Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Molecular formula
- C₁₇H₁₉N₃
- Technologies
- Product Families
- Chemical Structure
- Definition
Mirtazapine contains NLT 98.0% and NMT 102.0% of mirtazapine (C₁₇H₁₉N₃), calculated on the anhydrous basis.
Applications & Uses
- Markets
Properties
- Typical Properties
| Value | Units | Test Method / Conditions | |
| Molecular Weight | 265.35 | — | — |
Regulatory & Compliance
- USP Reference Standards
- USP Mirtazapine RS
- USP Mirtazapine Resolution Mixture RS Mirtazapine.
- Impurity A: 1,2,3,4,10,14b-Hexahydro-2- methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2- oxide.
- Impurity B: (2-(4-Methyl-2-phenylpiperazin-1-yl)pyridin- 3-yl)methanol.
- Impurity C: (2-Methyl-3,4,10,14b-tetrahydrobenzo[c] pyrazino[1,2-a]pyrido[3,2-f]azepin-1(2H)-one.
- Impurity D: [NOTE—This impurity may be available either as the free base form or as the hydrochloride salt form.] (ERR 1-Apr-2021) 1,2,3,4,10,14b- Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a] pyrido[2,3-c][2]benzazepine hydrochloride. (ERR 1-Apr-2021)
- Impurity E: 4-Methyl-1-(3-methylpyridin-2-yl)-2- phenylpiperazine. Impurity F: 2-Methyl-1,2,3,4-tetrahydrobenzo[c] pyrazino[1,2-a]pyrido[3,2-f]azepin-10(14bH)-one.
Storage & Handling
- Storage Information
Preserve in tight containers, and store at controlled room temperature.