have been approved
`before or on April 1,1996, in accordance with the provision of Article 14of the Law
`(inclusive of application mutatis mutandis inArticle 23; the same hereinafter) [inclu
`sive of drugs (hereinafter referred to as "drugs notrequiring approval") designated
`as those not requiring approval to manufacture or import on March 31, 1996, in ac
`cordance with the Ministry of Health and Welfare Notification No. 104 issued in
`March 1994 (matters related to designation of drugs not requiring approval to
`manufacture or import in accordance with Paragraph 1 of Article 14 of the Phar
`maceutical Affairs Law)], even though not admitted to the new Pharmacopoeia,
`shall be recognized to be included in the new Pharmacopoeia up to September 30,
`1997, and the standards for the previous Pharmacopoeia [limited to those for such
`drugs] shall berecognized to conform to those for the new Pharmacopoeia. The ti
`tles and/or standards for drugs in the previous Pharmacopoeia, even though
`changed in the new Pharmacopoeia, shall be recognized as those in the new Phar
`macopoeia up to September 30, 1997. The drugs admitted to the new Phar
`macopoeia (except for those included in the previous Pharmacopoeia) which have
`been approved before or on April 1, 1996, (inclusive of those not requiring approv
`al) in accordance with theprovision of Article 14 of the Law shall berecognized not
`to be included in the new Pharmacopoeia up to September 30, 1997.
`
`Naoto Kan
`Minister of Health and Welfare
`
`March 13, 1996
`
`v.
`
`•The word"follows" heremdicates the contentsof Part I and Part II in the JapanesePharmacopoeia,
`Thirteenth Edition (pp. 1—1064).
`
`Mylan v. Qualicaps, IPR2017-00203
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`
`

`

`Mylan v. Qualicaps, lPR20.17-—_O_(‘)2('_)3 —
`Q ALICAPS EX; 2016.4 6/22
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 6/22
`
`

`

`CONTENTS
`
`Preface
`The Japanese Pharmacopoeia, Thirteenth
`Edition, Part I
`General Notices
`General Rules for Preparations
`General Tests, Processes and Apparatus
`1. Absorbance Ratio Method
`2. Alcohol Number Determination
`3. Ammonium Limit Test
`
`i
`
`1-712
`1
`5
`15
`15
`16
`17
`
`24
`24
`25
`25
`25
`
`17
`4. Arsenic Limit Test
`5. Atomic Absorption Spectrophotometry... 19
`6. Bacterial Endotoxins Test
`20
`7. Boiling Point and Distilling Range
`Test
`8. Chloride Limit Test
`9. Congealing Point Determination
`10. Content Uniformity Test
`11. Crude Drugs Test
`12. Determination of Specific Gravity
`and Density
`13. Digestion Test
`14. Disintegration Test
`15. Dissolution Test
`16. Electrometric Titration Method
`17. Fats and Fatty Oils Test
`18. Flame Coloration Test
`19. Fluorometry
`20. Gas Chromatography
`21. Heavy Metals Limit Test
`22. Infrared Spectrophotometry
`23. Iron Limit Test
`24. Liquid Chromatography
`25. Loss on Drying Test
`26. Loss on Ignition Test
`27. Melting Point Determination
`28. Methanol Test
`29. Methoxyl Assay
`30. Microbial Limit Test
`
`27
`29
`32
`33
`36
`38
`40
`40
`40
`42
`43
`44
`45
`47
`47
`48
`49
`49
`49
`
`73
`75
`76
`82
`82
`85
`86
`
`87
`89
`90
`92
`92
`
`55
`
`55
`
`72
`
`72
`
`31. Mineral Oil Test
`32. Nitrogen Determination
`(Semimicro Kjeldahl Method)
`33. Nuclear Magnetic Resonance
`55
`Spectroscopy (^H)
`57
`34. Optical Rotation Determination
`57
`35. Osmolarity Determination
`58
`36. Oxygen Flask Combustion Method
`59
`37. Paper Chromatography
`go
`38. pH Determination
`61
`39. Pyrogen Test
`51
`40. Qualitative Tests
`41. Readily Carbonizable Substances Test.... 67
`42. Refractive Index Determination
`67
`43. Residue on Ignition Test
`67
`44. Spectrophotometry
`gg
`45. Sterility Test
`46. Sulfate Limit Test
`47. Test for Acid-neutralizing Capacity
`of Gastrointestinal Medicines
`48. Test for Glass Containers
`for Injections
`49. Test for Rubber Closure for Aqueous
`Infusions
`50. Test for Total Organic Carbon
`51. Test Methods for Plastic Containers
`52. Thin-layer Chromatography
`53. Viscosity Determination....
`54. Vitamin A Assay
`55. Volatile Contaminants in Ethanol
`56. Water Determination
`(Karl Fischer Method)
`57. Weight Variaton Test
`58. X-Ray Powder Diffraction Method
`59. (1) Reference Standards
`(2) Reagents, Test Solutions
`(3) Standard Solutions for Volumetric
`Analysis
`
`Mylan v. Qualicaps, IPR2017-00203
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`
`

