Designation as a Pharmacy bulk package is limited to prepara-〈1〉 INJECTIONS
tions from Nomenclature categories 1, 2, or 3 as defined above.Pharmacy bulk packages, although containing more than one single do, are exempt from the multiple-do container volume limit of 30 mL and the requirement that they contain a substance or suitable mixture of substances to prevent the growth of microorganisms.Where a container is offered as a Pharmacy bulk package, the INTRODUCTION
label shall (a) state prominently “Pharmacy Bulk Package—Not for direct infusion,” (b) contain or refer to information on proper tech-Parenteral articles are preparations intended for injection through niques to help assure safe u of the product, and (c) bear a state-the skin or other external boundary tissue, rather than through the ment limiting the time frame in which the container may be ud alimentary canal, so that the active substances they contain are ad-once it has been entered, provided it is held under the labeled stor-ministered, using gravity or force, directly into a blood vesl, or-age conditions.
gan, tissue, or lesion. Parenteral articles are prepared scrupulously by methods designed to ensure that they meet Pharmacopeial re-quirements for sterility, pyrogens, particulate matter, and other con-LARGE - AND SMALL -VOLUME INJECTIONS
taminants, and, where appropriate, contain inhibitors of the growth of microorganisms. An Injection is a preparation intended for par-Where ud in this Pharmacopeia, the designation Large-volume enteral administration and/or for constituting or diluting a parenteral intravenous solution applies to a single-do injection that is in-article prior to administration.
tended for intravenous u and is packaged in containers labeled as containing more than 100 mL. The designation Small-volume Injec-tion applies to an Injection that is packaged in containers labeled as NOMENCLATURE AND DEFINITIONS
containing 100 mL or less.
BIOLOGICS
Nomenclature *
The following nomenclature pertains to five general types of The Pharmacopeial definitions for sterile preparations for paren-preparations, all of which are suitable for, and intended for, paren-teral u generally do not apply in the ca of the biologics becau teral administration. They may contain buffers, prervatives, or of their special nature and licensing requirements (e Biologics other added substances.〈1041〉).
1.[DRUG] Injection—Liquid preparations that are drug sub-stances or solutions thereof.
2.[DRUG] for Injection—Dry solids that, upon the addition of
INGREDIENTS
suitable vehicles, yield solutions conforming in all respects to the requirements for Injections.3.[DRUG] Injectable Emulsion—Liquid preparations of drug
Vehicles and Added Substances
substances dissolved or disperd in a suitable emulsion medium.Aqueous Vehicles—The vehicles for aqueous Injections meet 4.[DRUG] Injectable Suspension—Liquid preparations of sol-the requirements of the Pyrogen Test 〈151〉 or the Bacterial Endo-ids suspended in a suitable ins Test 〈85〉, whichever is specified. Water for Injection gener-5.[DRUG] for Injectable Suspension—Dry solids that, upon the
外文书
protectally is ud as the vehicle, unless otherwi specified in the individ-addition of suitable vehicles, yield preparations conforming ual monograph. Sodium chloride may be added in amounts in all respects to the requirements for Injectable Suspensions.
sufficient to render the resulting solution isotonic; and Sodium Chloride Injection, or Ringer’s Injection, may be ud in whole or in part instead of Water for Injection, unless otherwi specified in Definitions
the individual monograph. For conditions applying to other ad-juvants, e Added Substances in this chapter.
Other Vehicles—Fixed oils ud as vehicles for nonaqueous In-jections are of vegetable origin, are odorless or nearly so, and have PHARMACY BULK PACKAGE
no odor suggesting rancidity. They meet the requirements of the test for Solid paraffin under Mineral Oil, the cooling bath being main-A Pharmacy bulk package is a container of a sterile preparation tained at 10°, have a Saponification Value between 185 and 200for parenteral u that contains many single dos. The contents are (e Fats and Fixed Oils 〈401〉), have an Iodine Value between 79intended for u in a pharmacy admixture program and are re-and 141 (e Fats and Fixed Oils 〈401〉), and meet the requirements stricted to the preparation of admixtures for infusion or, through a of the following tests.
sterile transfer device, for the filling of empty sterile syringes.Unsaponifiable Matter—Reflux on a ste
am bath 10 mL of the oil The closure shall be penetrated only one time after constitution with 15 mL of sodium hydroxide solution (1 in 6) and 30 mL of with a suitable sterile transfer device or dispensing t which allows alcohol, with occasional shaking until the mixture asured dispensing of the contents. The Pharmacy bulk package Transfer the solution to a shallow dish, evaporate the alcohol on a is to be ud only in a suitable work area such as a laminar flow steam bath, and mix the residue with 100 mL of water: a clear solu-hood (or an equivalent clean air compounding area).
tion results.
