Question

The LAL test is specifically performed to detect what in parenteral products?

• A. Microbial contamination
• B. Endotoxins
• C. Heavy metals
• D. Preservatives

Hint:

Important pharmaceutical tests:

• \textbf{LAL Test} $\rightarrow$ Detects bacterial endotoxins
• \textbf{Sterility Test} $\rightarrow$ Detects microbial contamination
• \textbf{Pyrogen Test} $\rightarrow$ Detects fever-causing substances

Remember: \textbf{LAL = Endotoxin detection in parenteral products}.

Answer 1

The Correct Option is B

Step 1: Understanding the Concept:
Parenteral products (like injections and infusions) bypass the body's natural defense mechanisms and enter directly into the systemic circulation.
Therefore, they must be completely free from pyrogens, which are fever-inducing substances.
Step 2: Key Approach:
Understand the purpose and biological basis of the LAL (Limulus Amebocyte Lysate) test in pharmaceutical quality control.
Step 3: Detailed Explanation:
Bacterial endotoxins are a specific type of pyrogen found in the outer cell membrane of Gram-negative bacteria.
The LAL test uses an aqueous extract of blood cells (amebocytes) from the Atlantic horseshoe crab (Limulus polyphemus).
When this lysate comes into contact with bacterial endotoxins, it undergoes an enzymatic coagulation reaction.
This specific reaction makes the LAL test highly sensitive and specific for the detection and quantification of bacterial endotoxins.
It does not detect live microbial contamination (which requires sterility testing) or heavy metals.
Step 4: Final Answer:
The LAL test is performed to detect Endotoxins.