What does Pharmaffiliates’ Method Development service include?

Method Development at Pharmaffiliates involves designing analytical procedures and testing them for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit and robustness to suit each stage of drug development. :contentReference[oaicite:1]{index=1}

For which types of samples can methods be developed?

Methods can be developed for APIs, drug products and — as needed — pharmaceutical formulations or containers, depending on the scope defined by the client. :contentReference[oaicite:2]{index=2}

Which analytical techniques are supported under the service?

Pharmaffiliates supports a broad set of techniques including HPLC, UPLC, UV/Vis spectroscopy, FTIR, ICP/ICP-MS, chiral chromatography, and 1D/2D NMR, enabling structure elucidation, impurity profiling and method flexibility. :contentReference[oaicite:3]{index=3}

Can Pharmaffiliates also provide method validation and method transfer services alongside method development?

Yes — method validation (to ensure suitability and compliance) and method transfer (to assess method reproducibility in a different lab) are part of the service portfolio. :contentReference[oaicite:4]{index=4}

Does Pharmaffiliates support stability-indicating and stability studies as part of their services?

Yes — Pharmaffiliates develops stability-indicating methods and performs stability studies (R&D preliminary, QC release, photostability, etc.), following international guidelines such as ICH Q1A-Q1F. :contentReference[oaicite:5]{index=5}

What documentation is provided after method development or validation?

Pharmaffiliates provides full documentation including method protocol, validation results, system suitability criteria and any relevant chromatograms or spectral data to support regulatory and QC requirements. :contentReference[oaicite:6]{index=6}

How do I request method-development services from Pharmaffiliates?

You can submit an enquiry via the contact/enquiry form on the Pharmaffiliates website, providing details about your API or drug product, intended application (e.g. assay, impurity profiling, stability), sample type and the scope of method required — a sales representative will respond with a proposal. :contentReference[oaicite:7]{index=7}

Method Development | Custom Synthesis Manufacturing

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Our advanced analytical tools help speed up the product development process. With well-planned method development, labs can make the most of their resources while ensuring each method aligns with the goals of every drug development stage.

Pharmaffiliates tests the analytical method extensively for

Specificity
Linearity
Accuracy
Precision
Ranges
Detection limit
Quantitation limit
Robustness

Analytical Method Development – FAQ

Yes — Pharmaffiliates aligns analytical method development with global regulatory expectations. Their validation protocols follow standards such as those described under ICH guidelines.

Pharmaffiliates develops a validation protocol (agreed and signed with the client) and carries out testing accordingly; the final deliverables include a full validation / method-development report — documenting method performance (specificity, accuracy, precision, limits, robustness, etc.)

Yes — Pharmaffiliates offers “Method Transfer” as part of their services, i.e. assessing the suitability of developed methods when implemented in another lab environment.

They have broad analytical capabilities including HPLC / UPLC, spectroscopic methods (e.g. UV, FTIR), chromatography, and can integrate with impurity profiling, stability- indicating testing, impurity/degradation product detection, etc.

Upon your request, Pharmaffiliates will review the chemical and regulatory requirements, define the scope and validation protocol with you, then perform analytical development and testing — timeline depends on sample type and complexity of method. (Exact lead-time provided after initial enquiry.)

Yes — their method development service supports stability-indicating methods, which are then used during stability studies, release testing, degradation / impurity profiling, etc.

Their analytical services are provided under compliance with recognized standards and operate within a full CRDMO framework — the labs are described as capable of supporting regulatory-compliant method development, validation and stability studies.

You typically need to provide chemical/physical information about the API or drug product (e.g. properties, intended dosage form or matrix, target analyte concentrations), your intended application (QC, stability, impurity profiling etc.), and regulatory context — Pharmaffiliates will then draft a protocol for your approval before starting. This ensures method suitability and compliance.