PDF4PRO ⚡AMP

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

Example: biology

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.

This chapter addresses the development and validation of dissolution procedures, with a focus on solid oral dosage forms. ... For products containing more than a single active ingredient, develop and validate the method(s) for each active ingredient. (USP 1-Dec-2020) ... (such as dynamic solubility, potentiometric titration, or turbidity ...

Fullscreen Download

Tags:

  Methods, Validation, Dissolution, Titrations

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

STRENGTH AND STABILITY TESTING FOR COMPOUNDED …

www.usp.org

Jan 13, 2014 · Other methods used to test strength include titration, which uses the principles of chemistry, and microbial assays, which are sometimes used to test antibiotics. Titration is based upon a known ... The method validation confirms that the method meets certain criteria. The typical analytical characteristics used in method validation include ...

  Testing, Methods, Validation, Stability, Titrations, Compounded, Method validation, And stability testing for compounded

1400-Fm 9/9/99 7:37 AM Page i CModern Analytical …

gtu.ge

3E.4 Validation 47 3F Protocols 48 3G The Importance of Analytical Methodology 48 3H Key Terms 50 ... 9A.3 Titration Curves 275 9A.4 The Buret 277 ... 9B.3 Titrations in Nonaqueous Solvents 295 9B.4 Representative Method 296 9B.5 Quantitative Applications 298 9B.6 Qualitative Applications 308 9B.7 Characterization Applications 309 9B.8 ...

  Methods, Validation, Titrations

Titration Method Validation - USP

www.usp.org

Method validation of a titration ensures that the selected titration method and parameters will provide a reliable and robust result. Before the method validation, it is necessary to standardize the titrant, in order to achieve accurate results. Method validation for titration should include determination of the specificity, linearity, accuracy,

  Methods, Validation, Titrations, Method validation, Titration method, Titration method validation

Standard Methods for the Examination of Water and …

www.awwa.org

B. Titration Method 2320 ALKALINITY A. Introduction B. Titration Method 2330 CALCIUM CARBONATE SATURATION A. Introduction B. Indices Indicating Tendency of a Water to Precipitate or Dissolve CaCO 3 C. Indices Predicting the Quantity of CaCO 3 That Can Be Precipitated or Dissolved D. Graphical and Computer Methods for CaCO 3 Indices 2340 …

  Standards, Methods, Examination, Titrations, Standard methods for the examination, Titration method

ALKALINE DUSTS 7401

www.cdc.gov

ALKALINE DUSTS: METHOD 7401, Issue 2, dated 15 August 1994 - Page 3 of 4 d. Remove electrodes, rinse them into the titration vessel, and bubble N 2 gas through contents of the titration vessel for 3 to 5 min to remove dissolved CO 2. e. Proceed with the titration to the inflection point. f. Calculate the normality of the stock HCl solution: 9.

  Methods, Alkaline, Dust, Titrations, 4710, Alkaline dusts 7401

Ricerca Preclinical Primer - UC Davis Health

health.ucdavis.edu

Bioanalytical method validation (per analyte, two species) 65 - 80 PK (per study) 10 – 20 MTD / DRF (two species) 100 – 130 Genetic toxicity 85 - 100 Safety pharmacology 135 - 160 28 Day: Rat Dog Monkey 200 – 300 250 – 350 400 – 600 + Candidate API supply + BA Internal standard synthesis + Formulations development

  Methods, Validation, Method validation

DEPARTMENT OF DEFENSE HANDBOOK - UC Davis

www.library.ucdavis.edu

not measurement sensitive mil-hdbk-17-1f volume 1 of 5 17 june 2002 superseding mil-hdbk-17-1e 23 january 1997 department of defense handbook

  Department, Handbook, Department of defense handbook, Defense

Related search queries

AND STABILITY TESTING FOR COMPOUNDED, Titration, Method validation, METHOD, Validation, Titration Method Validation, Titration Method, Standard Methods for the Examination, ALKALINE DUSTS 7401, Department of defense handbook