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Operant Scientific
Method development, validation, QC, stability

The analytical package, in one lab.

Buyers regularly ask us to run analytical work independently of the manufacturing engagement — either as a second-source method transfer or as an outsourced QC arm. The analytical group operates on the same SOP framework as manufacturing, so results are transferable.

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Method development
HPLC · GC · LC-MS · NMR · XRPD · DSC/TGA · KF
Validation
ICH Q2(R2) — specificity, LoD/LoQ, linearity, robustness
Stability studies
ICH Q1B compliant chambers + photostability
Data transfer
Client-signed at every pull point
Process

Five stages from brief to delivery.

Timelines vary by molecule and scope; the shape below applies to every engagement.

  1. Step 01

    Method scoping

    Impurity profile, matrix, and acceptance criteria defined.

  2. Step 02

    Method development

    Column selection, mobile-phase optimisation, robustness testing.

  3. Step 03

    Validation

    Specificity, LoD/LoQ, linearity, precision, accuracy, robustness.

  4. Step 04

    Transfer

    Site-to-site method transfer with co-validation and comparison stats.

  5. Step 05

    Stability

    Long-term, accelerated, and photostability studies per ICH Q1B.

Equipment & governance

The specific tools, standards, and headcount.

Chromatography

  • HPLC (Agilent/Waters)×12
  • GC-FID / GC-MS×5
  • LC-MS/MS triple quad×2
  • UPLC systems×3

Spectroscopy & thermal

  • NMR 400 MHz×1
  • FTIR×2
  • DSC / TGA×2
  • XRPD×1
  • Karl Fischer titrators×4
Representative case

One example, real numbers.

Recent engagement

Second-source method transfer in six weeks.

European client needed an independent QC lab to co-validate an HPLC assay. Six-week engagement including method transfer, co-validation, and stability pull.

Method
HPLC assay + related
Client
EU speciality pharma
Timeline
6 weeks
Outcome
Co-validated, no re-work
Read the full caseRepresentative case — full attribution under NDA.

Analytical testing — capability deck

A ten-page PDF written by our subject-matter lead for this capability. Delivered by email within one business day, always signed by a director.

  • Full analytical suite (HPLC, GC-MS, LC-MS, NMR, XRPD, DSC/TGA)
  • Method development and ICH Q2(R2) validation
  • ICH Q1B compliant stability chambers with client-signed data

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Other capabilities

Five more under the same QA framework.

All capabilities

CDMO & CMO

Full-service contract development and manufacturing under one QA framework.

API manufacturing

cGMP API and intermediates production at pilot and commercial scale.

Route scouting

8-14 week engagements that produce 2-3 viable synthetic routes with scorecards.

Technology transfer

Site-to-site and stage-to-stage transfers with signed transfer protocols.

R&D and innovation

Small-molecule discovery, process R&D, and green-chemistry alternatives on every route.

Ready when you are

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