The specifications for pregabalin raw material typically include details regarding its chemical composition physical properties and quality standards Here are some general specifications you might find for pregabalin raw material
1 Chemical Name Pregabalin S3aminomethyl5methylhexanoic acid
2 Molecular Formula C8H17NO2
3 Molecular Weight Approximately 15923 gmol
4 Appearance White to offwhite crystalline powder
5 Melting Point Approximately 194197C
6 Solubility Freely soluble in water soluble in methanol slightly soluble in ethanol practically insoluble in acetone and hexane
7 Purity Typically 98 HPLC
8 Identification Should match the reference standard
9 Residual Solvents Complies with relevant regulations eg USP EP
10 Heavy Metals 10 ppm
11 Loss on Drying 05
12 Assay HPLC 98
These specifications ensure that the raw material meets certain standards of purity and quality suitable for pharmaceutical manufacturing Its important to note that specific details may vary depending on the manufacturer and regulatory requirements of the country or region where it is produced or used