*
This nomenclature has been adopted by the USP Drug Nomenclature Committee for Free Fatty Acids—The free fatty acids in 10g of oil require for implementation by supplemental revisions of USP 23-NF 18. For currently official neutralization not more than 2.0 mL of 0.020N sodium hydroxide monograph titles in the form Sterile [DRUG] that have not yet been revid, the following nomenclature continues in u in this Pharmacopeia:(1) medicaments or (e Fats and Fixed Oils 〈401〉).
solutions or emulsions thereof suitable for injection, bearing titles of the form [DRUG]Synthetic mono- or diglycerides of fatty acids may be ud as Injection; (2) dry solids or liquid concentrates containing no buffers, diluents, or other vehicles, provided they are liquid and remain clear when cooled to added substances, and which, upon the addition of suitable solvents, yield solutions conforming in all respects to the requirements for Injections, and which are 10° and have an Iodine Value of not more than 140 (e Fats and distinguished by titles of the form Sterile [DRUG]; (3) preparations the same as tho Fixed Oils 〈401〉).
described under (2) except that they contain one or more buffers, diluents, or other The and other nonaqueous vehicles may be ud, provided they added substances, and which are distinguished by titles of the form [DRUG] for are safe, in the volume of Injection administered, and also provided Injection; (4) solids which are suspended in a suitable fluid medium and which are not to be injected intravenously or into the spinal canal, distinguished by titles of the form they do not interfere with the therapeutic efficacy of the preparation Sterile [DRUG] Suspension; and (5) dry solids which, upon the addition of suitable or with its respon to prescribed assays and tests.
vehicles, yield preparations conforming in all respects to the requirements for Sterile Added Substances—Suitable substances may be added to prepa-Suspensions, and which are distinguishe
d by titles of the form Sterile [DRUG] for Suspension.
rations intended for injection to increa stability or ufulness, un-
less proscribed in the individual monograph, provided they are Containers for Injections that are intended for u as dialysis, harmless in the amounts administered and do not interfere with the hemofiltration, or irrigation solutions and that contain a volume of therapeutic efficacy or with the respons to the specified assays more than 1 L are labeled to indicate that the contents are not in-and tests. No coloring agent may be added, solely for the purpo of tended for u by intravenous infusion.
coloring the finished preparation, to a solution intended for paren-Injections intended for veterinary u are labeled to that effect. teral administration (e also Added Substances under General No-The container is so labeled that a sufficient area of the container tices and Antimicrobial Effectiveness Testing 〈51〉).remains uncovered for its full length or circumference to permit in-
spection of the contents.
Obrve special care in the choice and u of added substances in
preparations for injection that are administered in a volume exceed-
ing 5 mL. The following maximum limits prevail unless otherwi
除此之外STRENGTH AND TOTAL VOLUME FOR SINGLE- AND directed: for agents containing mercury and the cationic, surface-
active compounds, 0.01%; for chlorobutanol, cresol, phenol, and MULTIPLE-DOSE INJECTABLE DRUG PRODUCTS similar types of substances, 0.5%; and for sulfur dioxide, or an
equivalent amount of the sulfite, bisulfite, or metabisulfite of potas-For single-do and multiple-do injectable drug products, the sium or sodium, 0.2%.strength per total volume should be the primary and prominent ex-
pression on the principal display panel of the label, followed in A suitable substance or mixture of substances to prevent the
clo proximity by strength per mL enclod by parenthes. For growth of microorganisms must be added to preparations intended
containers holding a volume of less than 1 mL, the strength per for injection that are packaged in multiple-do containers, regard-
fraction of a mL should be the only expression of strength. Strength less of the method of sterilization employed, unless one of the fol-
per single mL should be expresd as mg/mL, not mg/1 mL. lowing conditions prevails: (1) there are different directions in the
The following formats are acceptable for contents of greater individual monograph; (2) the substance contains a radionuclide
than 1 mL:
with a physical half-life of less than 24 hours; and (3) the active
Total strength/total volume: 500 mg/10 mL
ingredients are themlves antimicrobial. Such substances are ud
Strength/mL: 50 mg/mL
in concentrations that will prevent the growth of or kill microorgan-
or
isms in the preparations for injection. Such substances also meet the
Total strength/total volume: 25,000 Units/5 mL requirements of Antimicrobial Effectiveness Testing 〈51〉 and Anti-
Strength/mL: 5,000 Units/mL
microbial Agents—Content 〈341〉. Sterilization process are em-
The following format is acceptable for contents of less than 1 ployed even though such substances are ud (e also Sterilization
mL: 12.5 mg/0.625 mL
and Sterility Assurance of Compendial Articles 〈1211〉). The air in
There are, however, some exceptions to expressing strength per the container may be evacuated or
be displaced by a chemically in-
total volume. In certain cas, the primary and prominent expres-ert gas. Where specified in a monograph, information regarding
sion of the total drug content per container would not be effective in nsitivity of the article to oxygen is to be provided in the labeling.
