Atropine MPID 2 2025-05-13

MPID NO. 2 (6505-31-017-0350)

PGC 42850

MEDICAL PROCUREMENT ITEM DESCRIPTION

NUMBER

DATE

13 May 2025

NATIONAL STOCK NO.

ITEM IDENTIFICATION

6505-31-017-0350

ATROPINE INJECTION, Automatic,
2 mg Atropine Sulfate per 0.7 mL

1. SCOPE. This Medical Procurement Item Description covers Rafa’s Atropine Injection,2mg (NDA No. 212319), in a pressure-activated automatic injector (auto- injector) suitable for rapid intramuscular administration. 2.

SALIENT CHARACTERISTICS

The product will be provided in accordance with the current specifications as included in NDA No. 212319 at time of delivery.
2.1 Medication. Atropine Injection, 2 mg, shall meet the individual NDA requirements. Each individual ingredient in the formula shall be adjusted depending on the total volume to be delivered. The volume range shall be

0.66 mL to 0.8 mL. The volume shall be the total amount delivered during the injection process and shall be measured by gravimetric means

2.1.1 Assay. The amount of Atropine in Rafa’s 2mg autoinjector shall be 95.0-105.0% at release and 93.0-107.0% during shelf life in accordance with approved NDA No. 212319. The amount of phenol which is a preservative in the formulation shall be 90.0-105.0 at release and 70.0-105.0% during shelf life.
All ingredients used in the formulation shall comply with compendial standards (USP/NF) in accordance with the approved NDA no. 212319.

2.1.2 pH. The pH of the injection (solution) shall be from 4.1 to 4.5 when tested at 25o C, in accordance with the approved NDA No. 212319.

2.1.3 Clarity and color. At time of release, the solution color should not be darker than a color standard at 420 nm. Upon release, the product should be clear. The solution shall meet the current USP particulate matter limits for injectables and shall be virtually free from undissolved or visible particulate matter when examined.
2.2

Auto-injector.

2.2.1 Shall be a pressure-activated auto-injector suitable for use in rapid intramuscular administration of the contained medication. Shall be designed to operate in an ambient temperature range of 39.2oF (4oC) to 104oF (40oC), when tested as specified in the approved NDA No. 212319.

2.2.2 Shall be a cylindrically shaped, smoothly formed, spring operated, automatic injection device, weighing a maximum of 20 grams, with an overall length not exceeding 100 mm and a maximum diameter of the unit itself of 14 mm, with the maximum diameter of the finger grip on the yellow safety of 13.0 mm and a minimum of 12.0 mm.
2.2.3 Shall be suitable for use in rapid intramuscular selfadministration of the contained medication by untrained personnel.