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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.

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