Question

Which of the following vehicles (not required to be sterile, but must be pyrogen free) is intended to be used in the manufacture of injectable products to be sterilized after preparation?

• A. Purified Water
• B. Water for Injection USP
• C. Sterile Water for Injection USP
• D. Bacteriostatic Water for Injection USP

Answer 1

The Correct Option is B

To determine which vehicle is intended to be used in the manufacture of injectable products to be sterilized after preparation, we need to understand the specifications and uses of each option provided:

1. Purified Water: It is used for cleaning and preparing non-sterile products. It is not typically used for injectables because it does not meet the stringent requirements needed for injectable products.
2. Water for Injection USP: This water is specifically prepared for use in the production of injectable products. It must be pyrogen-free and is used in the manufacture of products that will be sterilized after preparation. The requirement for pyrogen-free status makes it suitable for injectables, which are sterilized post-preparation.
3. Sterile Water for Injection USP: This is used directly for the dilution of already sterilized products. It is sterile but its primary use is for aseptic preparations, not the initial manufacturing of products to be sterilized later.
4. Bacteriostatic Water for Injection USP: This contains antimicrobial agents, making it suitable for multi-dose vials or when repeated withdrawals are necessary, but not typically for the initial preparation of products that require further sterilization.

Conclusion: The correct answer is Water for Injection USP, as it is the vehicle intended for use in the manufacture of injectable products that are to be sterilized after preparation. It meets the required specifications of being pyrogen-free and suitable for pharmaceutical manufacturing processes.