Pharma R&D Services
Pharma R&D Services
About R&D Services
Pharmapure not only offers high-quality reference standards but also delivers a
comprehensive range of services driven by our expertise in the pharmaceutical industry.
Our offerings are continuously updated to meet market demands and leverage the latest
available technologies.
Method of Analysis Development and validation
We are developing analytical methods for
analyzing pharmaceutical products and
dietary supplements.
We are validating analytical methods to
ensure reliability and compliance with
industry standards.
ICH Stability Studies
Long-term and accelerated studies were
conducted to determine the shelf life and
proper storage conditions for
pharmaceuticals according to ICH
guidelines
Dissolution Profiles
Memic the dissolution behavior in the
human body by dissolving the drug in a
solution over time
Stress Studies (Forced Degradation)
Identifying and analyzing unknown
compounds in pharmaceutical products
Nitrosamines Testing by LC-MS/MS and GC-MS/MS
Detection and quantification of nitrosamine
impurities in pharmaceuticals using
advanced liquid chromatography-mass
spectrometry (LC-MS/MS) and gas
chromatography-mass spectrometry (GC
MS/MS)
Metals Testing by ICPMS (ICH Q3D)
Analysis of trace metal impurities in drugs
using Inductively Coupled Plasma Mass
Spectrometry (ICPMS) to comply with ICH
Q3D guidelines
Cleaning Validation
Ensuring that manufacturing equipment is
cleaned and sanitized with an approved
cleaning procedure to prevent
contamination between production
batches
QC Testing of Batches
Quality control tests are conducted
on production batches to ensure
they meet specified standards
before release
Leachable and Extractables for Packaging Materials
Testing packaging materials for
substances that might leach into
the product and affect its safety or
efficacy.
Cross-Contamination Studies
Investigating and preventing
contamination between different drug
products during manufacturing
Pharmaceutical Formulation Development
Assisting in the development and
optimization of pharmaceutical product
formulations
Pharmacopeial tests
Assay
Related Substance
Particle size