A comprehensive portfolio of Pharmaceutical Reference Standards and Impurity Standards designed for API release testing, finished product quality control, stability studies, and regulatory submissions. Each standard is supplied with a full Certificate of Analysis under our ISO/IEC 17025 accredited quality management system, ensuring unbroken traceability to USP, EP, BP, and JP primary pharmacopoeial reference materials.
Accreditation
ISO/IEC 17025
Compendial Traceability
USP / EP / BP / JP
Grade
Pharma Reference
Documentation
Full COA Included
Specifications & Capabilities
Product Category
Pharma Reference Standard
Purity Range
≥ 98.0% – ≥ 99.9%
Impurity Standards
Related Compounds A–K
Compendial Monographs
USP / EP / BP / JP / IP
Pack Sizes
25 mg – 5 g (custom)
Storage
As specified on COA
Applications
- API assay and potency testing per USP/EP/BP monographs
- Identification of known and unknown impurities by HPLC/GC
- Method validation and system suitability testing
- Stability-indicating method development and forced degradation studies
- Finished product quality control and batch release testing
- Regulatory dossier preparation and ANDA/DMF submissions
ISO/IEC 17025
NABL Accredited
Cold‑Chain Shipping
15+ Countries Served
New Delhi · Est. 2013