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PACKAGING OF PHARMACEUTICALS, IDEAL REQUIREMENTS, CRITERIA, PACKAGING TYPES, CLOSURES, CONTAINERS ,PACKAGING MATERIALS, CLOSURES, CONTAIN

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PACKAGING K. VENKATA RAMANA REDDY ASSOCIATE PROFESSOR

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INDEX Definition. Objectives. Ideal Qualities of Packaging Materials. Criteria For Selecting Packaging Materials. Types of Container Used As Primary Packaging For Liquid Orals. Components of Packaging. Properties of Packaging Materials. Packaging Types Different Types of Primary Packaging. Different Types of Secondary Packaging. Primary Packaging Materials. Types of Glass Containers. Materials Used For Making of Closures. Approaches to package design. Symbols used in packaging. Factor influencing the choice of package. Properties of packaging materials. The types of tests carried out for Medical Device Packages

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Packaging is the science art and technology of enclosing or protecting products for distribution storage sale and use. It is an economical means of providing presentationprotectionidentification informationcontainmentconvenience and compliance for a product during storage carriage display and until the product is consumed. Packaging must provide protection against climatic conditions biological physical and chemical hazards and must be economical. The package must ensure adequate stability of the product throughout the shelf life.

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OBJECTIVES OF PACKAGING 4  Physical protection  Barrier protection  Containment or agglomeration  Security  Convenience  Portion control

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Ideal Qualities of a Pharmaceutical Package 1. It should have sufficient mechanical strength so as to withstand handling filling closing and transportation. 2. It should not react with the contents stored in it. 3. It should be of such shape that can be elegant and also the contents can be easily drawn from it. 4.It should not leach alkali in the contents. 5. The container should not support mould growth. 6. The container must bear the heat when it is to be sterilized. 7. The contents of container should not be absorbed by the container. 8. The material used for making the container should be neutral or inert. 9. Any part of the container or closure should not react with each other. 10. Closure should be of non toxic nature and chemically stable with container contents.

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CRITERIA FOR SELECTING PACKAGING MATERIALS Stability Compatibility with the contents Strength of container and the degree of protection required Moisture-proofness Resistance to corrosion by Acids or Alkalis Resistance to grease Protection against salt Resistance to microorganisms Resistance to insects and rodents Resistance to differences in temperature Protection against light fire and pilferage Odor retention and transmission Aesthetic effect Cost Machine suitability of packaging and the filling method.

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Types of container used as primary packaging for liquid orals are: Single dose containers hold the product that are intended for single use. An example of such a container is the glass ampoule. . Multi-dose containers hold a quantity of the material that will be used as two or more doses. An example of this system is the multiple doses vial or the plastic tablet bottle. . Well –closed containers protect the product from contamination with unwanted foreign materials and form loss of contents during use . Airtight containers are impermeable to solids liquids and gases during normal storage and use. If the container is to be opened on more than one occasion it must remain airtight after reclosure . Light – resistant container protect the contents from the effect of radiation at a wave length between 290nm and 150nm.

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For solid dosage forms: Tamper – evident containers are closed containers fitted with a device that irreversibly indicates if the container has been opened. Strip packages have at least one sealed pocket of material with each pocket containing a single dose of the product. The package is made of two layers of film or laminate material. The nature and level of protection which is required by the contained product will affect the composition of these layers. Blister packages are composed of a base layer with cavities called blisters which contain the pharmaceutical product and a lid. This lid is sealed to the base layer by heat pressure or both. They are more rigid than strip packages and are not used for powders or semi-solids. In tropical areas blister packages with an additional aluminium membrane is used which provide greater protection against high humidity. Child Resistant Containers commonly referred to as CRCs are designed to prevent the child accessing the potentially hazardous product

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Containers for semi solid and pressurized products: Semi solid dosage forms like ointments creams etc are packed in metallic collapsible tubes. Plastic containers are also used for the packaging of creams. . Pressurized packages expel the product through a valve. The pressure exerted for the expulsion of the product is an important consideration while selecting the packaging for any products.

