PDF4PRO ⚡AMP

Modern search engine that looking for books and documents around the web

Example: marketing

1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …

1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT ANDVALIDATIONC hange to read:INTRODUCTIONP urposeThis chapter provides a comprehensive approach covering items to consider for developing and validating dissolutionprocedures and the accompanying analytical procedures. It addresses the use of automation throughout the test and providesguidance and criteria for validation. It also addresses the treatment of the data generated and the interpretation of acceptancecriteria for immediate- and modified-release solid oral dosage chapter addresses the DEVELOPMENT and validation of DISSOLUTION procedures, with a focus on solid oral dosage of the concepts presented, however, may be applicable to other dosage forms and routes of administration. For productscontaining more than a single active ingredient, develop and validate the method(s) for each active ingredient. (USP 1-Dec-2020)General recommendations are given with the understanding that modifications of the apparatus and procedures as given inUSP general chapters need to be organization of this chapter follows the sequence of actions often performed in the DEVELOPMENT and validation of adissolution test.

In addition to pore size, filter design may affect effective particle size exclusion. (USP 1-Dec-2020) If the drug substance particle size is very small (e.g., micronized or nanoparticles), it can be challenging to find a filter pore size that excludes these small particles.

Fullscreen Download

Tags:

  Development, Size, Particles, And development, Particle size

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Spam in document Broken preview Other abuse

Transcription of 1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …

Documents from same domain

71 〉〉〉〉 STERILITY TESTS

latam-edu.usp.org

of the test. Modify the conditions in order to eliminate the antimicrobial activity, and repeat the Method Suitability Test. This method suitability is performed (a) when the test for sterility has to be carried out on a new product; and (b) whenever there is a change in the experimental conditions of the test.

  Tests, Activity, Antimicrobial, Antimicrobial activity

USP <51> Antimicrobial Effectiveness Testing

latam-edu.usp.org

If the diluted product exhibits antimicrobial properties, specific neutralizers may need to be incorporated into the diluents or the recovery media. The ability of the procedure to measure preservative efficacy may be compromised if the method suitability requires significant dilution (10 −2 or 10 −3) as this will affect the measured recovery

  Testing, Effectiveness, Antimicrobial, Efficacy, Usp lt 51 gt antimicrobial effectiveness testing

1664 〉〉〉〉 ASSESSMENT OF DRUG PRODUCT …

latam-edu.usp.org

administration ports, overwraps, adminstration accessories, labels, cardboard boxes, and shrink wrap. A Primary Packaging Component is in direct contact or may come into direct contact with the product (e.g., IV bag). A Secondary Packaging Component is in direct contact with a primary packaging component and may provide additional protection

  Packaging, Shrink

659 PACKAGING AND STORAGE REQUIREMENTS

latam-edu.usp.org

Ancillary component:A component or entity that may come into contact with a Tertiary packaging component during the distribution, storage, and/or transportation of the packaged article (e.g., pallets, skids, and shrink wrap).

  Packaging, Shrink

1151 PHARMACEUTICAL DOSAGE FORMS

latam-edu.usp.org

Bioavailability (See also In Vitro and In Vivo Evaluation of Dosage Forms á1088ñ and Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability, Bioequivalence, and Dissolution á1090ñ.)Bioavailability is influenced by factors such as the

  Form, Solid, Dosage, Dosage forms

Module 08 USP 1115 Bioburden Control of Non-Sterile …

latam-edu.usp.org

Unlike aseptic processing for which facility requirements are generally uniform in specification and performance, nonsterile product manufacturing environments typically involve diverse products and microbial contamination control requirements. In general, liquid, cream, or ointment products require a greater level of

  Product, Control, Sterile, Aseptic, Bioburden, Bioburden control of non sterile

USP <71> Sterility Tests - United States Pharmacopeia

latam-edu.usp.org

The view from USP <1211> Sterilization and Sterility Assurance of Compendial Articles : 6 ... For products containing a mercurial preservative that cannot be tested by the ... Used for sterility testing of viscous products and for devices having tubes with small lumen.

  Product, Tests, Assurance, Sterility, Sterility assurance, Usp lt 71 gt sterility tests

1117 MICROBIOLOGICAL BEST LABORATORY PRACTICES

latam-edu.usp.org

Whenever possible, sampling equipment should be loaded with its microbiological recovery media in the environment that is to be sampled. All testing in laboratories used for critical testing procedures, such as sterility testing of final dosage forms, bulk product, seed

  Microbiological, Sampling

STERILIZATION OF COMPENDIAL ARTICLES

latam-edu.usp.org

For steam and dry heat, the D-value is a function of temperature. In gas sterilization (ethylene oxide, ClO , or O ), D-values are a function of the chemical concentration, relative humidity, and temperature. Similarly, for liquid chemical sterilization the D-value is a function of the temperature and sterilant concentration.

  Steam, Sterilization

660 〉〉 CONTAINERS—GLASS

latam-edu.usp.org

glass containers will raise the hydrolytic resistance from a moderate to a high level, changing the classification of the glass to Type II. The following recommendations can be made as to the suitability of the glass type for containers for pharmaceutical products, based on the tests for hydrolytic resistance.

  Glass, Container, Containers glass

Related documents

Analytical Method Validation Parameters: An Updated Review

globalresearchonline.net

Analytical method development aids to understand the critical process parameters and to minimize their influence on accuracy and ... linearity, range and robustness. Method validation ensures that the selective method will give reproducible, reliable, and consistent ... particle size and rising temperature, altering the eluent or

  Development, Methods, Validation, Size, Particles, Method development, Particle size, Method validation

2.9.31. PARTICLE SIZE ANALYSIS BY LASER LIGHT DIFFRACTION

www.uspbpep.com

DEVELOPMENT OF THE METHOD Traditionally, the measurement of particle size using laser diffraction has been limited to particles in the range of approximately 0.1 µm to 3 mm. Because of recent advances inlensandequipmentdesign, newer instrumentsarecapable of exceeding this range routinely. With the validation report

  Development, Methods, Validation, Size, Particles, Particle size

GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …

www.who.int

90 Analytical method validation ... 1.4 126 The analytical method should be validated by research and development before being ... 148 particle size. 149 150 2.5 The results of analytical procedures should be accurate, legible, contemporaneous, 151 ...

  Development, Methods, Validation, Size, Particles, Particle size, Method validation

GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …

www.who.int

1.2 154 The manufacturer should demonstrate (through validation) that the analytical procedure is 155 suitable for its intended purpose. 156 157 1.3 Analytical methods, whether or not they indicate stability, should be validated. 158 159 1.4 The analytical method should be validated by research and development before being

  Development, Guidelines, Methods, Validation, Appendix, Guidelines on validation appendix 4

Related search queries

Method validation, Method development, Method, Particle size, Development, Validation, GUIDELINES ON VALIDATION APPENDIX 4