Inside USP: Metrology and USP Dissolution - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Inside USP: Metrology and USP Dissolution
The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.


Pharmaceutical Technology
Volume 3, Issue 32

8. P. Nithyanandan et al., "Evaluation of the Sensitivity of USP Prednisone Tablets to Dissolved Gas in the Dissolution Medium Using USP Apparatus 2," Dissolution Technol. 13 (3), 15–18 (2006).

9. J. Eaton et al., "Perturbation Study of Dissolution Apparatus Variables—A Design of Experiment Approach," Dissolution Technol. 14 (1), 20–26 (2007).

10. M.R. Liddell et al., "Evaluation of Glass Dissolution Vessel Dimensions and Irregularities," Dissolution Technol. 14 (2),
28–33 (2007).

11. W.W. Hauck et al., "Proposed Change to Acceptance Criteria for Dissolution Performance Verification Testing," Pharm. Forum 33 (3), 574–579 (2007). Reprinted in: Dissolution Technol. 14 (3), 8–12 (2007).

12. W.W. Hauck et al., "Reliability and Reproducibility of Vertical Diffusion Cells for Determining Release Rates from Semisolid Dosage Forms," Pharm. Res. 24 (11), 2018–2024 (2007).

13. M. Liddell et al., "Dissolution Testing Variability: Effect of Using Vessels from Different Commercial Sources," Am. Pharm. Rev. 10 (6), 122–128 (2007).

14. R.G. Manning et al., "Dissolution Testing and Metrological Measurement of Quality for Solid Oral Dosage Forms," Pharm. Technol. 31 (5), 68–74 (2007).

15. G. Deng et al., "Frequency-domain Vibration Measurement and Analysis in Dissolution Testing," poster presented at the 2007 Annual AAPSMeeting (San Diego, CA).

16. International Bureau of Weights and Measures et al., International Vocabulary of Basic and General Terms in Metrology, Second Ed., ISO (Geneva, Switzerland, 1993), p. 47.

17. 21 USC 501(b). Federal Food, Drug, and Cosmetic Act.

18. ISO, Standard 5725 Accuracy (Trueness and Precision) of Measurement Methods and Results, Parts 1–6, ISO (Geneva, Switzerland, 1994).

19. FDA, "ORA Laboratory Procedure. Assuring the Quality of Test Results. ORA-Lab.5.9," 2007, available at http://www.fda. gov/ora/science_ref/lm/vol2/secion/5_09.pdf, accessed Jan. 29, 2008.

20. P. Nithyanandan et al., "Dissolution Variability: Comparison of Commercial Dosage Forms with US Pharmacopeia Lot P Prednisone Reference Standard Tablets," AAPS PharmSciTech., in press (2008).

21. Z. Gao et al., "Gauge Repeatability and Reproducibility for Accessing Variability during Dissolution Testing: A Technical Note," AAPS PharmSciTech. 8 (4), Art. 82 (2007).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
20%
To all process for new products only
13%
To select process for new products only
24%
To select processes for both new and legacy products
20%
Do not use QbD
22%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>

Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Inadequate Access to Medicines Puts EU at Risk
FDA Offers Insight on QbD for Modified-Release Products
Global Biosimilars Market to Reach $2.445 Billion in 2013
Adapting to Change
AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways
FindPharma Custom Search
Source: Pharmaceutical Technology,
Click here