Tolterodine EP Impurity F(Tartrate)

• Product Information

• Product Code: T036006B

• English Name: Tolterodine EP Impurity F(Tartrate)

• English Alias: (S)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-methylphenol (2R,3R)-2,3-dihydroxysuccinate

• CAS No.：873551-03-2

• Molecular Formula: C??H??NO·C?H?O? (tartrate form)

• Molecular Weight: 475.58 (total, 325.49+150.09)

• Advantages

• High-Purity Reference Standard: As a reference standard for Tolterodine EP Impurity F (tartrate), its structure is confirmed by NMR, MS, and elemental analysis with ≥99.0% purity (HPLC), stable at 2-8°C in the dark for 24 months.

• Regulatory Compliance: Meets EP requirements for impurity reference standards, ensuring high batch-to-batch consistency for impurity control in drug R&D and production.

• Applications

• Quality Control: Used for HPLC detection of Impurity F in Tolterodine API and formulations, controlling content ≤0.1% according to EP standards.

• Analytical Method Validation: Serves as a reference standard to develop and validate detection methods for Impurity F in Tolterodine, evaluating method specificity and sensitivity.

• Stability Studies: Tracks the formation of Impurity F in Tolterodine stability tests, providing data for storage conditions and shelf life.

• Background Description

• Tolterodine is an anticholinergic drug used for treating overactive bladder. Impurity F may arise from residual raw materials, reaction by-products, or degradation during synthesis or formulation. As a specific impurity listed in EP, control of Impurity F is a key part of Tolterodine's quality system, as its presence may affect drug safety and efficacy.

• Research Status

• Detection Technology: HPLC-UV with a C18 column (4.6×250mm, 5μm), mobile phase methanol-phosphate buffer (60:40, v/v), detection at 220nm, with LOQ of 0.05%.

• Formation Mechanism: Impurity F may originate from alkylation side reactions of phenolic hydroxyl groups in Tolterodine synthesis or amination reactions due to residual isopropylamine; optimizing reaction temperature and purification processes reduces its formation.

• Regulatory Requirements: EP specifies an impurity limit of ≤0.1% for Impurity F in Tolterodine, driving the use of this reference standard in pharmaceutical quality control.

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E-mail: anna@molcoo.com

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NOTE！

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com




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