Pregabalin



With characteristics like unmatched standard and superior grade, our range of product is the finest one obtainable in Mumbai(India). Our warehouse is installed with advanced machines and all required amenities ensuring safe storage of diverse kinds of products requiring different storage temperatures and conditions.

 

Details

  • Article - 1206-103

  • Batch No. - PG/023/16

  • Mfg. Date - 12/2016

  • Exp. Date - 11/2021

 

Remark : In the opinion of the undersigned the sample tested to above is of standard quantity of In House Specification and complies I.P. Specification with respect to the above mentioned test

 

Abstract From Factory Record

  • Analysed by - Q.C. Chemist

  • Approved by - Q . C. Manager

 

Disclaimer of liability : The information in this SDS was obtained from sources which we believe are reliable. However, the information is provided without any warranty, express or implied, regarding its correctness. The conditions or methods of handling, storage, use or disposal of the product are beyond our control and may be beyond our knowledge. For this and other reasons, we do not assume responsibility and expressly disclaim liability for loss, damage or expense arising out of or in anyway connected with the handling, storage, use or disposal of the product. Buyer should ascertain & verify the data and analyse on its own before using the product. This data I information is the indication and not final. Products covered by valid patents in a country are not offered & I or supplied there. The customer is responsible for verification of the patent position. Product are not offered in the countries where they are covered under Patent. However, ultimate responsibility remains of the customer.



Analytical Report

Test Specifications Results
Description White to Off White powder White powder
Solubility Sparingly soluble in water Complies
Identification IR Spectrum: The infrared sbsorption spectrumof the sample should concordant with that of the spectrum of WS of product Complies
Loss On Drying NMT 0.5 % w/w 0.28% w/w
Specific Optical Rotation (On Anhydrous Basis) +10.0 Deg to +12.0 Deg +10.29 Deg
Sulphated Ash NMT 0.1% 0.049% w/w
Heavy Metals NMT 20 ppm < 20 ppm
Enantiomeric purity The area of peak due to R-Pregabalin in NMT 0.5% the area of the S-Pregabalin 0
Related Substances(By HPLC) Lactum impurities : NMT 0.5% Not Detected
Individual impurity: NMT 0.5%

0.298%

Total Impurities: NMT 1.0% 0.569%
Assay By HPLC 98% to 102% w/w 99.58% w/w