• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Science & Research

  • Print
  • Share
  • E-mail

Volume IV - 3.8 Document Change History

DFS Pyramid Logo

Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-03
VERSION NO.: 1.7

Section 3 - Drug Analysis

EFFECTIVE DATE: 10-01-03REVISED: 02-14-13
Version
No.
Status
(I, R, C)
Date
Approved
Location of Change HistoryName & Title
AuthorApproving Official

1.3

R

09-01-05

Table of Contents – Added 3.6 Appendix 2; added 3.8
Revised Section 3.1, 3.2 B., 3.3 B. 5., 3.4.1, 3.4.2.1 A., B. & C., 3.4.2.2, 3.4.2.2 I. B., 3.4.2.2 II. B., 3.4.2.2 III., 3.4.2.3 III. B. & IV. B., 3.4.2.4 I. A. & II., 3.4.3, 3.5, 3.6 Appendix 1 & 3; added 3.6 Appendix 2.

LMEB

LMEB

1.4

R

01-17-08

Version 1.4 changes:
3.1, 3rd para, last sentence – Deleted "altogether"
3.2, 3rd para - Changed "diethyl" to "diethylene"
3.3 A. 1st para – added "or pressure" after high performance
3.3 B. 1., 4th para – revised
3.3 B. 6. – revised
3.3 B. 8. – updated 5th web address
3.3 C. 2. – revised
3.4.2.3 B. 3. – deleted
3.4.2.3 III. C. 2. – added (FID)
3.4.2.4 I. C. 3. – revised 5th sentence
3.5 – deleted 1st para
3.7 – revised 3.3.2, 3.4.2.2. (I) 1. & 5., 3.4.2.2 (II) 4., 3.4.2.3. (III) 1. & 4., 3.4.2.3. (IV) 2.,
3.4.2.4 (I).1.

LMEB

LMEB

1.5

R

02-02-10

Version 1.5 changes:
3.3.B. – updated web links in 5., 7., & 8.; added last sentence to 8.
3.4.2.4 I. A. III. B. – revised
3.4.2.4 I. B. 1. – revised
3.4.2.4 I. B. 2. - deleted
3.5 – updated web links
Footer – updated web link

LMEB

LMEB

1.6

R

 02-06-12

Version 1.6 changes:
3.3 B. 2. – changed “testing” to “review” in second sentence
3.3 C. 5. – deleted
3.4 – added last sentence
3.4.2 I.. A. – added USP reference to bullet 7; deleted bullet 10; added bullets 13 and 14
3.4.2.I. B. 2. – deleted Disintegration Test from bullet 2
3.4.2.I. B. 3. – “6” changed to “8” in bullets
3.4.2.2 II. A. III. – added D. and E.
3.4.2.3.III B. 1. – changed “Suspension” to “Solution” in 1.; added Method 11 b to bullet
3.4.2.3 III B. 2. – revised
3.4.2.3 IV. A. 2. – added 7.; added “Gradient” to C.4.
3.4.2.3.IV. B.1. – “Suspensions” changed to “Solution”; B change to A, part 5.1 in second bullet; 5.1 deleted in third bullet
3.4.2.4. I. C – deleted 2.
3.4.2.4.II. 16. – changed VIII to VII
Appendix 1 I. – deleted 2.3; changed Apparatus 2 to Apparatus 1 in 3.2; changed Suspension to Solution in 5. ; changed 6.1 B. to HPLC; deleted 6.6, 6.7, and 6.8; 7.1 changed to FTIR; 7.6 spelling corrected and changed to FID; deleted 7.10; added “loss on” to 8.5; added <281> to 8.6; 8.12 changed to color from limit test; 9.2 changed from UV to HPLC; added 10. 
Appendix 2 I. – added 4. and changed GC product and test method
3.7 Answer Key 3.3 3.- answer revised and deleted 4., 5., and 6.
3.7 Answer Key 3.4.1 1. – first and second sentence revised
3.7 Answer Key 3.4.2.1 – 3. deleted sentences 3., 4., 5., and the last sentence
3.7 Answer Key 3.4.2.4.(I) –deleted 2.

LMEB

LMEB

1.7

R

02-14-13

Version 1.7 changes: Header – Division of Field Science changed to Office of Regulatory Science
7. – Divison of Field Science changed to Office of Regulatory Science

LMEB

LMEB