Type of Posting: Revision Bulletin
Posting Date: 14–Mar–2008
In accordance with the Rules and Procedures of the Council of Experts, this Revision Bulletin revises the limits for Fosinopril related compound A, Benzothiadiazine related compound A, any other individual impurity and total impurities under the Related compounds test in accordance with FDA approved manufacturers for this product as mentioned in Table 1.
This Revision Bulletin is official as of March 14, 2008. Official text will appear in the Second Supplement to USP 31–NF 26.
Please direct questions to Dr. Sujatha Ramakrishna, Scientific Liaison to the Monograph Development—Cardiovascular Expert Committee (+1-301-816-8349 or sxr@usp.org).
(See revised limits for related compounds in the table below)
Change to read:
Related compounds–
Table 1
Component |
Relative Retention |
Relative Response |
Limit (%) |
---|---|---|---|
Benzothiadiazine related compound A |
0.81 (relative to hydrochlorothiazide) |
1.0 |
|
Fosinopril related compound A |
0.72 (relative to Fosinopril) |
1.2 |
|
Chlorothiazide |
0.90 (relative to hydrochlorothiazide) |
1.7 |
NMT 0.3 |
Any other individual impurity |
— |
— |
|
Total of all impurities |
— |
— |
|