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Components of packaging 1. Container: The containers refer in which the product/ medicine is placed enclosed. It is direct contact with drug. 2. Closure: It is tightly packs the container to exclude oxygen carbon dioxide moisture prevents the loss of water and volatile substances from the products. 3. Carton/outer: Which gives secondary protecion against mechanical and other environmental hazards. It is outer covering. Cartoons are made up of cardboard wood pulp etc. 4. Box: In this multiples of products are packed. It provides primary defense against external hazards. The boxes are made up of thick cardboard and wood.

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Properties of packaging materials: Mechanical Properties: The materials used should possess sufficient mechanical strength to withstand while handling filling closing and processing. Typical care is needed during transport storage and also at the time of usage by the consumer especially in case of glass containers. A glass container will have greater strength if all corners are rounded. Physical properties: The material should be impervious to any possible contaminants for example solids liquids gases vapors or microorganisms. The container must be able to withstand heat if the processing includes sterilization. The surface must be capable of clear labeling often difficult for example with plastics. The packaging must have a suitable size thus rubber may presents problems if it perishes. The material must protect from light if necessary that is it must be ultraviolet absorbent. The container must not absorb substances from the products e.g. absorption of water from creams in to cardboard box

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Chemical properties: •The container and the closure should not react together either alone or in the presence of the product. This can occur with certain combination of dissimilar materials. •The product should not react with the container or closure as might happen if alkaline substances are placed in aluminium containers. •Substances must not be extracted from the product such as the loss of bactericides from injection solution to rubber. •The container or closure must not yield substances to the product for example alkali from glass plasticizers from plastics etc. Biological properties: •The material of the container must be able to withstand attack by insects if this hazard is likely to be encountered. The packing should not support mould growth. T he risk is greatest with cellulosic substance and if the use of such materials is unavoidable the attack may be minimized by impregnation

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PACKAGING TYPES  Primary packaging is the material that first envelops the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents. 13

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 Secondary packaging is outside the primary packaging – perhaps used to group primary packages together. This package provide additional protection during warehousing and also provide information about drug product for e.g Leaflets. 14

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 Tertiary packaging is used for bulk handling warehouse storage and transport shipping.The most common form is a palletized unit load that packs tightly into containers. It is outer package of secondary packaging prevents damage to the products.  Examples: Barrel crate container pallets slip sheet 15

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Different types of primary packaging 16  Ampoules  Vials  Containers  Dosing dropper  Closures plastic metal  Syringe  Strip package  Blister packaging

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DIFFERENT TYPES OF SECONDARY PACKAGING 17 • Paper and boards • Cartons • Corrugated fibers • Box manufacture

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PRIMARY PACKAGING MATERIALS 18 GLASS : Glass has been widely used as a drug packaging material. Advantages of glass: It allows easy inspection of the containers contents. It is available in variously shaped containers. Disadvantages of Glass: - It is fragile It is expensive when compared to the price of plastic.

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Glass a. Type-1 borocilicate glass. b. Type -2 treated sodalime glass. c. Type-3 regular sodalime glass. d. Type-4 NP general purpose sodalime glass. e. Colored glass. Type-1: Borocilicate glass Eg: pyrex borosil. Main constituents: Sio2-80 Al203-2 Na2o Cao-6 Type-2: Treated soda lime glass Main constituents: Made of soda lime glass. The surface of which is treated with acidic glass like So2 at Elevated temperature and moisture. Type-3: Regular soda lime glass Main constituents: Sio2 Na2O Cao. Properties: Flakes separate easily many crack due to sudden change of temperature.

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Type-4 NP Non Parenteral glass or general purpose soda lime glass. Uses: Topical use for oral use not for ampoules. Neutral glass Main constituents: Sio2 -72 to 75 B2o3 -7to 10 Na2o -6 to 8 K2o - 0.5 to 2 Bao -2 to 4. Properties: Lower cost than borosilicate they are softer can easily be moulded. Uses: Small vials 25 ml Large transfusion bottles. Colored bottles Main constituents: Glass + iron oxide. Properties: Produce amber color glass Can resist UV Visible radiation from 290-400-450nm

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TUBULAR VIALS 21

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TYPES OF GLASS CONTAINERS 22 BOTTLES:- Used in the dispensary as either amber metric medical bottles or ribbedfluted oval bottles. Available in sizes from 50ml to 500ml. Amber metric medical bottles are used for packaging a wide range of oral medicines. . Ribbed oval bottles attached are used to package various product that should not be taken orally. This includes liniments lotions inhalations and antiseptic solutions.

