2. Below is an excerpt from the package insert of Procainamide HCI for Injection, USP. Answer the following questions. A. Why must the solution pH be between 4 and 6? B. Why is sodium metabisulfite include in the formulation? C. Why is the headspace nitrogen gassed? | DESCRIPTION Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of procainamide hydrochloride in water for injection. Each milliliter of the 2 mL vial contains procainamide hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8 mg added in water for injection. Each milliliter of the 10 mL vial contains procainamide hydrochloride 100 mg; methylparaben 1 mg and sodium metabisulfite 0.8 mg added in water for injection. In both formulations, the solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed. Procainamide Hydrochloride Injection is intended for intravenous or intramuscular administration. Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2- (diethylamino) ethyl] benzamide mono-hydrochloride. It has the following structural formula: *NH2 CONHCH2CH2N(C2H5)2 • HCI M.W. 271.79 *(locus for acetylation to N-acetyl procainamide). It differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol. Procainamide as the free base has a pKa of 9.23; the monohydrochloride is very soluble in water.
2. Below is an excerpt from the package insert of Procainamide HCI for Injection, USP. Answer the following questions. A. Why must the solution pH be between 4 and 6? B. Why is sodium metabisulfite include in the formulation? C. Why is the headspace nitrogen gassed? | DESCRIPTION Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of procainamide hydrochloride in water for injection. Each milliliter of the 2 mL vial contains procainamide hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8 mg added in water for injection. Each milliliter of the 10 mL vial contains procainamide hydrochloride 100 mg; methylparaben 1 mg and sodium metabisulfite 0.8 mg added in water for injection. In both formulations, the solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed. Procainamide Hydrochloride Injection is intended for intravenous or intramuscular administration. Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2- (diethylamino) ethyl] benzamide mono-hydrochloride. It has the following structural formula: *NH2 CONHCH2CH2N(C2H5)2 • HCI M.W. 271.79 *(locus for acetylation to N-acetyl procainamide). It differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol. Procainamide as the free base has a pKa of 9.23; the monohydrochloride is very soluble in water.
Chapter10: Reconstitution Of Powdered Drugs
Section: Chapter Questions
Problem 7.2P
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Question
Please answer parts A, B, and C
![2. Below is an excerpt from the package insert of Procainamide HCI for Injection, USP.
Answer the following questions.
A. Why must the solution pH be between 4 and 6?
B. Why is sodium metabisulfite include in the formulation?
C. Why is the headspace nitrogen gassed? |
DESCRIPTION
Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of procainamide
hydrochloride in water for injection. Each milliliter of the 2 mL vial contains procainamide
hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8 mg added in water for
injection. Each milliliter of the 10 mL vial contains procainamide hydrochloride 100 mg;
methylparaben 1 mg and sodium metabisulfite 0.8 mg added in water for injection. In both
formulations, the solution may contain hydrochloric acid and/or sodium hydroxide for pH
adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed.
Procainamide Hydrochloride Injection is intended for intravenous or intramuscular
administration.
Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2-
(diethylamino) ethyl] benzamide mono-hydrochloride. It has the following structural formula:
*NH2
CONHCH2CH2N(C2H5)2
• HCI
M.W. 271.79
*(locus for acetylation to N-acetyl procainamide).
It differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol.
Procainamide as the free base has a pKa of 9.23; the monohydrochloride is very soluble in water.](/v2/_next/image?url=https%3A%2F%2Fcontent.bartleby.com%2Fqna-images%2Fquestion%2F4f2ba44d-49aa-4749-bcfd-beff7f234665%2F2ff70d0c-b2d1-46b3-84d8-5c7575546bc6%2F21izke3_processed.png&w=3840&q=75)
Transcribed Image Text:2. Below is an excerpt from the package insert of Procainamide HCI for Injection, USP.
Answer the following questions.
A. Why must the solution pH be between 4 and 6?
B. Why is sodium metabisulfite include in the formulation?
C. Why is the headspace nitrogen gassed? |
DESCRIPTION
Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of procainamide
hydrochloride in water for injection. Each milliliter of the 2 mL vial contains procainamide
hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8 mg added in water for
injection. Each milliliter of the 10 mL vial contains procainamide hydrochloride 100 mg;
methylparaben 1 mg and sodium metabisulfite 0.8 mg added in water for injection. In both
formulations, the solution may contain hydrochloric acid and/or sodium hydroxide for pH
adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed.
Procainamide Hydrochloride Injection is intended for intravenous or intramuscular
administration.
Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2-
(diethylamino) ethyl] benzamide mono-hydrochloride. It has the following structural formula:
*NH2
CONHCH2CH2N(C2H5)2
• HCI
M.W. 271.79
*(locus for acetylation to N-acetyl procainamide).
It differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol.
Procainamide as the free base has a pKa of 9.23; the monohydrochloride is very soluble in water.
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