Magnesium Chloride Injection is indicated for use as an electrolyte
replenisher in magnesium deficiencies. MPI's Magnesium Chloride
Injection consists of a 50mL volume of sterile, pyrogen free Magnesium
Chloride Hexahydrate (200 mg/mL) in a solution containing Sodium
Chloride (9 mg/mL), Benzyl Alcohol (1% as a preservative), and Water
for Injection. The product is used in intravenous admixtures in a
variety of therapies.
This product is equivalent to American Regent NDC 0517-5034-01and Bioniche NDC 62086-134-50
Magnesium Chloride for Injection, USP
Magnesium Chloride for Injection is actually Magnesium Chloride Hexahydrate 200mg/mL (MgCl2 • 6H20) 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.
Background
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 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.
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
- Magnesium Chloride for Injection is actually Magnesium Chloride Hexahydrate (200mg per mL. 200mg/ml, 50mL Multiple Dose Vial)
- 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.
- It takes 2.135mL of Magnesium Chloride for Injection to equal 200mg Magnesium Chloride.
- The osmolarity of Magnesium Chloride (MgCl2 • 6H20) for Injection is 2.951 milliosmoles per milliliter.
- For patient treatment purposes, the attending physician must take into consideration that MPI Magnesium Chloride Injection contains 1.97 mEq of Mg++ per mL of injection.
- Magnesium Chloride for Injection is available from McGuff Pharmaceuticals, Inc.
(NDC 67157-102-50)
- Expiration Dating: 2 Years. Storage: Room Temperature (ref. USP)
McGuff Pharmaceuticals, Inc. is focused
on providing small volume, sterile injectable products to the
physician and hospital markets. Through a unique combination of
technical capabilities, state of the art manufacturing facilities and
strong relationships with distribution partners, MPI fulfils it's
objective of meeting patient and physician needs for high quality,
competitively priced, small volume injectable products. The
introduction of Magnesium Chloride Injection demonstrates our
commitment to these customers and markets.