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AMPOULES One point cut ampoules. Flat Based and Constricted Neck ampoules Flame cut ampoules. Closed ampoules Ampoules with colour break band DROPPER BOTTLES:-  Eye drop and dropper bottles for ear and nasal use are he  xagonal-shaped amber glass container fluted on three sides.  They are fitted with a cap rubber teat and dropper as the closure. The bottles are used at a capacity of 10ml or 20ml. 24

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JARS 25 o Powders and semi-solid preparations are generally packed in wide-mouthed cylindrical jars made of clear or amber glass. o Jars varies from 15ml to 500ml. o Jars are used for packing prepared ointments and pastes. PLASTICS  Used as container for the product and as secondary packaging  Two classes of plastics are used and these are known as thermosets and thermoplastics.

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ADV ANTAGES OF PLASTICS:- oFlexible and not easily broken. oLow density and light in weight. oAre cheap DISADV ANTAGES OF PLASTICS:- They are not as chemically inert as Type -I glass. They are not as impermeable to gas and vapour as glass. They may possess an electrostatic charge which will attract particles. 26

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Used for many types of pack including rigid bottles for tablets and capsules squeezable bottles for eye drops and nasal sprays jars flexible tubes and strip and blister packs. POLY ETHYLENE:  This is used as high and low density polyethylene  Low density polyethylene LDPE is preferred plastic for squeeze bottles.  High density poly ethylene HDPE is less permeable to gases and more resistant to oils chemicals and solvents.  It is widely used in bottles for solid dosage forms. 27

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POLYVINYLCHLORIDE PVC:- Used as rigid packaging material and main component of intravenous bags. POLY PROPYLENE:- It has good resistance to cracking when flexed. Suitable for use in closures tablet containers and intravenous bottles. POLYSTYRENE:- . It is also used for jars for ointments and creams with low water content. 28

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PLASTICCONTAINERS 29

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METALS Metals used such as tin-plated steel mild steel stainless steel tin-free steel and aluminum and its various alloys. Metal is strong opaque and impermeableto moisture gases odors light bacteria etc. It is resistant to high and low temperatures TIN:- Tin is the most chemically inert of all tube metals. It offers good appearance and compatibility with a wide range of products 2 0

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TINPLATE:- Tinplate is basically a steel structure with a thin layer of tin deposited on either one side or both sides gives the steel some protection from corrosion . ALUMINIUM:-  Aluminium lighter in weight and can be easier to shape. The thick rigid closures are used mainly for cans or aerosol containers while the thin flexible material is used primarily for the closure of bottles or thermoforms 2 1

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 Blister packs use a hard temper so that the tablet can be pushed through the material. Tubes can be supplied internally by    Lacquered Wax coated Latex line 2 2

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PLASTIC TUBES Types of plastics Plastics are classified in to 2 groups according to their behavior when heated. Thermoplastic type: On heating they soften to a viscous fluids which hardens again on cooling. Eg: Polyetyline Polypropylene PVC Polystyrene Nylon etc. Thermosetting type: When heated they may become flexible but they do not become liquid usually hard and brittle at room temperature. Eg: Phenol Formaldehyde Urea etc. Flexible plastic tubes in a range of sizes dia. 19 mm to 50 mm dia. and volume up to 300 ml. thickness with 400 - 500 micron. 2 3

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LAMINATED TUBES Multilayer tubes with Aluminum foil / nylon / polyester act as barrier against oxygen moisture aroma loss and provide a glossy surface enhancing printing quality. Transparent stretch polypropylene and PET tubes with dispenser caps are designed  Different caps such as conical flip-top can be custom designed for an aesthetic look. 2 4

