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Excipient Analysis & Characterization

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Delivered by Ofichem, building on Excipia’s characterization expertise, we offer quantitative excipient profiling and formulation insight to support generic development, comparability and troubleshooting.

What is excipient analysis?

Excipient analysis is the characterization of the non-API components in a formulation to understand what is present, how much is present, and how excipients contribute to product performance. Depending on the dosage form and project objective, this can include:

  • qualitative excipient identification
  • quantitative excipient profiling (Q1/Q2)
  • characterization of functional roles (e.g., binders, disintegrants, release modifiers)
  • support for physical equivalence considerations (Q3-support, where applicable)

Related Services

When clients use excipient analysis

Clients typically approach us for:

  • Generic development / BE & biowaiver strategies: Support Q1/Q2 alignment and, where needed, Q3-supporting characterization.
  • Comparability and change assessment: Understand composition and risks when materials, process, site, or suppliers change.
  • Troubleshooting and product improvement: Investigate underperformance, stability issues, variability, or manufacturability constraints.
  • Competitive or reference product understanding: Build evidence to guide development decisions.
  • Regulatory readiness: Provide robust evidence and interpretation for internal and external documentation.

Our services

Excipient identification & quantification (Q1/Q2)

We identify and quantify key excipients within complex finished dosage forms using fit-for-purpose analytical approaches supported by formulation expertise.

Typical outputs

  • list of identified excipients
  • quantitative composition (where feasible)
  • interpretation notes (functional role and criticality)
  • recommendations for follow-up testing

Formulation characterization (Q3-support where applicable)

When the objective requires more than composition alone, we provide additional characterization to support physical equivalence considerations and performance understanding.

Deformulation / reverse engineering

For complex products (e.g., coated systems, MR formulations, multi-functional excipients), a stepwise deformulation workflow can be the most efficient way to understand composition and structure.

Learn more about Reverse Engineering (Deformulation).

Typical deliverables

Depending on objective and sample availability:

  • excipient identification and functional interpretation
  • Q1/Q2 quantitative excipient profile (where feasible)
  • formulation characterization summary (Q3-support where applicable)
  • optional performance linkage (dissolution/disintegration/solubility insights)
  • recommended next development steps

Excipient knowledge resources

For practical background on specific excipients and their typical roles in formulations, see our knowledge resources:

Cellulose derivatives

Cellulose derivatives

(HPMC/Hypromellose, MCC, etc.)

Learn more
Polymer excipients

Polymer excipients

(PEG, PEO, PVP, etc.)

Learn more
Polysaccharides

Polysaccharides

(cellulose, starch, xanthan gum, etc.)

Learn more

How to start

To scope efficiently, we typically align on:

  • dosage form(s), strength(s), markets
  • objective (Q1/Q2, comparability, troubleshooting, competitive analysis)
  • sample availability (units and batches)
  • intended use (internal development vs regulatory support)
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