`
`InnoPharma Exhibit 1113.0001
`
`

`

`
`
`‘ THE leTED STATES PHARMACOPEIA
`
`THE NATIONAL FORMULARY.
`
`By authority of the United Stan’s Pharmacopeial
`Convention. Ina, meelfng at Washington, D. C,
`March 8—I0, 1990. Prepared by the Committee of
`Revision and published by the Board of Truxtees
`
`Official from January 1, I995
`
`UNITED STATES PHARMACOPEIAL CONVENTION, INC.
`12601 Twinbrook Parkway, Rockville, MD 20852
`
`InnoPharma Exhibit 1113.0002
`
`

`

`
`
`1 LB County Street. Taunton. MA 02780-3795
`
`The United States Pharmacopeial Convention. Inc.
`I994
`to
`I260] Twittth Parkway. Rotkville. MD 20352.
`AN right: reserved
`ISSN 0195-7996
`ISBN 0913595464 [cloth]
`033595-310 {leather}
`
`Primed by Rand McNaIly.
`
`InnoPharma Exhibit 1113.0003
`
`NOTICE AND WARNING
`
`Concerning US. Patent or Trademark Rights
`
`The inclusion in the Pharmacopeia or in the National Formulary of a monograph on any
`drug in respect to which patent or trademark rights may exist shall not be deemed. and is
`not intended as. a gram of. or authority to exercise, any right or privilege protected by such
`patent or trademark. All such rights and privileges are vesteti in the patent or trademark
`owner. and no other person may exercise the same without express permission. authority. or
`iicense secured from such patent or trademark owner.
`
`Concerning Use of USP or NF Text
`Attention is called to the fuel that US? and NF text is fully copyrighted. Authors and
`others wishing to Use portions of the text should request permission to do so from the
`Secretary of the USPC Board of Trustees.
`
`

`

`
`
`General Notices
`and Requirements
`
`Applying to Standards, Tests,
`Assays, and Other Specifications
`of the United States Pharmacopeia
`
`Guide to GENERAL NOTICES AND REQUIREMENTS
`
`Title .
`
`.
`
`. 2
`
`“Official” and “Official
`Articles” .
`.
`. 2
`
`Nutritional Supplements .
`
`.
`
`. 2
`
`Atomic Weights and Chemical
`Formulas .
`.
`. 2
`
`. 3
`.
`Abbreviations .
`Abbreviated Statements in
`Monographs . .. 3
`
`Significant Figures and
`Tolerances .
`.
`. 3
`
`Equivalence Statements in Titrimetric
`Procedures .. . 3
`Tolerances .. . 3
`Interpretation of Requirements .
`
`. 3
`
`.
`
`General Chapters .
`
`.
`
`. 4
`
`. 4
`
`.
`Pharmacopeial Forum .
`Phannacopeial Previews .
`.
`. 4
`In-process Revision .
`.
`. 4
`Stimuli to the Revision Process .
`Nomenclature .
`.
`, 4
`.
`Interim Revision Announcement .
`Official Reference Standards .
`.
`. 4
`
`.
`
`. 4
`
`. 4
`
`Reagent Standards .
`
`.
`
`. 4
`
`USP Reference Standards .
`
`.
`
`. 4
`
`Units of Potency .
`
`.
`
`. 5
`
`Ingredients and Processes .
`Water... 5
`Alcohol .
`.
`. 5
`Alcohol 5
`Dehydrated Alcohol .
`Denatured Alcohol .
`.
`
`. 5
`.
`. 5
`
`.
`
`. 5
`
`. 6
`.
`Added Substances .
`. 6
`.
`Nutritional Supplements .
`Additional Ingredients t
`.
`. ti
`Inert Headspace Gases .
`. 6
`Colors .
`.
`. 6
`Ointments and Suppositories .
`
`.
`
`.
`
`. 6
`
`Tests and Assays .
`
`. . 6
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`.
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`.
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`.
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`. 8
`
`.r
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`. 8
`
`.
`
`. B
`
`. 6
`.
`Apparatus .
`.
`. 6
`Steam Bath .
`Water Bath . .. 6
`Foreign Substances and Impurities .
`Procedures .
`.
`. 7
`Blank Determination .
`Desiccator .
`.
`. 8
`Dilution .
`.
`. 8
`Drying to Constant Weight .
`Filtration .
`.
`. 8
`. 8
`.
`Identification Tests .
`Ignition to Constant Weight .
`Indicators .
`.
`. 8
`Logarithrns .
`.
`. B
`Microbial Strains
`Negligible... 3
`Odor .
`.
`. 3
`Pressure Measurements .
`Solutions .
`.
`. 9
`.
`Specific Gravity .
`Temperatures .
`.
`. 9
`Time Limit .
`.
`K 9
`Vacuum .
`.
`. 9
`Water .
`.
`. 9
`Water and Loss on Drying .. . 9
`Test Results, Statistics and
`Standards .
`.
`. 9
`Description .
`.
`. 9
`Solubility .
`.
`. 10
`Prescribing and Dispensing . ..IO
`
`. S
`
`. 9
`
`.
`
`. 9
`
`Preservation, Packaging, Storage,
`and Labeling .
`.
`. 10
`
`A
`. 10
`.
`Containers .
`Tamper-resistant Packaging .
`Light-resistant Container .
`.
`.
`
`. 10
`.
`it)
`
`.
`
`.
`
`IO
`
`.
`
`Well-closed Container .
`Tight Container .
`.
`. i0
`Hermetic Container... 11
`Single-unit Container .
`.
`. ll
`Single-dose Container .
`. ll
`.
`Unit-dose Container .
`.
`. ll
`I I
`Multiple-unit Container .
`l
`. ll
`.
`Multiple-dose Container .
`Storage Temperature .. . ll
`Freezer . .
`. 11
`Cold
`11
`.
`Cool .
`. 11
`Room Temperature .. . ll
`Controlled Room Temperature .
`Warm .
`.
`. 1]
`. ll
`.
`Excessive Heat .
`Protection from Freezing .
`Storage under Nonspecific
`Conditions . .. Ii
`Labeling . .. [1
`Amount of Ingredient per Dosage
`Unit... 11
`Labeling of Salts of Drugs .
`Labeling Vitamin-containing
`Products . .. l2
`Labeling Parenteral and Topical
`Preparations . .. l2
`Labeling Electrolytes .
`.
`Labeling Alcohol .
`.
`. [2
`Special Capsules and Tablets
`Expiration Date .
`.
`. 12
`
`.
`
`.
`
`. 11
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`.
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`. 12
`
`. 12
`
`. ll
`
`12
`
`Vegetable and Animal
`Substances .
`.
`. 13
`
`. 13
`.
`Foreign Matter .
`Preservation .
`.
`. 13
`
`Weights and Measures .
`
`.
`
`. l3
`
`Concentrations . .
`
`. 13
`
`. 14
`.
`Percentage Measurements .
`. 14
`Percent weight in weight .
`.
`Percent weight in volume .. . 14
`Percent volume in volume .
`.
`. l4
`
`InnoPharma Exhibit 1113.0004
`
`