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BULK CONTAINERS For bulk drug and active pharmaceutical ingredient packaging bags and drum liners manufactured in a cGMP- compliant environment. LDPE and foil laminate bags and drum liners are custom-produced in a wide range of sizes and constructions .  cGMP-compliant with respect to quality systems complete traceability change control SOPs and pharmaceutical grade housekeeping and are registered in Drug Master File . 2 5

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BULK CONTAINER 2 6

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BLISTER PACK:- 2 7 Blister packs are commonly used as unit dose packaging for pharmaceutical tablets capsules or lozenges  Blister packs consist of two principal components : 1 a formed base web creating the cavity inside which the product fits and 2 the lidding foil for dispensing the product out of the pack.  There are two types of forming the cavity into a base web sheet: thermoforming and cold forming

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Example for cold forming method 2 8

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 Aluminium Foils for Blister Packing  Aluminium Foil suitable for blister packing of Pharmaceutical Products such as Tablet Capsules etc. 2 9

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STRIP PACKAGE:- 3 0  It is commonly used for the packaging of tablets and capsules. A strip package is formed by feeding two webs of a heat sealable flexible film through a heated crimping roller .The product is dropped into the pocket formed before forming the final set of seals. A continuous strip of packets is formed which is cut to the desired number of packets in length.  The materials used for strip package are cellophane polyester polyethylene polypropylene polyvinylchloride.

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Example for strip package 3 1

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CLOSURES 3 2  Closures are the devices by means of which containers can be opened and closed. Proper closing of the container is necessary because  It prevents loss of material by spilling or volatilization.  It avoids contamination of the product from dirt microorganisms or insects.  It prevents deterioration of the product from the effect of the environment such as moisture oxygen or carbon dioxide.

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MATERIALS USED FOR MAKING OF CLOSURES The closures for containers meant for storage of pharmaceutical products are generally made from the following basic materials. Cork Glass Plastic Metal Rubber Aluminium 3 3

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SECONDARY PACKAGING MATERIALS PAPER:- This can be used as a flexible wrap for products or as a closure material for jars. Most paper materials are used with a liner applied either as a laminate or as a coating. 3 4

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PHARMACEUTICAL CORRUGATED FIBERBOARD  Corrugated fiberboard is a paper-based construction material consisting of a fluted corrugated sheet and one or two flat linerboards. It is widely used in the manufacture of corrugated boxes 3 5

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CARTON A carton is a type of suitable for food pharmaceuticalshardware and many other types of products. Foldingcartons are usually combined into a tube at the manufacturer and shipped flat knocked down to the packager. 3 6

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Rubber Natural rubber consists of long chain polymers of isoprene units linked together in the cis portion. Its most important source is the tree Hevea braziliensis from which latex containing 30 to 40 of rubber in colloidal suspension exudes when shallow cuts are made in the bark. A. Butyl rubber: These are co polymer of isobutylene with 1-3 of butadiene. Advantages Permeability to water vapor and air is very low. Water absorption is very low. B. Nitrile rubber Advantages: Oil resistant due to polar nitrile group heat resistant. Disadvantage: Absorption of bactericide and leaching of extractives are considerable. C. Chloroprene rubber These are polymers of 1:4 choprene. This rubber is more polar hence oil resistant. Heat stability is good up to 1500c

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D. Silicon rubbers Advantages Heat resistance up to 2500c Extreamly low absorption and permeability of water. Poor tensile strength. Disadvantage: They are very expensive. Aluminum : Advantages: 1. Aluminium is a light metal hence the shipment cost of the product is less. 2. They provide attractiveness of tin at somewhat lower cost. Disadvantages : a. As a result of corrosion process H2 may evolve b. Any substance that react with the oxide coating can cause corrosion. Uses: Aluminum ointment tubes Screw capes . METALS Advantages : a. Metal containers are strong relatively unbreakable opaque. b. Resistance to chemical attack. c. Impervious to water vapor bacteria d. Readily coats a number of metals. Disadvantages This is the most expensive metal among tin lead aluminium iron. b. Currently some eye ointments still package in pure tin ointment tubes.

