PHR8805

Pregabalin

certified reference material, pharmaceutical secondary standard

• Synonym(s): (S)-3-(Aminomethyl)-5-methylhexanoic acid, (S)-Pregabalin, (S)-3-(Aminomethyl)-5-methylhexanoic acid, CI-1008, PD-144723
• Empirical Formula (Hill Notation): C₈H₁₇NO₂
• CAS Number: 148553-50-8
• Molecular Weight: 159.23
• MDL number: MFCD00917044
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to EP Y0001805; traceable to USP 1559618
• API family: pregabalin
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• application(s): pharmaceutical
• SMILES string: OC(C[C@@H](CN)CC(C)C)=O
• InChI: 1S/C8H17NO2/c1-6(2)3-7(5-9)4-8(10)11/h6-7H,3-5,9H2,1-2H3,(H,10,11)/t7-/m0/s1
• Inchi Key: AYXYPKUFHZROOJ-ZETCQYMHSA-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

Biochem/physiol Actions

Pregabalin is a lipophilic GABA analog/ligand at α2δ subunit of voltage-dependent Ca2+ channels. Pregabalin is an anticonvulsant, anxiolytic analgesic used to treat peripheral neuropathic pain and fibromyalgia.

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.

To see an example of a Certificate of Analysis for this material enter LRAA6959(changes by product) in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS08,GHS07
• signalword: Warning
• hcodes: H336,H361
• pcodes: P202 - P261 - P271 - P280 - P304 + P340 + P312 - P308 + P313
• Hazard Classifications: Repr. 2 - STOT SE 3
• target_organs: Central nervous system
• Storage Class: 13 - Non Combustible Solids
• wgk_germany: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable