PHR3607

N-Nitrosodiisopropylamine (NDIPA)

certified reference material, pharmaceutical secondary standard

• Synonym(s): N-Isopropyl-N-nitrosoisopropylamine, DIPNA, NDIP
• Empirical Formula (Hill Notation): C₆H₁₄N₂O
• CAS Number: 601-77-4
• Molecular Weight: 130.19
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to USP 1466663
• form: methanol solution
• CofA: current certificate can be downloaded
• packaging: pkg of 1 mL
• application(s): pharmaceutical
• storage temp.: -10 to -25°C
• InChI: 1S/C6H14N2O/c1-5(2)8(7-9)6(3)4/h5-6H,1-4H3
• InChI key: AUIKJTGFPFLMFP-UHFFFAOYSA-N

Description

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.

Application

N-Nitrosodiisopropylamine (NDIPA) pharmaceutical secondary reference standard is used for determining NDIPA impurity in sartan pharmaceutical products using High-Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).

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.

Solvent

1000 ug/mL solution in methanol

Safety Information

• pictograms: GHS08,GHS07
• signalword: Danger
• hcodes: H302,H350
• pcodes: P202 - P264 - P280 - P301 + P312 - P308 + P313 - P405
• Hazard Classifications: Acute Tox. 4 Oral - Carc. 1B
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable