Analytical Services

A broad range of analytical services for complex research needs.
We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds. We also perform stability analysis of drug products and active ingredient (APIs) as per ICH, quality control testing and release as per cGMP requirements.
We support extensive structural chemistry services for small and large molecules. Equipped with one of the best infrastructures in India for Analytical services, We at Monvi Laboratories PVT LTD are well positioned to meet the needs of complex analytical challenges.


Analytical Method Development:

A wide range of chromatographic separation techniques (HPLC, UPLC, GC, GFC and IC) and detection techniques (UV, ELSD, CAD, RI, FID etc...) are used to to meet different types of compounds.
Robust analytical method is one of the keys to quality product development and faster regulatory approval. At Monvi, we develop product specific analytical methods, which are best suitable for intended use of application by applying DOE to analytical methods.
The Analytical Services team has expertise in developing analytical methods for:
    Related impurities
    Chiral purity
    Residual solvents
    In-vitro dissolution
    Wet chemical methods
    Molecular weight determination for large biomolecules by SFC

Analytical Method Validation:

Method validations are carried out as per latest regulatory guidelines for assay, related impurities, chiral purity, residual solvents, in-vitro dissolution, and wet chemistry methods.
At Monvi, Analytical method validations are executed in alignment with stringent SOP, which is based on ICH Q2 guidelines and in adherence to cGMP & GLP requirements.
Validation experimentation includes:
    Forced degradation studies
    Quantitation limit/Detection limit
    Stability of analyte in solution
    Robustness studies
    System suitability
Good documentation practices are followed throughout the process and an exhaustive and scientifically documented validation report is provided to the customers.

Method Transfer

Ensure successful method transfer to our client manufacturing sites

Structural Characterization

Isolation of impurities and purification of compounds using Preparative HPLC
Impurity and degradation product identification and structural elucidation
Characterization of API, product, reference standard and other pharmaceutical ingredients

Qualification of reference Standard

Analytical reference standards qualification

Stability Studies

Stability protocol development and program management
Stability Storage, testing and data trending

Regulatory Queries

Compendial testing (USP, EP, BP, JP etc…)
Analytical Method Equivalency Testing’s, Partition Coefficient etc…

Forced Degragadation

Forced Degradations at the method development stage provides us useful information about drug product characteristics and also establishing stability indicating behaviour of analytical method.
Forced degradation studies include exposure of analyte to harsh hydrolytic, oxidative, photolytic, thermal and humidity conditions.
Determine the degradation pathways and elucidate the structure of degradation products

Chiral Purity

Enantiomeric Separation by Normal HPLC and GC


Proficiency in carrying out Assay and Dissolution by HPLC and by UV-VIS Spectrometer of finished Dosage forms.
USP-1 and USP-2 Dissolution tester
Dissolution (IR, ER and MR)

Contact with our scientific team !

We are at your disposal for any questions


It is our great pleasure to you with our experience and to advise our knowledge

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