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Merck
CN

PHR8952

Mirtazapine

certified reference material, pharmaceutical secondary standard

Synonym(s):

Mirtazapine, 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine

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About This Item

Empirical Formula (Hill Notation):
C17H19N3
CAS Number:
85650-52-8
Molecular Weight:
265.35
UNSPSC Code:
41116107
MDL number:
MFCD00865427
NACRES:
NA.24

Key Documents

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Product Name

Mirtazapine, certified reference material, pharmaceutical secondary standard

InChI key

RONZAEMNMFQXRA-UHFFFAOYSA-N

InChI

1S/C17H19N3/c1-19-9-10-20-16(12-19)15-7-3-2-5-13(15)11-14-6-4-8-18-17(14)20/h2-8,16H,9-12H2,1H3

SMILES string

CN1CCN2C(C1)c3ccccc3Cc4cccnc24

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000705
traceable to USP 1444279

API family

mirtazapine

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

application(s)

pharmaceutical

storage temp.

-10 to -25°C

Quality Level

300

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Biochem/physiol Actions

Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA). Mirtazapine agonizes selective adrenergic and serotonergic receptors so that both NE release and 5-HT1A mediated serotonergic signaling are increased.

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Mirtazapine can be used as a reference standard for the determination of the analyte in pharmaceutical formulation, tablets and human plasma using HPLC method.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302,H336

Hazard Classifications

Acute Tox. 4 Oral - STOT SE 3

target_organs

Central nervous system

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

新产品
This item has

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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