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PHR1825

Supelco

Olanzapine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Olanzapine, 2-Methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3-b][1,5]benzodiazepine

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About This Item

Empirical Formula (Hill Notation):
C17H20N4S
CAS Number:
Molecular Weight:
312.43
Beilstein:
7655141
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24
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grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 1060
traceable to Ph. Eur. Y0001370
traceable to USP 1478301

API family

olanzapine

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

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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. Olanzapine is an atypical antipsychotic drug, widely used for the treatment of acute schizophrenia and psychotic conditions.

Application

Olanzapine may be used as a secondary pharma standard for the determination of the analyte in pharmaceutical formulations using high-performance liquid chromatography and spectrophotometric technique.
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.

Analysis Note

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

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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0272 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Skull and crossbones

Signal Word

Danger

Hazard Statements

Hazard Classifications

Acute Tox. 3 Oral - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3


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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