`

`Contents
`
`(4) Standard Solutions
`(5) Matching Fluids for Color
`(6) Optical Filters for Wavelength and
`Transmission Rate Calibration
`(7) Measuring Instruments,
`Appliances
`60. (1) Sterilization and Aseptic
`.
`Manipulation
`(2) Reverse Osmosis-Ultrafiltration
`Official Monographs
`
`177
`
`178
`
`17Q
`^
`
`1R1
`
`182
`
`The Japanese Pharmacopoeia, Thirteenth
`Edition, Part
`General Notices
`General Rules for Crude Drugs
`General Rules for Preparations
`
`713-938
`713
`'
`713
`714
`
`JP XIII
`
`General Tests, Processes and Apparatus
`Official Monographs
`
`714
`715
`
`Infrared Reference Spectra
`Part 1
`Part II
`
`939-1064
`940
`
`General Information
`1. Media Fill Test
`2. Plastic Containers for Pharmaceutical
`Products
`3. Preservatives-Effectiveness Tests
`4. Validation of Analytical Procedures
`
`Index
`Index Nominum
`
`1065
`
`1069
`1071
`
`1075
`10^^
`
`Mylan v. Qualicaps, IPR2017-00203
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`
`

`

`PREFACE
`
`On June 12,1991, just after the promulgation of the'
`Twelfth Edition of the Pharmacopoeia of Japan on
`March 25,1991 (by Notification No. 51 of the Ministry
`of Health and Welfare), the Minister for Health and
`Welfare, in compliance with the provisions of Para
`graph 3 of Article 41 of the Pharmaceutical Affairs
`Law (Law No. 145,1960), consulted the Central Phar
`maceutical Affaks Council (CPAC) about the revision
`of the book for the next edition. That was because the
`Japanese Pharmacopoeia (JP) is required to keep pace
`with progress in medical and pharmaceutical sciences.
`In July and October 1991, the Council, at meetings of
`the Committee on JP, established the principles for the
`preparation of the JP Thirteenth Edition, setting out
`the characteristics and roles of JP, standards for the
`selection of articles, the items and date of the revision,
`and the organization of the Subcommittee on JP, as
`well as agreeing on the publication, if necessary, of a
`supplement to the ciurrent JP Twelfth Edition.
`At the above meeting, the following "five pillars"
`were established as the basic principles of the JP Thir
`teenth Edition: 1) making it more substantial by includ
`ing all drugs which are important from the viewpoint
`of health care and medical treatment, 2) improving the
`quality of analytical tests and reducing test items by
`positively introducing tests using instrumental tech
`niques, 3) ensuringtransparency regardingthe revision
`of the JP by opening its draft to the public, 4) taking
`into consideration its compatibility with equivalent
`publications in the rest of the world and 5) setting up a
`scheme for furnishing information regarding the JP,
`including information on drugs.
`It was agreed that the JP should have the characteris
`tics of an official standard for the description and
`quality of drugs which are generally recognized to be
`medically significant from the viewpoint of medical
`treatment, that its role should be to specify the quality
`standards not only of drugs which are filed in it, but
`also of all drugs in principle, as well as tests, and that
`at the same time, it should help to ensure compatibility
`regarding quality of drugs with the rest of the world.
`It was also agreed that JP articles should cover drugs
`which are important from the viewpoint of health care
`and medical treatment based on demand, frequency of
`use and clinical results, and which meet the established
`standards as regards their description and quality, that
`especially, drugs whose review has been finished or is
`to be finished before the JP Thirteenth Edition is im
`plemented be filed in it in principle, except those which
`are not widely used, that opinions from medical treat-
`ment-related groups be referred to in selecting articles
`as occasion may demand, and that the completion of
`the JP Thirteenth Edition be slated for April 1996.
`
`Under the Subcommittee on JP, the following nine
`panels were established: Panel on the Principles of Re
`visions; Panel on the Selection of Articles; First Panel
`on Medicinal Chemicals; Second Panel on Medicinal
`Chemicals; Panel on General Tests; Panel on Prepara
`tions; Panel on Crude Drugs; Panel on Nomenclature;
`Panel on Excipients. Later, in November 1994, the
`Committee on JP established two new panels. Panel
`on Material Sciences and Panel on Biological Drugs.
`It was decided that the JP will be revised not only ev
`ery five years, in line with the revision policy of the JP
`Eleventh Edition, but also more frequently, if necessa
`ry to take account of recent progress of science and in
`the interests of international harmonization.
`In accordance with the revision principles, the eleven
`panels at once started discussion of such subjects as
`selection of articles, general notices, general rules for
`preparations, gener^ tests, and monographs ondrugs.
`Draft revisions covering subjects in the general no
`tices, the general rules for preparations, the general
`tests, and monographs on drugs, for which discussions
`were finished between April 1991, after completion of
`the JP Twelfth Edition, and July 1993, were prepared
`for a supplement to the book. They were examined by
`the Committee on JP in July 1993, followed by the Ex
`ecutive Committee of CPAC, and then submitted to
`the Minister of Health and Welfare in September of
`the same year. The Supplement (Supplement I) was
`promulgated on October 1, 1993 (by Notification No.
`215 of the Ministry of Heailth and Welfare).
`The Panels had met as follows to prepare Supple
`ment drafts: Panel on the Principles of Revisions,
`twice; First Panel on Medicinal Chemicals, 20 times;
`Second Panel on Medicinal Chemicals, 11 times; Panel
`on General Tests, 14 times; Panel on Preparations, 12
`times; Panel on Nomenclature, 8 times; Panel on
`Crude Drugs, 5 times; Panel on the Selection of Arti
`cles, twice.
`In consequence of this revision, the JP Twelfth Edi
`tion with Supplement I carries 781 articles in Part I, of
`which 750 articles have been brought forward from
`Part I of the JP XII main volume, and 31 articles have
`been newly admitted; and 471 articles in Part II, all of
`which have been brought forward from Part II of the
`JP XII main volume.
`It should be noted that in the preparation of the
`drafts of the revised edition, generous cooperation was
`given by the Technical Committee of the Pharmaceuti
`cal Manufacturer's Association of Tokyo and of Osa
`ka, the Crude Drugs Association of Tokyo, the Federa
`tion of Crude Drugs Associations of Japan, the Japan
`Flavor and Fragrance Manufacturer's Association, the
`Japan Pharmaceutical Manufacturer's Association,
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 9/22
`
`