`

`Generni Notices
`
`13
`
`ical contamination by means of suitable agents or
`processes that leave no harmful residues.
`
`wnicrrrs AND MEASURES
`
`Mind = mcflflmd
`
`The international System of Units (Si) is used in
`this Pharmacopeia. The SI metric and other units,
`and the symbols commonly employed, are as follows.
`Ci = curie
`Eq = gram-equivalent
`mCi = millicuric
`weight (equivalent)
`“Ci =2 microcurie
`mE = milliequivnleni
`nCi = nanocurie
`mo = gram-molecular
`weight (mole)
`Da = dalton (relative mo-
`lecular mass)
`mmol = millimole
`Osmol = osmole
`mDsmol = milliosrnole
`Hz = hertz
`kHz = kilohertz
`ME: = megahertz
`MeV = million electron
`volts
`keV = kilo-electron volt
`mV = millivolt
`psi = pounds per square
`inch
`Pa = pascal
`kPa = kilopascal
`g = gravity (in
`centrifugation)
`
`m = meter
`dm =- decimctcr
`em = centimeter
`mm = millimeter
`urn = micrometer
`(0.001 mm)
`nin =- nanometer‘
`kg =' kilogram
`= gram "
`mg -== milligram
`its: meg = micrograml‘
`rig = nanogram
`pg re picogrnm
`dL E deciliter
`L = liter
`mi. =- milliliter: i
`uL = microliter
`
`' Formerly the symbol min (for millimicron] was used.
`“ The gram is the unit of mass that is used to measure quan-
`tities of materials. Weight. which is a measure of the gravita-
`tional force acting on the mass of a material, is proportional to.
`and may differ slightly from. its mass due to the effects of factors
`such as gravity. temperature. latitude, and altitude. The differ-
`ence between mass and weight is considered to be insignificant
`for compendinl assa 's and tests, and the term “weight” is used
`throughout USP an NF.
`TFnrmerly the abbreviation meg was used in the Pharmaco-
`pcinl monographs: however. the symbol pig now is more widely
`accepted and thus is used in this Pharmaco eia. The term
`"gamma," symbolized by y, is frequently used or microgram in
`biochemical literature.
`NOTE—The abbreviation meg is still commonly employed to
`denote microgramis) in labeling and in prescription writing.
`Therefore. for purposes of labeling, “meg” may be used to denote
`microgrnm(s).
`$0ne milliliter (mL) is used herein as the equivalent of 1 cubic
`centimeter (cc).
`
`The International System of Units (SI) is also used
`in all radiopharmaceutical monographs. The symbols
`commonly employed are as follows.
`Bq = becqucrcl
`GBq = gigabccqucrel
`kBq = kilobccquerel
`Gy = gray
`livqu = megabec-
`mGy = milligray
`qucrel
`
`CONCENTRATIONS
`
`Molal, molar. and normal solution concentrations
`are indicated throu bout this Pharmacopeia for most
`chemical assay anti test procedures (see also Volu-
`metric Solutions in the section, Reagents, Indicators,
`and Solutions). Molality is designated by the symbol
`or preceded by a number that is the number of moles
`of the designated solute contained in one kilogram of
`
`InnoPharma Exhibit 1113.0005
`
`mining an appropriate period of time dur-
`in date
`rescriptiori drug may be retained by a
`ins WhiCh a p
`t after its dispensmg. the dispenser shall take
`.
`Panel!
`um in addiiion to any other relevant factors.
`I“to accoe 0}. the drug; the container in which it was
`the natal!" by the manufacturer and the expiration date
`tight-tin; the characteristics of the patient’s container.
`if the artido is repackaged for dispensing; the ex—
`nditions to which the article may be
`pected storage on
`ed; and the expected length of time of the course
`e
`of therapy. Unless otherWISe required, the dispenser
`'
`on taking into account the foregomg,’ place on
`gigyiabel of a multiple-unit container a suitable‘be-
`"ad-use date to limit the patient’s pseof the article.
`{593135 otherwise specified in the individual mono-
`ph, such beyond-use date shall be not later than
