What It Covers

Scope of Work

Bespoke method development tied to product attributes

Method validation per ICH Q2(R2) — specificity, linearity, accuracy, precision, robustness

Method transfer between sponsor, CDMO and Lunar Labs

Verification of compendial methods (USP / Ph. Eur. / BP)

Dissolution-method development for solid oral dosage forms

Stability-indicating method development with forced-degradation

Identification of unknown peaks and unknown impurities

Cleaning verification methods (swabs, rinsates) and TOC support

How We Do It

Methods & Instrumentation

HPLC / UPLC

Reversed-phase, normal-phase, ion-exchange and HILIC for assay, related substances and content uniformity.

LC-MS / LC-MS/MS

Trace-level impurity quantification, metabolite ID and unknown-peak elucidation.

GC / GC-MS / Headspace

Residual solvents, volatile profiling and structural ID.

ICP-MS

Elemental impurities to ICH Q3D, USP <232>/<233>.

UV-Vis / FTIR

Identity, qualitative comparison and impurity-trace screening.

Dissolution

USP Apparatus 1, 2 and (where in scope) 3/4 with auto-sampling.

Karl Fischer

Coulometric and volumetric water content for solids and liquids.

Wet Chemistry

Titrimetric assays, pH, conductivity, refractive index, optical rotation.

Regulatory Framework

Standards This Work Maps Onto

Methods, documentation and acceptance criteria are designed to align with the standards below. This describes design intent — formal accreditations are listed on the About page.

ICH Q2(R2) — Method Validation

ICH Q3A, Q3B, Q3C, Q3D — Impurities

ICH Q6A — Specifications

USP <1225> / <1226> — Validation and Verification

EU GMP — EudraLex Vol. 4 (where GMP-applicable)

ISO 17025-style traceability of raw data

What You Receive

Typical Deliverables

Method development report with rationale

Method validation protocol and report (ICH Q2)

Method transfer protocol and report

Compendial method verification report

Unknown-peak ID memo with structural proposal

Inspection-ready raw data and audit trail

Who It's For

Sectors We Support

Drug-product and API manufacturers

CDMOs requiring an independent analytical lab

Sponsors needing method validation for IMP

Generic developers reverse-engineering reference products

Nutraceutical brands needing pharma-grade methods

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