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Merck
CN

PHR8526

Supelco

NEIPA-D5

new

certified reference material, pharmaceutical secondary standard

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grade

certified reference material
pharmaceutical secondary standard

Quality Level

200

Agency

(Not traceable to any primary pharmacopeia standard)

CofA

current certificate can be downloaded

packaging

pkg of 1.2 mL

concentration

1 mg/mL in methanol

application(s)

pharmaceutical

storage temp.

-10 to -25°C

Related Categories

General description

Deutero-N-Nitrosoethylisopropylamine (NEIPA-d5 /NIPEA-d5) is a Certified Reference Material (CRM) to be used as internal standard for liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS) assays Each of our stable isotope labeled CRMs are rigorously tested for stability and isotopic purity.

Many nitrosamine impurities are known to be carcinogenic and of high concern for pharmaceutical development and production. Regulatory agencies such as FDA, EMA and ICH have applied strict regulatory guidelines for the control of these impurities to ensure patient safety.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP 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.

Signal Word

Danger

Hazard Classifications

Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1

Target Organs

Eyes,Central nervous system

Storage Class Code

3 - Flammable liquids

WGK

WGK 3

Flash Point(F)

49.5 °F - closed cup

Flash Point(C)

9.7 °C - closed cup

Regulatory Information

危险化学品
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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