preventing medication errors (e.g., insulin). An example is the u
of lidocaine or other similar drugs ud as a local anesthetic where
the product is ordered and administered by percentage (e.g., 1%, LABELS AND LABELING
2%) or a local anesthetic in combination with epinephrine that is
expresd as a ratio (e.g., 1:100,000). In such cas, the total
strength should be expresd: for example, 1% (100 mg/10 mL).
Dry solids, which need to be reconstituted, should follow the same Labeling format, with the exceptio
n that only the total strength of the drug
should be listed, not the strength/total volume or strength/mL. NOTE—See definitions of “label” and “labeling” in Labeling in(Official February 1, 2009) the ction Prervation, Packaging, Storage, and Labeling of the
General Notices and Requirements.
The label states the name of the preparation; in the ca of a liq-Aluminum in Large-Volume Parenterals (LVPs), uid preparation, the percentage content of drug or amount of drug in Small-Volume Parenterals (SVPs), and Pharmacy a specified volume; in the ca of a dry preparation, the amount of
Bulk Packages (PBPs) Ud in Total Parenteral active ingredient; the route of administration; a statement of storage
conditions and an expiration date; the name and place of business of Nutrition (TPN) Therapy
the manufacturer, packer, or distributor; and an identifying lot num-
ber. The lot number is capable of yielding the complete manufactur-(a)The aluminum content of LVPs ud in TPN therapy must ing history of the specific package, including all manufacturing,not exceed 25 µg per L (µg/L).
filling, sterilizing, and labeling operations.(b)The package inrt of LVPs ud in TPN therapy must state Where the individual monograph permits varying concentrations that the drug product contains no more than 25 µg of alumi-of active ingredients in the large-volume parenteral, the concentra-num per L. This information must be contained in the “Pre-tion of each ingredient named in the official title is stated as if part cautions” ction of the labeling of all LVPs ud in TPN of the official title, e.g., Dextro Injection 5%, or Dextro (5%)therapy.
and Sodium Chloride (0.2%) Injection.(c)If the maximum amount of aluminum in SVPs and PBPs is The labeling includes the following information if the complete25 µg per L (µg/L) or less, instead of stating the exact formula is not specified in the individual monograph: (1) In the ca amount of aluminum that each contains, as in paragraph (d), of a liquid preparation, the percentage content of each ingredient or the immediate container label for SVPs and PBPs ud in the the amount of each ingredient in a specified volume, except that preparation of TPN parenterals (with exceptions as noted be-ingredients added to adjust to a given pH or to make the solution low) may state: “Contains
人教版七年级下英语no more than 25 µg/L of alumi-isotonic may be declared by name and a statement of their effect;num”. If the SVP or PBP is a lyophilized powder, the im-and (2) in the ca of a dry preparation or other preparation to mediate container label may state the following: “When which a diluent is intended to be added before u, the amount of reconstituted in accordance with the package inrt instruc-each ingredient, the composition of recommended diluent(s) [the tions, the concentration of aluminum will be no more than 25 name(s) alone, if the formula is specified in the individual mono-µg/L”.
