Prior to mounting the specimens on the plate, they may be compressed to thin uniform films by exposing them to temperatures of about under high pressures 15, psi or more. Other olefin ingredients that are most frequently used are butene, hexene, and propylene. Test Solution—Use the Purified Water extract. The absorbance values so obtained are less than 0. Factors such as plastic composition, processing and cleaning procedures, contacting media, inks, adhesives, absorption, adsorption and permeability of preservatives, and con- USP 37 ditions of storage may also affect the suitability of a plastic for a specific use. The tests and specifications provided in this section to characterize PET resins and bottles apply also to PET copolymer resins and to bottles fabricated from them. Adjust with 1 N acetic acid or 6 N ammonium hydroxide to a pH between 3.
Plastic containers intended for packaging products prepared for parenteral use to the thermogram of USP High-Density Polyethylene RS, similarly determined. including Beckman Instruments, Inc., Harbor Blvd., Fullerton, CA. Expert plastic container testing services ensure compliance with USP in Plastic Packaging Systems for Pharmaceutical Use 〈〉.
For more information on the scope of, applicability of, and other topics related to the 〈〉 suite of. equivalent to that of USP Cyclic Olefin Polymer RS or USP Cyclic Olefin Co.
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Fill a glass bottle having the same capacity as that of the test bottles with the corresponding solvent, fit the bottle with an impervious seal, such as aluminum foil, and apply a closure. Test all other plastics as directed under Physicochemical Tests in the section Test Methods.
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Revised USP General Chapter ContainersPlastics ECA Academy
Standards are provided in this chapter for the identification and characterization of the different types of plastic, and the test procedures are provided at the end of the chapter. Plastics may contain other substances such as residues from the polymerization process, plasticizers, stabilizers, antioxidants, pigments, and lubricants.
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|Blank—Use Purified Water where a blank is specified in the tests that follow.
Adjust with 1 N acetic acid or 6 N ammonium hydroxide to a pH between 3. Heavy Metals and Nonvolatile Residue—Prepare extracts of specimens for these tests as directed for Sample Preparation in the section Physicochemical Tests under Test Methods, except that for each Examples of Natural Materials. Test all other plastics as directed under Physicochemical Tests in the section Test Methods.
The revised USP General Chapter > (Containers - Plastics) and new General Chapters and will become official on May.
USP Plastic Containers AMRI
Systems are used to package therapeutic products (pharmaceuticals, biologics, dietary supplements and devices). Such sys- tems and their associated.
Add this document to collection s. PETG resins are high molecular weight polymers prepared by the condensation of ethylene glycol with dimethyl terephthalate or terephthalic acid and 15 to 34 mole percent of 1,4-cyclohexanedimethanol.
Examples of Natural Materials. Materials that do not meet the requirements of the in vitro tests are not suitable for containers for drug products.
Hunt, Ph. Plastic containers intended for packaging products prepared for parenteral use meet the requirements for Biological Tests and Physicochemical Tests in the section Test Methods. Treat a
Usp 661 containers plastics inc
|Other properties that may affect the suitability of polypropylene used in containers for packaging drugs are the following: oxygen and moisture permeability, modulus of elasticity, melt flow index, environmental stress crack resistance, and degree of crystallinity after molding.
Low-density polyethylene has a density between 0. High-density polyethylene has a density between 0. Where stability studies have been performed to establish the expiration date of a particular liquid oral dosage form in a bottle meeting the requirements set forth herein for either PET or PETG bottles, any other PET or PETG bottle meeting these requirements may be similarly used to package such a dosage form, provided that the appropriate stability programs are expanded to include the alternative bottle in order to ensure that the identity, strength, quality, and purity of the dosage form are maintained throughout the expiration period.
The corrected spectrum of the specimen exhibits major absorption bands only at the same wavelengths as the spectrum of USP Low-Density Polyethylene RS. All polyethylene components are subject to testing by IR spectroscopy and differential scanning calorimetry.
USP is a set of analytical standards defined by the U.S. Pharmacopeia (USP) to ensure safety of pharmaceutical products packaged in plastic containers. USP >, Containers – Plastics, Polypropylene Container, Complete (C).
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Test Options/Variations. C USP Polypropylene Container –.
Remove the test bottles with the Extracting Media samples and the glass bottles with the Extracting Media blanks, and store them at room temperature. Add this document to saved.
The thermogram of the specimen is similar to the thermogram of USP Low-Density Polyethylene RS, similarly determined, and the temperature of the endotherm melt in the thermogram of the specimen does not differ from that of the USP Reference Standard by more than 8. Upload document Create flashcards. Description optional. No plastic class designation is assigned to these materials.
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|All polyethylene components are subject to testing by IR spectroscopy and differential scanning calorimetry. Nonvolatile Residue—Transfer, in suitable portions, Physicochemical Tests The following tests, designed to determine physical and chemical properties of plastics and their extracts, are based on the extraction of the plastic material, and it is essential that the designated amount of the plastic be used.
The corrected spectrum of the specimen exhibits major absorption bands only at the same wavelengths as the spectrum of USP High-Density Polyethylene RS. The requirements in this section are to be met when dry solid and liquid oral dosage forms are to be packaged in a container defined by this section. Other olefin ingredients that are most frequently used are butene, hexene, and propylene.
Components that meet the requirements of the in vitro tests are not required to undergo further testing.