`a? the expiration date on the manufacturer’s con-
`tainer, or (b) one year from the date the drug 15
`dispensed, whichever is earlier.
`
`VEGETABLE AND ANIMAL SUBSTANCES
`
`The requirements for vegetable and animal sub-
`stances apply to the articles as they enter commerce;
`however, lots of such substances intended solely for
`the manufacture or isolation of volatile oils, alkaloids.
`glycosides, or other active principles may depart from
`such requirements.
`Statements of the distinctive microscopic structural
`elements in powdered substances of animal or vege—
`table origin may be included in the individual mono—
`graph as a means of determining identity, quality. or
`purity.
`
`Foreign Matter—Vegetable and animal substances
`are to be free from pathogenic organisms (see Mi-
`crobiological Attributes of Nonsteri'le Phormacew
`ticai Products (1 l
`1 1)), and are to be as free as rea-
`sonably practicable from microorganisms, insects, and
`other animal contamination,
`including animal ex-
`creta. They shall show no abnormal discoloration,
`abnormal odor. sliminess, or other evidence of dete-
`rioration.
`The amount of foreign inorganic matter in vege-
`table or animal substances, estimated as Acid—insol-
`uble ash, shall not exceed 2 percent of the weight of
`thesubstancc. unless otherwise specified in the in-
`dividual monograph.
`Before vegetable substances are ground or pow-
`dered. stones, dust. lumps of soil, and other foreign
`Inorganic matter are to be removed by mechanical or
`other suitable means.
`ta commerce it is seldom-possible to obtain vege-
`ad 1? Substances that are Without some. adherent or
`maxed. innocuous, foreign matter, which usually is
`wise ctrimental.
`'No poisonous, dangerous, or other-
`em nFOquus foreign matter or resrdues may be pres-
`nm' Oteign matter includes any part of the plant
`Specified as constituting the substance.
`Preservation—Vegetable or animal substances may
`be protected from insect infestation or microbiolog—
`
` i l l
`
`win-ullu—IruniILLE-l‘d:
`
`g—p—
`
`

`

`14
`
`General Notices
`
`USP 23
`
`
`
`the designated solvent. Molarity is designated by the
`symbol M preceded by a number that is the number
`of moles of the designated solute contained in an
`amount of the designated solvent that is sufficient to
`prepare one liter of solution. Normality is designated
`by the symbol N preceded by a number that is the
`number of equivalents of the designated solute con—
`tained in an amount of the designated solvent that is
`sufficient to prepare one liter of solution.
`
`Percentage Measurements—Percentage concentra—
`tions are expressed as follows:
`Percent weight
`in weight—(w/w) expresses the
`number of g of a constituent in 100 g of solution or
`mixture.
`
`in volume—(w/v) expresses the
`Percent weight
`number of g of a constituent in 100 mL of solution.
`
`and is used regardless of whether water or another
`liquid is the solvent.
`Percent volume in volume—(WV) expresses the
`number of mL of a constituent in 100 mL of solution.
`The term percent used without qualification means_
`for mixtures of solids and semisolids, percent weight
`in weight; for solutions or suspensions of solids in
`liquids, percent weight
`in volume; for solutions of
`liquids in liquids. percent volume in volume; and for
`solutions of gases in liquids, percent weight in volume,
`For example, a 1 percent solution is prepared by dis-
`solving 1 g of a solid or semisolid, or 1 mL of a liquid,
`in sufficient solvent to make 100 ml. of the solution.
`In the dispensing of prescription medications. slight
`changes in volume owing to variations in room tem-
`peratures may be disregarded.
`
`>>>>3~3~
`
`
`
`hI-I-“loo—I“.—
`
`4r—p—Wm‘
`
`InnoPharma Exhibit 1113.0006
`
`