`

`ii
`
`Preface
`
`the Japanese Society of Hospital Pharmacists, the
`Japan Pharmaceutical Association, and the Japan Oil
`seed Processors Association.
`The revision work was continued in the Subcommit
`tee on JP. The general notices, the general rules for
`preparations, the general tests, and monographs on
`drugs, for which discussions were completed between
`July 1993, just after execution of Supplement I of the
`JP Twelfth Edition, and September 1994, were com
`bined in a further supplement to the book. The drafts
`were examined by the Committee on JP in November
`1994, followed by the Executive Committeeof CPAC,
`and then submitted to the Minister of Health and Wel
`fare in December of the same year as Supplement II of
`the JP Twelfth Edition. The Supplement
`II was
`promulgated on December 15, 1994 (by Notification
`No. 384 of the Ministry of Health and Welfare).
`The Panels had met as follows to prepare Supple
`ment drafts: Panel on the Principles of Revisions, 4
`times; First Panel on Medicinal Chemicals, 12 times;
`Second Panel on Medicinal Chemicals, 11 times; Panel
`on General Tests, 7 times; Panel on Preparations, 7
`times; Panel on Nomenclature, 9 times; Panel on
`Crude Drugs, 4 times; Panel on the Selection of Arti
`cles, twice; Panel on Excipients, 5 times.
`In consequence of this revision, the JP Twelfth Edi
`tion with Supplement II carries 806 articles in Part I,
`of which 781 articles have been brought forward from
`Part I of the JP Twelfth Edition (including Supple
`ment I), and 25 articles have been newly admitted; and
`470 articles in Part II, of which 469 articles have been
`brought forward from Part II of the main volume,
`though 3 articles have been combined in one article,
`and one article has been newly admitted.
`It should be noted that in the preparation of the
`drafts of this supplement, generous cooperation was
`given by the Technical Committee of the Pharmaceuti
`cal Manufacturer's Association of Tokyo and of Osa
`ka, the Crude Drugs Association of Tokyo, the Federa
`tion of Crude Drugs Associations of Japan, the Japan
`Flavor and Fragrance Manufacturer's Association, the
`Japan Pharmaceutical Manufacturer's Association,
`the Japanese Society of Hospital Pharmacists,
`the
`Japan Pharmaceuticd Association, and the Japan Oil
`seed Processors Association.
`The revision work was further continued in the Sub
`committee on JP. The general notices,
`the general
`rules for preparations,
`the general rules for crude
`drugs, the general tests, and monographs on drugs, for
`which discussions were finished between September
`1994, just after execution of Supplement II of the JP
`Twelfth Edition, and September 1995, were prepared
`as addition and revision drafts for the Thirteenth Edi
`tion of JP. The drafts were examined by the Commit
`tee on JP in November 1995, followed by the Execu
`tive Committee of CPAC, and then submitted to the
`Minister of Health and Welfare in December of the
`same year as the JP Thirteenth Edition.
`The Panels had met as follows to prepare the drafts:
`Panel on the Principles of Revisions, 4 times; First
`Panel on Medicinal Chemicals, 10 times; Second Panel
`on Medicinal Chemicals, 9 times; Panel on General
`Tests, 8 times; Panel on Preparations, 6 times; Panel
`
`JP XIII
`
`on Nomenclature, 11 times; Panel on Crude Drugs, 9
`times; Panel on the Selection of Articles, twice; Panel
`on Excipients, 9 times; Panel on Material Sciences, 6
`times; and Panel of Biological Drugs, 6 times.
`It should be noted that in the preparation of the
`drafts, generous cooperation was given by the Techni
`cal Committee of the Pharmaceutical Manufacturer's
`Association of Tokyo and of Osaka, the Crude Drugs
`Association of Tokyo,
`the Japan Kampo-Medicine
`Manufacturer's Association, the Federation of Crude
`Drugs Associations of Japan, the Japan Flavor and
`Fragrance Manufacturer's Association,
`the Japan
`Pharmaceutical Manufacturer's Association,
`the
`Japanese Society of Hospital Pharmacists, the Japan
`Pharmaceutical Association, and the Japan Oilseed
`Processors Association.
`In the reelection of the members of CPAC which
`took place in November 1991 when their terms ex
`pired, Mitsuru Uchiyama resigned as chairman of the
`Committee on JP, and Tadao Terao was elected to suc-
`ceed him. After that, biannual reelection of the Com
`mittee members was conducted twice; in November
`1993Tadao Terao resigned as chairman of the Commit
`tee on JP, and Mitsuru Uchiyama was elected to suc
`ceed him, then in November 1995 Mitsuru Uchiyama
`was reelected as the Committee chairman.
`In consequence of the above revision, the JP Thir
`teenth Edition carries 824 articles in Part I, of which
`804 articles have been brought forward from Part I of
`the JP Twelfth Edition, and 20 articles have been new
`ly admitted; and 468 articles in Part II, of which 458 ar
`ticles have been brought forward from Part II of the
`main volume, though 2 articles have been combined in
`one article, and 10 articles have been newly admitted.
`There are 2 articles in Part I and 11 articles in Part II
`of the Twelfth Edition which have not been admitted
`to the Thirteenth Edition.
`The principles of description and the salient points
`of the revision in this volume are as follows:
`
`1. The JP Thirteenth Edition comprises the follow
`ing items, in order: Notification of the Ministry of
`Health and Welfare; Contents; Preface; General No
`tices; General Rules for Preparations; General Tests,
`Processes and Apparatus; Monographs on Drugs in
`Part I and General Notices; General Rules for Crude
`Drugs; General Rules for Preparations; General Tests,
`Processes and Apparatus; Monographs on Drugs in
`Part II; Infrared Reference Spectra of Drugs in Part I
`and in Part II, General Information, and Atomic
`Weights Table followed by the Index.
`
`2. The articles in General Tests, Processes and Ap
`paratus,
`in Monographs on Drugs and in Infrared
`Reference Spectra are respectively placed in alphabeti
`cal order.
`
`3. The following items in each monograph are put
`in the order shown below, except that unnecessary
`items are omitted depending on the nature of the drug:
`(1) English title
`(2) Commonly used name(s)
`(3) Latm title (only for Crude Drugs)
`(4) Structural formula or empirical formula
`
`Mylan v. Qualicaps, IPR2017-00203
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`
`