graph], the amount to be ud to attain a specific concentration of(d)The maximum level of aluminum at expiry must be stated on active ingredient and the final volume of solution so obtained, a the immediate container label of all SVPs and PBPs ud in brief description of the physical appearance of the constituted solu-the preparation of TPN parenterals and injectable emulsions. tion, directions for proper storage of the constituted solution, and an The aluminum content must be stated as follows: “Contains expiration date limiting the period during which the constituted no more than __ µg/L of aluminum”. The immediate con-solution may be expected to have the required or labeled potency if tainer label of all SVPs and PBPs that are lyophilized powder it has been stored as directed.ud in the preparation of TPN solutions must contain the fol-
lowing statement: “When reconstituted in accordance with pul is prohibited, except for Potassium Chloride for Injection the package inrt instructions, the concentration of alumi-Concentrate.
num will be no more than __ µg/L.” This maximum amount of aluminum must be stated as the highest one of the follow-Neuromuscular Blocking and Paralyzing Agents
ing three levels:
recommend
(1)The highest level for the batches produced during the last
All injectable preparations of neuromuscular blocking agents and three years
cultivatedparalyzing agents must be packaged in vials with a cautionary state-(2)The highest level for the latest five batches
ment printed on the ferrules or cap overals. Both the container cap (3)The maximum level in terms of historical levels, but only un-ferrule and the cap overal must bear in black or white print til completion of production of the first five batches after July (whichever provides the greatest color contrast with the ferrule or 26, 2004.
cap color) the words: “Warning: Paralyzing Agent” or “Paralyzing The package inrt for all LVPs, SVPs, and PBPs ud in the Agent” (depending on the size of the closure system). Alternatively,preparation of TPN products must contain a warning statement.the overal may be transparent and without words, allowing for This warning must be contained in the “Warning” ction of the visualization of the warning labeling on the closure ferrule.
labeling and must state the following: “WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is Containers for Sterile Solids
impaired. Premature neonates are particularly at risk becau their kidneys are immature, and they require large amounts of calcium Containers, including the closures, for dry solids intended for and phosphate solutions that contain aluminum. Rearch indicates parenteral u do not interact physically or chemically with the that patients with impaired kidney function, including premature preparation in any manner to alter the strength, quality, or purity neonates, who receive parenteral levels of aluminum at greater than beyond the official requirements under the ordinary or customary 4 to 5 µg per kg per day accumulate aluminum at levels associated conditions of handling, shipment, storage, sale, and u.
with central nervous system and bone toxicity. Tissue loading may A container for a sterile solid permits the addition of a suitable occur at even lower rates of administration of TPN products.”
solvent and withdrawal of portions of the resulting solution or sus-pension in such manner that the sterility of the product is maintained.
PACKAGING Where the Assay in a monograph provides a procedure for the Assay preparation, in which the total withdrawable contents are to be withdrawn from a single-do container with a hypodermic nee-dle and syringe, the contents are to be withdrawn as completely as Containers for Injections
possible into a dry hypodermic syringe of a rated capacity not ex-ceeding three times the volume to be withdrawn and fitted with a Containers, including the closures, for preparations for injections 21-gauge needle not less than 2.5 cm (1 inch) in length, with care do not interact physically or chemically with the preparations in any being taken to expel any air bubbles, and discharged into a con-manner to alter the strength, quality, or purity beyond the official tainer for dilution and assay.
requirements under the ordinary or customary conditions of han-dling, shipment, storage, sale, and u. The container is made of material that permits inspection of the contents. The type of glass Volu
me in Container
preferable for each parenteral preparation is usually stated in the individual monograph. Unless otherwi specified in the individual Each container of an injection is filled with sufficient excess of monograph, plastic containers may be ud for packaging injections the labeled “size” or that volume which is to be withdrawn. See (e Containers—Plastics 〈661〉).
Injections under Pharmaceutical Dosage Forms 〈1151〉.
For definitions of single-do and multiple-do containers, e Containers in the General Notices and Requirements. Containers meet the requirements under Containers—Glass 〈660〉 and Con-DETERMINATION OF VOLUME OF INJECTION IN
tainers—Plastics 〈661〉.