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: Approaches to package design Physical protection: It should protect from other things like mechanical shock vibration electrostatic discharge compression temperature etc. Information transmission: Packages and labels should communicate how to use transport recycle or dispose of the package or product. With pharmaceuticals food medical and chemical products some types of information are required by governments. Marketing: The packaging and labels can be used by marketers to encourage potential buyers to purchase the product. So product package should be elegant and attractive Convenience: Packages should have features that add convenience in distribution handling display sale opening re-closing use reuse recycling and ease of disposal.

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•Security: Packaging should play an important role in reducing the security risks of shipment. Packages should be made with improved tamper resistance to determine tampering and also should have tamper- evident features to help indicate tampering. Packages should be engineered to help reduce the risks of package pilferage.

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Packaging symbols and Approach to Package design Many types of symbols for package labeling are nationally and internationally standardized. For product certifications trademarks proof of purchase etc. identification code . Fragile This way up Keep away fromsunlight Keep away fromwater 30

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Factor influencing the choice of package It is essential to have a survey about the market the distribution system manufacturing facilities and other considerations before selecting the packaging material. The product: The physical and chemical characteristics of the drug entity the excipients the formulation route of deterioration of the product type of patient baby child teenager adult elderly infants etc must be considered while dealing with the pharmaceutical product. Apart from the properties of drug package style to attract patient and other legal requirements should also be considered during selection. The market: The channel of sale should be considered i.e. where when how and by whom it is to be used or administered e.g. doctor dentist nurse patients etc whether for home trade and/ or export. The quantity per package and follow up sale must all be care fully considered during package design and selection.

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The distribution system: The distribution system should be carefully monitored e.g. conventional wholesale/ retail outlet or direct or selective outlets. Less sophisticated transport systems like mules donkeys camels etc requires additional protection if intermediate storage facilities are non existent. Manufacturing facilities: The stability of the manufacturing facilities should be considered due to new package increased sale improvements in Good Manufacturing Practice revised product new product etc.

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Properties of packaging materials To afford the necessary protection the materials from which the container is to be made must show certain basic properties which can be divided into four groups. Mechanical Properties: The materials used should possess sufficient mechanical strength to withstand while handling filling closing and processing. Typical care is needed during transport storage and also at the time of usage by the consumer especially in case of glass containers. A glass container will have greater strength if all corners are rounded. Physical properties: The material should be impervious to any possible contaminants for example solids liquids gases vapors or microorganisms. The container must be able to withstand heat if the processing includes sterilization.The surface must be capable of clear labeling often difficult for example with plastics. The packaging must have a suitable size thus rubber may presents problems if it perishes.

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The material must protect from light if necessary that is it must be ultraviolet absorbent. The container must not absorb substances from the products e.g. absorption of water from creams in to cardboard box. Chemical properties: The container and the closure should not react together either alone or in the presence of the product. This can occur with certain combination of dissimilar materials.The product should not react with the container or closure as might happen if alkaline substances are placed in aluminium containers.Substances must not be extracted from the product such as the loss of bactericides from injection solution to rubber. The container or closure must not yield substances to the product for example alkali from glass plasticizers from plastics etc. Biological properties: The material of the container must be able to withstand attack by insects if this hazard is likely to be encountered. The packing should not support mould growth. T he risk is greatest with cellulosic substance and if the use of such materials is unavoidable the attack may be minimized by impregnation

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The types of tests carried out for Medical Device Packages • Sterility Testing • Manual handling • Vehicle stacking • Loose-load vibration • Vehicle vibration • Drop test • Compression • Package seal strength testing. Quality Control : Dimensional criteria such as shape volume wall thickness and design tolerances should be defined and monitored. Physical considerations such as water vapor transmission to evaluate seal integrity thermal analysis such as DSC to monitor melting point and glass transitions of plastics and IR scanning to prove identity should be a part of an ongoing quality-control monitoring program. • Chemical composition should also be evaluated by performing the simple but informative USP physicochemical tests using water drug product vehicle and alcohol extractions of plastic components.

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