Pregabalin Impurity Reference Standard

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Guangzhou Dreampharm Biotechnology Co.,Ltd

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

6/10

Product Information

  • Indication:Not for clinical use; intended only for analytical testing, quality control, and research and development.
  • Specification:mg
  • Dosage Form:Others
  • Route of Administration:Oral
  • Shelf Life:2 years
  • Storage:Sealed
  • Place of Origin:China
  • Qualification:Chinese GMP

Description

Pregabalin Impurity Reference Standard

This product is a high-purity impurity reference standard related to Pregabalin, intended strictly for pharmaceutical R&D, analytical testing, impurity profiling, method development, validation, and quality control. It is not for clinical, therapeutic, or human use.

Typical Impurity Types (examples include but are not limited to):

  • Pregabalin EP Impurity A

  • Pregabalin EP Impurity B

  • Pregabalin EP Impurity C

  • Pregabalin EP Impurity D

  • Pregabalin USP Related Compounds

  • Other structurally related impurities of Pregabalin

Key Features:

  • High-purity impurity reference standard (typically ≥95–98% by HPLC)

  • Supplied as solid powder in sealed glass vials

  • Suitable for impurity analysis using HPLC, LC-MS, and related techniques

  • Certificate of Analysis (COA) and characterization data available

Intended Use:

  • Identification and quantification of Pregabalin-related impurities

  • Analytical method development and validation

  • Stability studies and regulatory submission support

Storage:
Store at 2–8 °C, protected from light and moisture. Reseal immediately after use.


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