Metoprolol Tartrate

Metoprolol Tartrate has demonstrated efficacy in managing hypertension, angina, and other cardiovascular conditions while maintaining a high level of safety and tolerability in its use.

General Properties and Specifications of Metoprolol Tartrate:
Appearance: White to almost white powder to crystal.
Assay: 98% minimum.
Melting Point: 120C to 124C.
Boiling Point: 399C.
Solubility: Soluble in water, methanol and chloroform.
Storage: Room temperature in tight, light-resistant containers. Refrigeration preferred. Short term shipping may be ambient.

Metoprolol Tartrate USP Grade Specifications:
(C15H25NO3 )2-C4H6O6 684.81
2-Propanol, 1-[4-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]-, (±)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (2:1) (salt);
(±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol l-(+)-tartrate (2:1) (salt)
1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt CAS 56392-17-7
UNII: W5S57Y3A5L
UNII: GEB06NHM23

DEFINITION
Metoprolol Tartrate contains NLT 98.0% and NMT 102.0% of metoprolol tartrate [(C15H25NO3 )2 · C4H6O6 ], calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test.
Optical Rotation, Specific Rotation:
Sample solution: 20 mg/mL in water
Acceptance criteria: +6.5° to +10.5° (t = 20°)
pH: 6.0–7.0 in 100 mg/mL of Metoprolol Tartrate in water
Loss on Drying: Dry a sample in a vacuum at 60C for 4 h. Acceptance criteria: NMT 0.5%

Metoprolol Tartrate BP Ph Eur Grade Specifications:
C34H56N2O12 --- 685 CAS 56392-17-7

DEFINITION
Bis[(2RS)-1-[4-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2-ol] (2R,3R)-2,3-dihydroxybutanedioate.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, crystalline powder or colourless crystals.
Solubility: Very soluble in water, freely soluble in ethanol (96 per cent).
It shows polymorphism.

IDENTIFICATION
A. Specific optical rotation.
B. Infrared absorption spectrophotometry.

TESTS
Solution S: Dissolve 0.500 g in carbon dioxide-free water and dilute to 25.0 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
pH: 6.0 to 7.0 for solution S.
Specific optical rotation: + 7.0 to + 10.0 (dried substance), determined on solution S.
Impurities M, N, O: To pass the test by Thin-layer chromatography.
Related substances: To pass the test by Liquid chromatography.