|
Introduction
The labeled potency and osmolarity of Magnesium Chloride for Injection has
received some attention recently. While no one disputes the advantages
of using Magnesium Chloride for injection, there has been concern about how
the vial of Magnesium Chloride is labeled, and what amount of Magnesium
Chloride is given if the patient receives the normal dosage required by the
American College of Advancement in Medicine's protocol. This special
bulletin will help answer questions about the labeling of Magnesium Chloride
and it's osmotic pressure.
Background
Magnesium Chloride for Injection is actually derived from Magnesium Chloride
Hexahydrate 200mg/mL (MgCl26H20)
as is stated in the description on the label. Magnesium Chloride Hexahydrate
is a significantly heavier molecule than Anhydrous Magnesium Chloride. Since
the Hexahydrate molecule is used in the manufacturing of Magnesium Chloride
Injection we have different osmolarities, potencies and dosages when
compared to a Magnesium Chloride Injection made from Anhydrous material.
Magnesium Chloride Hexahydrate is used in the manufacturing of Magnesium
Chloride for Injection for several reasons. Magnesium Chloride Hexahydrate
is more stable (than Magnesium Chloride) which allows itself to be weighed
more accurately. Further, the Hexahydrate form of Magnesium Chloride
dissolves much more readily in solution than does Anhydrous Magnesium
Chloride. Once Magnesium Chloride Hexahydrate is dissolved into Sterile
Water for Injection U.S.P. there is no distinction between Magnesium
Chloride Hexahydrate or Magnesium Chloride as a raw material. Without the
addition of the Hexahydrate molecule, Magnesium Chloride would not be able
to be manufactured within the strict limits that are required of injectable
products.
Discussion
The possibility of manufacturing a Magnesium Chloride Injection which
actually contains 200mg of Magnesium Chloride per mL does exist. However, it
has been found that this product crystallizes and therefore, its stability
is affected. The true potency of Magnesium Chloride is reduced because
Magnesium Chloride for Injection contains 200mg per mL of Magnesium Chloride
Hexahydrate. When considering the value of the ratio between Magnesium
Chloride and Magnesium Chloride Hexahydrate molecules, one would have to use
2.135mL of Magnesium Chloride for Injection to actually obtain 200mg of
Magnesium Chloride. The osmolarity of Magnesium Chloride Hexahydrate is
2.951 milliosmoles per mL. This is not the same as Anhydrous Magnesium
Chloride.
Summary
1.
Magnesium Chloride for Injection is actually Magnesium Chloride Hexahydrate
200mg per mL.
2.
The use of Anhydrous Magnesium Chloride as a raw material for an injectable
is not satisfactory. Magnesium Chloride Hexahydrate is the preferred raw
material for manufacturing.
3.
It takes 2.135mL of Magnesium Chloride for Injection to equal 200mg
Magnesium Chloride.
4. The
osmolarity of Magnesium Chloride (MgCl26H20)
for Injection is 2.951 milliosmoles per milliliter.
5. Magnesium
Chloride for Injection is available from THE McGUFF COMPANY, INC.
The McGuff Company
More Than Just Sales and Service
We're Involved!
|