Norepinephrine Bitartrate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₈H₁₁NO₃ · C₄H₆O₆ · H₂O 337.28

C₈H₁₁NO₃ · C₄H₆O₆ 319.27

1,2-Benzenediol, 4-(2-amino-1-hydroxyethyl)-, (R)-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt), monohydrate;

(–)-α-(Aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt), monohydrate CAS RN®: 108341-18-0; UNII: IFY5PE3ZRW.

Anhydrous CAS RN®: 51-40-1; UNII: ZW81GF408B.

1 DEFINITION

Norepinephrine Bitartrate contains NLT 97.0% and NMT 102.0% of C₈H₁₁NO₃ · C₄H₆O₆, calculated on the anhydrous basis.

2 IDENTIFICATION

2.1 A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

2.2 B. Procedure

Sample solution: 5 mg/mL in water

Analysis: Add 1 drop of ferric chloride TS to 2 mL of Sample solution.

Acceptance criteria: An intensely green color develops.

Change to read:

2.3 C. Procedure

Sample solution: 0.1 mg/mL

Analysis: Add 1.0 mL of 0.10 N iodine to 10 mL of the Sample solution. Allow to stand for 5 min, and add 2.0 mL of 0.10 N sodium thiosulfate.

Acceptance criteria: The solution is colorless, or has at most a slight pink or slight violet color (epinephrine and isoproterenol at the same pH, about 3.5, give a strong red-brown or violet color).

3 ASSAY

3.1 Procedure

Sample solution: Dissolve 500 mg of Norepinephrine Bitartrate in 20 mL of glacial acetic acid, warming slightly if necessary to effect solution.

Analysis: Add 2 drops of crystal violet TS to the Sample solution, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction (see Titrimetry 〈541〉). Each mL of 0.1 N perchloric acid is equivalent to 31.93 mg of C₈H₁₁NO₃ · C₄H₆O₆.

Acceptance criteria: 97.0%–102.0% on the anhydrous basis

4 IMPURITIES

Inorganic Impurities

4.1 Residue on Ignition 〈281〉

NMT 0.1%, from 200 mg

4.2 Organic Impurities

Procedure: Limit of Arterenone

Sample solution: 2 mg/mL in water

Analysis: Determine the absorptivity of the Sample solution (see Ultraviolet-Visible Spectroscopy 〈857〉) at 310 nm.

Acceptance criteria: NMT 0.2

5 SPECIFIC TESTS

Optical Rotation, Specific Rotation 〈781S〉: −10° to −12°

Sample solution: 50 mg/mL in water

Water Determination, Method I 〈921〉: 4.5%–5.8%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers. Store at controlled room temperature.

USP Reference Standards 〈11〉

USP Norepinephrine Bitartrate RS