Containers are clod or aled in such a manner as to prevent CONTAINERS contamination or loss of contents. Validation of container integrity must demonstrate no penetration of microbial contamination or Suspensions and emulsions must be shaken before withdrawal of chemical or physical impurities. In addition, the solutes and the ve-the contents and before the determination of t
he density. Oily and hicle must maintain their specified total and relative quantities or viscous preparations may be warmed according to the instructions concentrations when expod to anticipated extreme conditions of on the label, if necessary, and thoroughly shaken immediately be-manufacturing and processing, and storage, shipment, and distribu-fore removing the contents. The contents are then cooled to tion. Closures for multiple-do containers permit the withdrawal of 20°–25°C before measuring the volume.
the contents without removal or destruction of the closure. The clo-Single-Do Containers—Select 1 container if the volume of the sure permits penetration by a needle and, upon withdrawal of the container is 10 mL or more, 3 containers if the nominal volume is needle, clos at once, protecting the container against contamina-more than 3 mL and less than 10 mL, or 5 containers if the nominal tion. Validation of the multiple-do container integrity must in-volume is 3 mL or less. Take up individually the total contents of clude verification that such a package prevents microbial contami-each container lected into a dry syringe of a capacity not exceed-nation or loss of product contents under anticipated conditions of ing three times the volume to be measured and fitted with a 21-multiple entry and u.
gauge needle not less than 2.5 cm (1 inch) in length. Expel any air Piggyback containers are usually
indispensable
intravenous infusion containers bubbles from the syringe and needle, and then discharge the con-ud to administer a cond infusion through a connector of some tents of the syringe, without emptying the needle, into a standard-type or an injection port on the administration t of the first fluid,ized, dry cylinder (graduated to contain rather than to deliver the thereby avoiding the need for another injection site on the patient’s designated volumes) of such size that the volume to be measured body. Piggyback containers are also known as condary infusion occupies at least 40% of its graduated volume. Alternatively, the containers.
volume of the contents in mL may be calculated as the mass, in g,divided by the density. For containers with a nominal volume of 2mL or less, the contents of a sufficient number of containers may be Potassium Chloride for Injection Concentrate
pooled to obtain the volume required for the measurement, provided that a parate, dry syringe asmbly is ud for each container. The The u of a black closure system on a vial (e.g., a black flip-off contents of containers holding 10 mL or more may be determined button and a black ferrule to hold the elastomeric closure) or the u by means of opening them and emptying the contents directly into of a black band or ries of bands above the constriction on an am-
the graduated cylinder or tared beaker.
The volume is not less than the nominal volume in the ca of Injections packaged for intravascular u that may be ud for containers examined individually or, in the ca of containers with a intermittent, continuous, or bolus replacement fluid administration nominal volume of 2 mL or less, is not less than the sum of the during hemodialysis or other procedures, unless excepted above,nominal volumes of the containers taken collectively.
must conform to the 1-L restriction.
Multi-Do Containers—For Injections in multiple-do con-Injections labeled for veterinary u are exempt from packaging tainers labeled to yield a specific number of dos of a stated vol-and storage requirements concerning the limitation to single-do ume, lect 1 container, and proceed as directed for single-do containers and the limitation on the volume of multiple-do containers, using the same number of parate syringe asmblies as containers.
the number of dos specified. The volume is such that each syringe delivers not less than the stated do.
Injections in Cartridges or Prefilled Syringes—Select 1 con-FOREIGN AND PARTICULATE MATTER
tainer if the volume is 10 mL or more, 3 containers if the nominal volume is more than 3 mL and less than 10 mL, or 5 containers if All articles intended for parenteral administration shall be pre-the nominal volume is 3 mL or less. If necessary, fit the containers pared in a manner designed to exclude particulate matter as defined with the accessories required for their u (needle, piston, syringe)in Particulate Matter in Injections 〈788〉 and other foreign matter.and transfer the entire contents of each container without emptying Each final container of all parenteral preparations shall be inspected the needle into a dry tared beaker by slowly and constantly depress-to the extent possible for the prence of obrvable foreign and ing the piston. Determine the volume in mL, calculated as the mass,particulate matter (hereafter termed “visible particulates”) in its in g, divided by the density.
contents. The inspection process shall be designed and qualified to The volume measured for each of the containers is not less than ensure that every lot of all parenteral preparations is esntially free the nominal volume.
from visible particulates. Qualification of the inspection process Large-Volume Intravenous Solutions—For intravenous solu-shall be performed with reference to particulates in the visible range tions, lect 1 container. Transfer the contents into a dry measuring of a type that might emanate from the
姜太公钓鱼愿者上钩的故事manufacturing or filling pro-cylinder of such a capacity that the volume to be determined occu-cess. Every container who contents shows evidence of visible par-pies at least 40% of the nominal volume of the cylinder. Measure ticulates shall be rejected. The inspection for visible particulates the volume transferred.
may take place when inspecting for other critical defects, such as The volume is not less than the nominal volume.
cracked or defective containers or als, or when characterizing the appearance of a lyophilized product.