`

`JP XIII
`
`Preface
`
`iii
`
`(5)
`(6)
`(7)
`(8)
`
`(9)
`(10)
`(11)
`(12)
`(13)
`(14)
`(15)
`(16)
`
`Molecular formula and molecular weight
`Chemical name
`Origin
`Limits of the content of the ingredient(s) and/or
`the unit of potency
`Labeling requirements
`Method of preparation
`Description
`Identification tests
`Specific physical and/or chemical values
`Purity tests
`Loss on drying, loss on ignition, and/or water
`Residue on ignition, total ash, and/or acid-in
`soluble ash
`(17)
`Special tests
`Assay or the content of the ingredient(s)
`(18)
`Containers and storage
`(19)
`(20)
`Expiration date
`(21)
`Others
`the following
`In each monograph on a drug,
`4.
`physical and chemical values representing the proper
`ties and quality of the drug are given in the order indi
`cated below in the same manner, except that unnecessa
`ry items are omitted depending on the nature of the
`drug:
`(1) Alcohol number
`(2) Absorbance
`(3) Congealing point
`(4) Refractive index
`(5) Optical rotation
`(6) Viscosity
`(7) pH
`(8)
`Specific gravity
`(9) Boiling point
`(10) Melting point
`(11) Acid value
`(12) Saponification value
`(13) Ester value
`(14) Hydroxyl value
`(15)
`Iodine value
`
`following
`the
`comprise
`Identification tests
`5.
`items, which are generally put in the order given be
`low:
`(1) Coloration reactions
`(2) Precipitation reactions
`(3) Decomposition reactions
`(4) Derivative
`(5) Visible, ultraviolet or infrared spectra
`(6)
`Special reactions
`(7) Cations
`(8) Anions
`
`6. Purity tests comprise the following items, which
`are generally put in the order given below, except that
`unnecessary items are omitted depending on the nature
`of the drug:
`(1) Color
`(2) Odor
`(3) Clarity and/or color of solution
`(4) Acidity or alkalinity
`(5) Acid
`(6) AlkaU
`
`(7) Chloride
`(8) Sulfate
`(9) Sulfite
`(10) Nitrate
`(11) Nitrite
`(12) Carbonate
`(13) Bromide
`(14)
`Iodide
`(15) Soluble halide
`(16) Thiocyanate
`(17)
`Selenium
`(18) Cationic salts
`(19) Ammonium
`(20) Heavy metals
`Iron
`(21)
`(22) Manganese
`(23) Chromium
`(24) Bismuth
`(25) Tin
`(26) Aluminum
`(27) Zinc
`(28) Cadmium
`(29) Mercury
`(30) Copper
`(31) Lead
`(32) Silver
`(33) Alkaline earth metals
`(34) Arsenic
`(35) Foreign matter
`(3Q Related substances
`(37) Other mixtures
`(38) Readily carbonizable substances
`7. The following provisions in General Notices are
`revised:
`(1) The "contents of crude drugs" is omitted from
`the items which are given for information, be
`cause the provision on contents in the Descrip
`tion is omitted from the monographs for crude
`drugs, and "storage under the Containers and
`storage in monographs on preparations" is
`added to the items which are given for informa
`tion.
`for concentration, pressure,
`(2) Principal units
`weight, etc. and their abbreviations are har
`monized with the international units.
`(3) The definition of the term "a light-resistant con
`tainer" is omitted, and that of the term "light-
`resistant" is added.
`(4) The definition of the containers is revised to
`make it clearer.
`8. The following revisions are made in General
`Rules for Preparations.
`the description of capsule
`Under Capsules,
`bases for soft capsule is less restrictive.
`9. The following revisions are made in General
`Rules for Crude Drugs.
`Titles of newly added monographs on crude
`drugs are included in the list of the crude drugs to
`which General Rules for Cfude Drugs and the
`Crude Drugs in General Tests, Processes and Ap
`paratus are applicable.
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 11/22
`
`

