Magnesium Chloride Injection, USP
200mg/ml, 50mL (Multiple Dose Vial)
McGuff
Pharmaceuticals NDC 67157-102-50
Expiration
Dating: 2 Years
Storage: Room
Temperature (ref. USP)
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
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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
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Magnesium Chloride for Injection is
actually Magnesium Chloride Hexahydrate 200mg per mL.
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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.
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It takes 2.135mL of Magnesium
Chloride for Injection to equal 200mg Magnesium Chloride.
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The osmolarity of Magnesium Chloride
(MgCl26H20) for Injection is 2.951 milliosmoles per milliliter.
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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.
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Magnesium Chloride for Injection is
available from McGuff Pharmaceuticals, Inc.
Magnesium Chloride Package Insert
Magnesium Chloride Material
Safety Data Sheet
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