CERTIFICATE OF ANALYSIS
|
PRODUCT NAME: Pregabalin EP Impurity D
|
|
Date of Mfg: Sample COA
|
RETEST DATE: Sample COA
|
|
Catalogue Number
|
PRG-011
|
|
|
Lot Number
|
Sample COA
|
|
Batch Quantity
|
Sample COA
|
|
CAS Number
|
4118-51-8
|
|
Mol. Formula
|
C11 H14 O3
|
|
Molecular Wt
|
194.23 g/mol
|
|
Long Term Storage Condition
|
2-8 °C for long term storage
|
Handling instruction
|
Sample COA
|
|
IUPAC
|
1-Methylethyl (2RS)-2-hydroxy-2-phenylacetate
|
|
Chemical Name
|
Pregabalin EP Impurity D
|
|
Synonyms
|
Isopropyl DL-Mandelate; (+/-)-Mandelic acid isopropyl ester; Isopropyl 2-hydroxy-2-phenylacetate
|
| Test |
Results
|
| Appearance |
White to Off-White Low-Melting Solid
|
| Identification by 1H NMR |
Sample COA
|
| Identification By IR |
Sample COA
|
| Mass (ESI) |
Sample COA
|
| Purity |
98%+
|
| Wt. Loss by TGA |
Sample COA
|
| % Potency |
Sample COA
|
| Solubility |
Chloroform (Slightly), Methanol (Sparingly)
|
| QC Release Date |
Sample COA
|
| Attachments |
Sample COA
|
|
Note: This material can be used as a referance standard and is for research purpose ONLY and not for human consumption
|
This is Sample COA
|