`

`iv
`
`Preface
`
`JP XIII
`
`10. The following test is added to the General Tests,
`Processes and Apparatus:
`X-Ray Powder DiflEraction Method
`11. Partial revisions are made in the following items
`of the General Tests, Processes and Apparatus:
`(1) Atomic Absorption Spectrophotometry
`(2) Bacterial Endotoxins Test
`(3) Content Uniformity Test
`(4) Determination of Specific Gravity and Density
`(In JP XII, Specific Gravity Determination)
`(5) Dissolution Test
`(6) Gas Chromatography
`(7) Liquid Chromatography
`(8) Test Methods for PlasticContainers (In JP XII,
`Test for Plastic Containers for Aqueous Infu
`sions)
`(9) Viscosity Determination
`(10) Volatile Contaminants in Ethanol (In JP XII,
`Ketone, Isopropanol and Tertiary Butanol Test)
`(11) Water Determination (Karl Fischer Method)
`(12) Weight Variation Test
`12. Amino Acid Chromatography is deleted from
`the General Tests, Processes and Apparatus as this test
`was combined under Liquid Chromatography.
`13. The following reference standards are newly
`added.
`(1) Alprostadil
`(2) Berberine Chloride
`(3) Carbidopa
`(4) Ciclosporin
`(5) Fluorometholone
`(6) Glycyrrhizinic Acid
`(7) High Molecular Weight Urokinase
`(8) Hydroxypropyl Methylcellulose Phthalate
`(9) Maltose
`(10) Ubidecarenone
`14. English and Latin titles of drugs are derived, in
`principle, from International Nonproprietary Names
`(INN) for Pharmaceutical Substances recommended
`by the World Health Organization. The chemical
`names are based on the rules of the International Un
`ion of Pure and Applied Chemistry (lUPAC).
`15. Molecular formulas of organic compounds be
`gin with C and then H, followed by other involved ele
`ments in the alphabetical order of the symbols of the
`elements.
`
`16. Structural formulas of drugs represent, as far as
`possible, steric configurations.
`17. Test procedures in monographs in Part I are, in
`principle, written in full even in corresponding mono
`graphs in Part II, and vice versa. The test procedures
`in monographs for preparations are also written in full
`even within the same part, except in the monographs
`for preparations having a corresponding monograph
`of their principal material substances.
`18. The following articles are newly added to Ofl&-
`cial Monographs:
`Part I
`(1) Alprostadil Alfadex
`
`(2) Astromicin Sulfate
`(3) Benserazide Hydrochloride
`(4) Bunazosin Hydrochloride
`(5) Carbidopa
`(Q Ciclosporin
`(7) Clinofibrate
`(8) Enflurane
`(9) Fenbufen
`(10) Flavoxate Hydrochloride
`(11) Floctafenine
`(12) Flunitrazepam
`(13) Fluorometholone
`(14) Fluphenazine Enanthate
`(15)
`lotroxic Acid
`(16) Maltose
`(17) Pantethine
`(18) Pranoprofen
`(19) Proglumide
`(20) Ubidecarenone
`
`Part II
`(1) Artemisia Capillaris Flower
`(2)
`Powdered Cellulose
`Powdered Dioscorea Rhizome
`(3)
`(4)
`Powdered Fennel
`Aspergillus Galactosidase
`(5)
`Ipecac Syrup
`(6)
`(7)
`Mallotus Bark
`Powdered Peach Kernel
`(8)
`Powdered Polyporus Sclerotium
`(9)
`(10)
`Urokinase
`19. The following articles are deleted from Official
`Monographs:
`Parti
`(1) Hetacillin Potassium
`(2) Selenomethionine (^^Se) Injection
`
`Part II
`(1) Compound Benzethonium and Talc Powder
`(2) Chloral and Salicylic Acid Spirit
`(3) Diphenhydramine and Calcium Powder
`(4) Compound Iodine and Capsium Spirit
`(5) Compound Nux Vomica Extract and Diastase
`Powder
`(6) Pepsin Lemonade
`(7) Phenolated Water with Hydrochloric Acid
`(8) Salicylated Phenol Ointment
`(9) Compound Scopolia Extract and Aluminum
`Hydroxide Powder
`(10) Scopolia Extract, Sodium Bicarbonate and Alu
`minum Silicate Powder
`(11) Compound Scopolia Extract, Sodium Bicar
`bonate and Aluminum Hydroxide Powder
`20. Disintegration Test or Dissolution Test is added
`to the following monographs:
`Parti
`(1) Baclofen Tablets
`(2) Bencyclane Fumarate Tablets
`(3) Diclofenamide Tablets
`(4) Dydrogesterone Tablets
`(5) Estriol Tablets
`(Q Etacrynic Acid Tablets
`(7) Fosfestrol Tablets
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 12/22
`
`

