Quality & Compliance

Every compound we supply undergoes rigorous multi-step analytical characterization — because your regulatory submissions deserve nothing less.

Our Commitment

Analytical Rigor at Every Step

At MYMSYNTHON, quality is not a department — it is embedded into every synthesis and analysis we perform. From raw material selection to final release, each step is governed by strict analytical criteria.

We do not release any compound until it passes our full analytical battery. The purity value on your CoA reflects actual measured data — not specification limits.

Our analytical methods are designed to support ICH Q3A, Q3B, and Q3C guidelines, ensuring that the reference standards we provide can withstand regulatory review anywhere in the world.

HPLC Purity Analysis

Reversed-phase HPLC with UV detection at 210nm and 254nm. Method validated per ICH Q2(R1) guidelines.

NMR Spectroscopy

1H-NMR and 13C-NMR at 400 MHz minimum. Complete structural assignment confirming compound identity.

Mass Spectrometry

High-resolution mass spectrometry (HRMS) for accurate mass confirmation. ESI or APCI ionization depending on compound class.

Melting Point / Physical Data

Where applicable, melting point, specific rotation, and other physical characterization data are provided.

Certificate of Analysis

What Every CoA Contains

Our Certificate of Analysis is designed to be regulatory-ready. Here's exactly what we include.

Product name (IUPAC & common)

Full chemical name and synonym

CAS Registry Number

Chemical Abstracts Service number

Catalogue Number

Internal batch tracking reference

Molecular Formula & Weight

Chemical formula and exact molecular weight

Batch Number

Unique lot identification

Manufacturing Date

Date of synthesis completion

Expiry / Retest Date

Stability-based shelf life

Storage Conditions

Temperature, light, and atmosphere requirements

HPLC Purity

Percentage purity by area normalization

Analytical Method Reference

Method ID and conditions used

Authorised Signatory

Quality release signature

Regulatory Framework

ICH Guideline Compliance

Our impurity reference standards are designed to support submissions under all major ICH impurity guidelines.

ICH Q3A(R2)

Impurities in New Drug Substances

Covers thresholds for identification, qualification, and reporting of impurities in APIs.

ICH Q3B(R2)

Impurities in New Drug Products

Addresses degradation products in finished pharmaceutical formulations.

ICH Q3C(R6)

Residual Solvents

Classification and permitted daily exposure limits for residual solvents.

ICH Q3D(R1)

Elemental Impurities

Risk-based approach to control elemental impurities in drug products.

ICH M7(R1)

Mutagenic Impurities

Assessment and control of DNA reactive (mutagenic) impurities, including nitrosamines.

Quality You Can Rely On

Request a quote or browse our catalog of fully characterized pharmaceutical impurities.

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