Where the nature of the contents or the container-closure system permits only limited capability for the inspection of the total con-Labeling on Ferrules and Cap Overals
tents, the 100% inspection of a lot shall be supplemented with the inspection of constituted (e.g., dried) or withdrawn (e.g., dark am-Only cautionary statements are to appear on the top (circle) sur-ber container) contents of a sample of containers from the lot.face of the ferrule or cap overal of a vial containing an injectable All large-volume Injections for single-do infusion and small-product. A cautionary statement is one intended to prevent an immi-volume Injections are subject to the light ob
scuration or micro-nent life-threatening situation if the injectable drug is ud inappro-scopic procedures and limits for subvisible particulate matter t priately. Examples of such statements include but are not limited to forth in Particulate Matter In Injections 〈788〉, unless otherwi the following: “Warning”, “Dilute Before Using”, “Paralyzing specified in the individual monograph. An article packaged as both Agent”, “I.M. U Only”, and “Chemotherapy”.
a large-volume and a small-volume Injection meets the require-The text must be in contrasting color and conspicuous under ordi-ments t forth for small-volume Injections where the container is nary conditions of u. The cautionary statement may appear solely labeled as containing 100 mL or less, if the individual monograph on the ferrule, provided the cap overal is constructed so as to al-states a test for Particulate Matter 〈788〉; it meets the requirements low the cautionary statement beneath the cap to be readily legible.t forth for large-volume Injections for single-do infusion where Identifying numbers or letters, such as code numbers, lot num-the container is labeled as containing more than 100 mL. Injections bers, etc., may appear on the side (skirt) surface of the ferrule on administered exclusively by the intramuscular or subcutaneous vials containing injectable products. The appearance of such identi-route or packaged and labeled for u as irrigating solutions are ex-fying data on the skirt surface of the ferrule, placed where it does empt from requirements for Particulate Matter 〈788〉.
not detract from, or interfere with, the cautionary statement on the top surface, should be considered to be a beneficial attribute of the in-process quality control of a product throughout the manufactur-ing process. Any anticounterfeiting scheme must not detract from or STERILITY
interfere with the cautionary statements.
淘儿歌网
Under no circumstances would advertising such as company Sterility Tests—Preparations for injection meet the requirements names, logos, or product names be permitted to appear on the top under Sterility Tests 〈71〉.
(circle) surface of any ferrule or cap overal.
(Official February 1, 2009)
CONSTITUTED SOLUTIONS
Packaging and Storage
Dry solids from which constituted solutions are prepared for in-jection bear titles of the form [DRUG] for Injection. Becau the The volume of injection in single-do containers provides the dosage f
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orms are constituted at the time of u by the health care amount specified for parenteral administration at one time and in no practitioner, tests and standards pertaining to the solution as consti-ca is more than sufficient to permit the withdrawal and adminis-tuted for administration are not included in the individual mono-tration of 1 L.
graphs on sterile dry solids or liquid concentrates. However, in the Preparations intended for intraspinal, intracisternal, or peridural interest of assuring the quality of injection preparations as they are administration are packaged only in single-do containers.
actually administered, the following nondestructive tests are pro-Unless otherwi specified in the individual monograph, a multi-vided for demonstrating the suitability of constituted solutions when ple-do container contains a volume of Injection sufficient to per-they are prepared just prior to u.
mit the withdrawal of not more than 30 mL.
Completeness and Clarity of Solution—Constitute the solution The following injections are exempt from the 1-L restriction of as directed in the labeling supplied by the manufacturer for the ster-the foregoing requirements relating to packaging:ile dry dosage form.
1.Injections packaged for extravascular u as irrigation solu-A:The solid dissolves completely, leaving no visible residue tions or peritoneal dialysis solutions as undissolved matter.
2.Injections packaged for intravascular u as parenteral nutri-B:The constituted solution is not significantly less clear than tion or as replacement or substitution fluid to be administered
an equal volume of the diluent or of Purified Water contained in a continuously during hemofiltration
similar vesl and examined similarly.
Particulate Matter—Constitute the solution as directed in the form: the solution is esntially free from particles of foreign matter labeling supplied by the manufacturer for the sterile dry dosage that can be obrved on visual inspection.