`

`JP XIII
`
`Preface
`
`(8)
`Isoniazid Tablets
`(9) Nicomol Tablets
`(10) Norgestrel and Ethinylestradiol Tablets
`(11) Piperazine Phosphate Tablets
`Sulfinpyrazone Tablets
`(12)
`(13) Tipepidine Hibenzate Tablets
`
`21. Microbial limit is added to the following mono-
`graphs:
`Part II
`(1) Microcrystalline Cellulose (In JP XII, Crystal
`line Cellulose)
`(2) Powdered Cellulose
`Ipecac Syrup
`(3)
`22. The following monographs are changed in some
`item or items by addition or revision:
`Part I
`(1) Acetaminophen
`(2) Acetylcholine Chloride for Injection
`(3) Albumin Tannate
`(4) Amidotrizoic Acid
`(5) Amyl Nitrite
`(6) Arginine Hydrochloride
`(7) Arginine Hydrochloride Injection
`(8) Arsenic Trioxide
`(9) Baclofen Tablets
`(10) Bencyclane Fumarate Tablets
`(11) Betamethasone Valerate
`(12) Bisacodyl
`(13) Busulfan
`(14) Calcium Chloride
`(15) Calcium Chloride Injection
`(16) Calcium Polystyrene Sulfonate
`(17) Carbazochrome Sodium Sulfonate
`(18) Chlordiazepoxide
`(19) Chlordiazepoxide Powder
`(20) Chlordiazepoxide Tablets
`(21) Chlorphenesin Carbamate
`(22) Chlorpropamide
`(23) Chlorpropamide Tablets
`(24) Clofibrate
`(25) Clofibrate Capsules
`(26) Clonazepam
`(27) Cocame Hydrochloride
`(28) Codeine Phosphate
`1% Codeine Phosphate Powder
`(29)
`10% Codeine Phosphate Powder
`(30)
`(31) Codeine Phosphate Tablets
`(32) Cyclandelate
`(33) Dantrolene Sodium
`(34) Dextran 40
`(35) Dextran 40 Injection
`(36) Dextran 70
`(37) Dextran 70 Injection
`(38) Dextromethorphan Hydrobromide
`(39) Dibucaine Hydrochloride
`(40) Diclofenamide Tablets
`(41) Dihydrocodeine Phosphate
`1% Dihydrocodeine Phosphate Powder
`(42)
`10% Dihydrocodeine Phosphate Powder
`(43)
`(44) Diphenhydramine Hydrochloride
`(45) Doxapram Hydrochloride
`(46) Droperidol
`
`(47) Dydrogesterohe Tablets
`(48) Estradiol Benzoate
`(49) Estradiol Benzoate Injection (Aqueous Suspen
`sion)
`(50) Estriol Tablets
`(51) Etacrynic Acid Tablets
`(52) Ethylmorphine Hydrochloride
`(53) Fentanyl Citrate
`(54) Ferrous Sulfate
`(55)
`Fosfestrol
`(56)
`Fosfestrol Tablets
`(57) Fructose
`(58)
`Fructose Injection
`(59)
`Glucose
`(60) Glucose Injection
`(61) Halothane
`(62) Hydralazine Hydrochloride Powder
`(63) Hydralazine Hydrochloride Tablets
`(64) Hydrochlorothiazide
`(65) Hydrocortisone Sodium Succinate
`(66)
`Indometacin
`(67)
`Indometacin Capsules
`(68)
`Indometacin Suppositories
`(69)
`lopanoic Acid
`(70)
`lotalamic Acid
`(71)
`Isoniazid
`(72)
`Isoniazid Tablets
`(73) Ketamine Hydrochloride
`(74) Levallorphan Tartrate
`(75) Levallorphan Tartrate Injection
`(76) Lidocaine
`(77) Lidocaine Injection
`(78) D-Mannitol
`(79) D-Mannitol Injection
`(80) Meglumine Amidotrizoate Injection
`(81) Meglumine Sodium Amidotrizoate Injection
`(82) Mepivacaine Hydrochloride
`(83) Mepivacaine Hydrochloride Injection
`(84) Methyldopa
`(85) Metronidazole
`(86) Morphine Hydrochloride
`(87) Morphine Hydrochloride Injection
`(88) Morphine Hydrochloride Tablets
`(89) Nicomol Tablets
`(90) Norgestrel and Ethinylestradiol Tablets
`(91) Noscapine
`(92) Orciprenaline Sulfate
`(93) Oxethazaine
`(94) Oxycodone Hydrochloride
`(95) Pethidine Hydrochloride
`(96) Pethidine Hydrochloride Injection
`Piperazine Phosphate
`(97)
`(98) Piperazine Phosphate Tablets
`(99) Potassium Iodide
`(100) Prednisolone Sodiimi Succinate for Injection
`(101) Prednisolone Succinate
`(102) Procaine Hydrochloride
`Procaine Hydrochloride Injection
`(103)
`(104) Procaterol Hydrochloride
`(105)
`Promethazine Hydrochloride
`(106) Pyrantel Pamoate
`(107) Quinine Sulfate
`(108) Reserpine
`
`Mylan v. Qualicaps, IPR2017-00203
`QUALICAPS EX. 2016 - 13/22
`
`

