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Ascor L 500®
Ascorbic Acid for Injection, U.S.P.
500mg/mL, 50mL
Pharmacy Bulk Package
(No preservative added)
McGuff
Pharmaceuticals NDC 67157-101-50
Expiration
Dating: 18 months
Storage: 2-8oC
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 1) 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 2)
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. |
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Our
Ascor L 500®,
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.
Ascor L 500®
Package Insert
Material Data Safety Sheet for Ascor L
500®
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