Common English Abbreviations Used in the Bacterial Endotoxins Test

Bacterial Endotoxin Test (BET)

TAL: Tachypleus Amebocyte Lysate

LAL: Limulus Amebocyte Lysate

BET: Bacterial Endotoxin Test

TRW/LRW: TAL/LAL Reagent Water

RSE: Reference Standard Endotoxin

CSE: Control Standard Endotoxin

λ: In the gel-clot method, λ refers to the labeled sensitivity of the TAL/LAL reagent (EU/mL). In the photometric method, λ refers to the lowest endotoxin concentration on the standard curve.

L: Endotoxin Limit.

The bacterial endotoxin limit of the test product is calculated as L = K/M, and is expressed in EU/mL, EU/mg, or EU/U (activity unit).

K: The maximum acceptable endotoxin dose per kilogram of body weight per hour for humans.

K is expressed as EU/(kg·h). For injections, K = 5 EU/(kg·h); for radiopharmaceutical injections, K = 2.5 EU/(kg·h); and for intrathecal injections, K = 0.2 EU/(kg·h).

M: The maximum dose of an injectable product per kilogram of body weight per hour for humans.

M is expressed as mL/(kg·h), mg/(kg·h), or U/(kg·h). The average human body weight is assumed to be 60 kg. If the injection time is less than 1 hour, it is calculated as 1 hour.

MVD: Maximum Valid Dilution.

where L is the bacterial endotoxin limit of the test product, and C is the concentration of the test solution. When L is expressed in EU/mL, C = 1.0 mL/mL. When L is expressed in EU/mg or EU/U, the unit of C should be mg/mL or U/mL, respectively.

If the test product is a sterile powder for injection or an active pharmaceutical ingredient (API), the MVD is taken as 1, and the minimum valid concentration of the test product is calculated as:

MVC: Minimum Valid Concentration.

NC: Negative Control.

NPC: Negative Product Control or Negative Test Product Control.

PC: Positive Control.

PPC: Positive Product Control or Positive Test Product Control.