Pharmaceutical Services and Solutions | Globesynth Pharma Tech

Your Trusted Impurity Partner

Manufacturer of Impurity Standards Innovating Regulatory Science with Precision & Excellence.
Serving 1,000+ Global Clients

Specialists in Impurity & Advanced Chemical Synthesis

API Impurities • Process • Degradation • Potential Impurities & Metabolites Custom Synthesis • Chiral
• Peptides • Nucleic Acids • Discovery Chemistry Delivering Tailored Solutions Across Pharma, Biotech & Life Sciences

Quality control and pharmaceutical production

Science-Driven. Compliance-Focused. Globally Trusted

Mechanism-Based Impurity Development with Scalable Chemistry Driven by Design-of-Experiments (DoE), Defined CQAs & CPPs, and Regulatory-Compliant Data Systems From Discovery to Commercialization — Seamlessly Executed

6,000+ Impurity Standards Ready for Immediate Supply

High-Purity API Impurities, Standards & Intermediates (>95% Purity)
Reliable Inventory with Fast Turnaround & Global Reach
Precision. Availability. Regulatory Confidence — Delivered

Laboratory backdrop — capabilities overview

Genotoxic & Nitrosamine Capabilities

50+ genotoxic nitroso impurities
mg to gram scale supply
NDMA, NDEA, NDSRIs
Available up to gram scale
Genotoxic impurity risk assessment
Custom GTI synthesis

CBN-Approved & Controlled Substances

Licensed narcotic & controlled substances
mg to gram scale supply
70+ CBN-approved APIs & impurities
Fast post-clearance dispatch
Complete regulatory documentation

About Us

Best Pharmaceutical Testing & Research Center

Globesynth Pharma Tech, an ISO-certified Contract Research Organization (CRO), started in 2018, has its own manufacturing facility in Salem, Tamil Nadu, India.

Globesynth Pharma Tech is specialized in the Synthesis of API Impurities, Process Impurities, Degradation Impurities, Potential Impurities, Building Blocks, metabolites of active ingredients and excipients, Medicinal Discovery Chemistry, Custom Synthesis, Materials Chemistry, Library Design and Synthesis, Chiral Synthesis, Peptide Synthesis, Nucleic Acids Chemistry and Process Chemistry. We are a group of highly skilled chemists with backgrounds in higher education who provide a variety of customized synthesis services to the pharmaceutical, agricultural biotechnology and veterinary industries.

Highlights

Why Choose Globesynth Pharma Tech?

Regulatory-grade expertise and capabilities that set the standard

Regulatory-Grade Impurity & Reference Standard Expertise

API Impurity Synthesis (EP, USP, IP, BP)

High-purity (>95%) pharmacopoeial and non-pharmacopoeial impurities synthesized to meet global regulatory expectations.

6,000+ API Impurities, Standards & Intermediates

Extensive in-house inventory supporting pharmaceutical, biotech, academic, and regulatory institutions.

Trusted Supplier to Leading Institutions

Partner to EDQM, NIPER, IPC, leading research organizations, and 1,000+ clients worldwide.

Global Partnerships & Distribution

Supplying across Asia, Europe, and global markets with full regulatory compliance.

Advanced Unknown Impurity & Degradation Support

Comprehensive Impurity Profiling

Process, degradation, metabolite, peptide, and nitrosamine impurities (NDSRIs).

Forced Degradation & Enrichment

Controlled generation from 0.01% to >98% purity.

Isolation & Characterization

Prep-HPLC, normal phase methods, advanced spectroscopy.

Structure Elucidation Reports (SER)

¹H / ¹³C NMR
2D NMR (COSY, HSQC, HMBC, NOESY)
LC-MS/MS, IR & HPLC

Precision Analytical & Regulatory Support

Retention Time (RT)
Relative Retention Time (RRT)
Response Factor (RF)
COA with full spectral data
ICH-aligned impurity support

Genotoxic & Nitrosamine Capabilities

50+ genotoxic nitroso impurities
NDMA, NDEA, NDSRIs
Available up to gram scale
Genotoxic impurity risk assessment
Custom GTI synthesis

CBN-Approved & Controlled Substances

Licensed narcotic & controlled substances
mg to gram scale supply
70+ CBN-approved APIs & impurities
Fast post-clearance dispatch
Complete regulatory documentation

Our Expertises

Custom Synthesis Services

At Globesynth Pharma Tech, we are proud to offer a comprehensive range of services tailored to meet the diverse needs of the pharmaceuticals, research...

Pharmaceutical Reference Standards

A pharmaceutical reference standard is a substance or material that has been thoroughly characterized and established as a standard of identity, purity...

Traceable Working Standards

A traceable working standards is a highly pure, well-characterized chemical reference material used in pharmaceuticals (and other industries) to identify...

Impurity Standards

Impurity standards in the pharmaceutical industry refer to reference materials or substances that are used to identify, quantify, and characterize impurities present...

Isolation and Characterization of Unknown Impurities

Isolation and characterization of unknown impurities involve separating them from a main substance (often using preparative HPLC) and then identifying their...

Metabolites

Metabolite impurities are a critical consideration in the field of pharmaceutical development and drug manufacturing. They play a significant role in...