`

`vi
`
`Preface
`
`(109) Reserpine Powder
`(110) Reserpine Tablets
`(111) Salbutamol Sulfate
`(112) 10% Sodium Chloride Injection
`(113)
`Isotonic Sodium Chloride Solution
`(114) Sodium lopodate
`(115) Sodium lopodate Capsules
`(116) Sulfamethizole
`(117) Sulfamethoxazole
`(118) Sulfamonomethoxine
`(119) Sulfinpyrazone Tablets
`(120) Suxamethonium Chloride
`(121) Suxamethonium Chloride for Injection
`(122) Suxamethonium Chloride Injection
`(123) Thiamine Hydrochloride
`(124) Thiamine Hydrochloride Injection
`(125) Thiamine Hydrochloride Powder
`(126) Tipepidine Hibenzate Tablets
`(127) Triclofos Sodium
`(128) Triclofos Sodium Syrup
`(129) Xylitol
`(130) Xylitol Injection
`
`Part II
`(1) Akebia Stem
`(2) Areca
`(3) Asiasarum Root
`(4) Astragalus Root
`(5) Atractylodes Lancea Rhizome
`(6) Powdered Atractylodes Lancea Rhizome
`(7) Atractylodes Rhizome
`(8) Powdered Atractylodes Rhizome
`(9) Bear Bile
`(10) Beef Tallow
`(11) Belladonna Extract
`(12) Belladonna Root
`(13) Cacao Butter
`(14) Camellia Oil
`(15) Capsicum
`(IQ Capsules
`(17) Carnauba Wax
`(18) Castor Oil
`(19) Microcrystalline Cellulose (In JP XII, Crystal
`line Cellulose)
`(20) Cellulose Acetate Phthalate
`(21) Cimicifuga Rhizome
`(22) Coconut Oil
`(23) Powdered Coix Seed
`(24) Coptis Rhizome
`(25) Powdered Coptis Rhizome
`(26) Corn Oil
`(27) Corydalis Tuber
`(28) Dioscorea Rhizome
`(29) EphedraHerb
`(30) Ethanol
`(31) Dehydrated Ethanol
`(32) Ethanol for Disinfection
`(33) Evodia Fruit
`(34) Forsythia Fruit
`(35) Powdered Gambir
`(36) Gardenia Fruit
`(37) Ginger
`(38) Powdered Ginger
`
`JP XIII
`
`(39) Glycyrrhiza
`(40) Glycyrrhiza Extract
`(41) Crude Glycyrrhiza Extract
`(42) Powdered Glycyrrhiza
`(43) Hydroxypropylmethylcellulose 2208
`(44) Hydroxypropylmethylcellulose 2906
`(45) Hydroxypropylmethylcellulose 2910
`(4^ Ipecac
`(47) Powdered Ipecac
`(48) Lactose
`(49) Hydrous Lanolin
`(50) Purified Lanolin
`(51) Lard
`(52) Magnolia Bark
`(53) Powdered Magnolia Bark
`(54) Methylcellulose
`(55) Morphine and Atropine Injection
`(56) Moutan Bark
`(57) Powdered Moutan Bark
`(58) Mulberry Bark
`(59) OUveOil
`(60) Opium Alkaloids and Atropine Injection
`(61) Opium Alkaloids and ScopolamineInjection
`(62) Weak OpiumAlkaloidsand Scopolamine Injec
`tion
`(63) Opium Alkaloids Hydrochlorides
`(64) Opium Alkaloids Hydrochlorides Injection
`(65) Oriental Bezoar
`(66) Compound Oxycodone and Atropine Injection
`(67) Compound Oxycodone Injection
`(68) Powdered Panax Rhizome
`(69) Light Liquid Paraffin
`(70) Liquid Paraffin
`(71) Peanut Oil
`(72) Peony Root
`(73) Powdered Peony Root
`(74) Yellow Petrolatum
`(75) Phellodendron Bark
`(76) Powdered Ph