37 Questions
What is the ideal percentage range of solids in the frozen plug?
2-25%
Which type of salts are recommended for providing uniform crystal size, color, and texture in sterile products?
Monobasic and dibasic sodium phosphates
What issue is commonly observed when using sodium chloride alone in sterile products?
Crusty and crumbly appearance
What is the main purpose of long-acting parenteral drug formulations?
Simulate continuous i.v. infusion
Which approach is commonly used to control the rate of drug absorption in dissolution-controlled depot formulations?
Formation of drug salts with low solubility
How does particle size contribute to slow dissolution in long-acting formulations?
Large crystals dissolve more slowly
Why are stabilizers, such as antioxidants, added to certain preparations?
To stabilize the pH of the product
Which of the following is true about ophthalmic solutions used in larger quantities?
They are similar to large-volume parenteral solutions
Why are freeze-dried products typically aqueous?
For sublimation during the drying process
What is a crucial consideration for formulations of freeze-dried products?
Characteristics of the solid residue after drying
Why might substances need to be added to certain freeze-dried products?
To provide desired characteristics to the solid residue
Which characteristic is not a critical concern for ophthalmic solutions?
Absence of pyrogens
What is the typical range for the solids content of parenteral suspensions?
0.5 - 5%
Why is the property of thixotropy sometimes utilized in oleaginous suspensions?
To improve syringeability
What is the main challenge in formulating parenteral emulsions?
Achieving uniform oil droplets
Why is it important for parenteral emulsions to have uniform oil droplets?
For improved stability during storage
What factor determines the viscosity of parenteral suspensions?
Nature of the vehicle and amount of solids
Which product has been stabilized with lecithin as mentioned in the text?
A natural vitamin K1 emulsion
What type of glass provides the greatest chemical resistance according to the text?
Type I glass
Which test is performed on ground, sized glass particles according to the text?
Powdered Glass test
What type of glass is classified as providing the least chemical resistance?
NP glass
What is the purpose of using amber glass according to the text?
To filter out ultraviolet rays
Why are single-dose containers designed to be opened only once according to the text?
To prevent contamination
When might Types II and III glass be preferred over Type I for a product?
When the product contains a non-aqueous vehicle
What is the purpose of process control in the manufacture of sterile products?
To make various tests, readings, and observations throughout the manufacturing process
Why is it necessary to perform microbial load tests on incoming stock for sterile products?
To determine the number and types of microorganisms present
What is a key component of production control for sterile products?
Performing sterility tests
In the context of sterile products, what role does quality control play in the manufacturing process?
It encompasses tests on incoming stock, manufacturing, and finished products
What distinguishes process control from production control in the manufacture of sterile products?
Production control includes observing manufacturing process throughout
Why are leak tests, clarity tests, and sterility tests specifically mentioned as part of sterile product manufacturing?
To verify product quality and safety standards
What is the primary purpose of conducting microbial load tests on incoming stock for sterile products?
To assess the number and types of microorganisms present
Why is it crucial to perform a sterility test for sterile products?
To confirm the absence of viable microorganisms
What does process control involve in the manufacture of sterile products?
Making observations and measurements throughout the manufacturing process
In the context of sterile products, why might a clarity test be necessary?
To assess the visual appearance of the product
Which testing method is specifically mentioned as part of incoming stock control for sterile products?
Performing a microbial load test
What role does production control play in the manufacture of sterile products?
Performing final assays and tests on the product
Why are leak tests significant in the manufacturing of sterile products?
To ensure container integrity and prevent contamination
Test your knowledge on the preparation of sterile products, including the use of buffers, additives, and stabilizers. This quiz covers topics such as ophthalmic solutions, large-volume parenteral, and characteristics of pharmaceutical products.
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