Ascor L 500®, is McGuff Pharmaceuticals Inc.'s (MPI's) branded formula of Ascorbic Acid Injection, USP.
Ascor L 500® is indicated for use in the prevention and treatment of scurvy. MPI's Ascor L 500® consists of a 50mL pharmacy bulk package of sterile, preservative-free,
pyrogen-free Ascorbic Acid, USP (500 mg/mL) in a solution containing Edetate Disodium (0.025%), Water for Injection (q.s.) and Sodium Bicarbonate for pH adjustment (pH 5.5 to 7.0).
Ascor L 500® is equivalent to American Regent NDC 0517-5050-01 and Bioniche NDC 63286-0118-5 with the exception that American Regent products are stored at controlled room temperature. Storage conditions for Ascorbic Acid Injection are not specified in the U.S.P. (USP31). MPI chose to have its product refrigerated based on:
- a consumer survey that indicated consumer resistance to excessive pressure build up in the vial and high viscosity that caused a prolonged bubble effect of competing products and
- stability study data that suggests retention of product potency over time is enhanced with refrigerated storage.
Refrigeration retards the accumulation of pressure and improves stability of product potency. However, our stability indicating studies also demonstrate that short term storage at room temperature (e.g. during shipment) does not significantly affect the potency of the product.
Ascorbic Acid for Injection U.S.P., fully conforms to the U.S.P. monograph for Ascorbic Acid
Injection. It is made solely from Ascorbic Acid and not with Sodium Ascorbate expressed as an Ascorbic
Acid equivalent.
Some competing Ascorbic Acid No Preservative Injections contain
large amounts (10mg per mL) of Monothioglycerol (a viscous fluid with a slight sulfide odor) as a
stabilizer to inhibit interaction between the Ascorbic Acid and Oxygen. For our Ascorbic Acid Injection,
we have chosen to utilize a trace amount (0.025%) of Edetate Disodium (EDTA.) instead of Monothioglycerol
and have incorporated specific packaging components (stoppers) that inhibit oxygen transfer and product
interactions.
All McGuff Pharmaceuticals Ascorbic Acid products are manufactured from
U.S.P. and N.F. grade raw materials.
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 Ascor L 500® demonstrates our commitment to
these customers and markets.
