Ascor L 500 (Ascorbic Acid Injection, USP) is a sterile, nonpyrogenic solution of ascorbic acid prepared with the aid of sodium bicarbonate in water for injection.  Ascorbic Acid is an essential water-soluble vitamin.  Ascor L 500 is indicated for injection by the intravenous, intramuscular, and subcutaneous routes.  Each mL contains 500 mg of ascorbic acid, and edetate disodium 0.025% (w/v).  It also contains sodium bicarbonate and may contain sodium hydroxide to aid in preparation and pH adjustment.  The pH is 5.5-7.0. It contains no bacteriostat, antimicrobial agent or added buffer.  It must be protected from light.

The chemical name of Ascorbic Acid is L-ascorbic acid.  The molecular formula is C₆H₈O₆.  It occurs as white or slightly yellow crystals or powder.  It has the following structural formula:

Clinical Pharmacology:

Ascorbic acid (vitamin C) has few strictly pharmacological actions.  Administration in amounts greatly in excess of physiologic requirements causes no demonstrable effects.  The vitamin is an essential coenzyme for collagen formation, tissue repair and synthesis of lipids and proteins.  It acts both as a reducing agent and as an antioxidant and is necessary for many physiologic functions, e.g., metabolism of iron and folic acid, resistance to infection, and preservation of blood vessel integrity.  Signs and symptoms of early vitamin C deficiency include malaise, irritability, arthralgia, hyperkeratosis of hair follicles, nosebleed, and petechial hemorrhages.  Prolonged deficiency leads to clinical scurvy.

Ascorbic acid is normally present in both plasma and cells.  The absorbed vitamin is ubiquitous in all body tissues.  The highest concentrations are found in glandular tissue, the lowest in muscle and stored fat.  Ascorbic acid is partially destroyed and partially excreted by the body.  There is a renal threshold for vitamin C; the vitamin is excreted by the kidney in large amounts only when the plasma concentration exceeds this threshold, which is approximately 1.4 mg/100 mL.  When the body is saturated with ascorbic acid, the plasma concentration will be about the same as that of the renal threshold; if further amounts are then

Material Data Safety Sheet for Ascor L 500^®

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