Pharmaceutical Excipient Analysis Service

MtoZ Biolabs provides Pharmaceutical Excipient Analysis Service to help clients evaluate the quality, safety, and functionality of excipients used in drug formulations. Derived from biological, mineral, or synthetic sources, these materials influence solubility, compressibility, dissolution rate, and overall bioavailability. With advanced analytical platforms and standardized testing workflows, MtoZ Biolabs conducts comprehensive assessments of excipient composition, purity, and performance, supporting both research and large-scale manufacturing in compliance with international quality expectations.

 

What are Pharmaceutical Excipients?

Pharmaceutical excipients are non-active ingredients incorporated into drug formulations to facilitate manufacturing, enhance stability, and optimize drug delivery. They act as binders, disintegrants, fillers, lubricants, stabilizers, emulsifiers, and coating agents, ensuring that active pharmaceutical ingredients (APIs) maintain their intended efficacy throughout a product’s shelf life.

Excipients may originate from plant polysaccharides, cellulose derivatives, mineral materials, or synthetic polymers. They are typically classified according to their function within dosage forms, including:

• Binders that maintain tablet cohesion
• Disintegrants that promote tablet breakdown
• Fillers or diluents that ensure uniformity and volume
• Lubricants and glidants that improve processing flow
• Stabilizers and preservatives that extend product stability
• Coating agents that enhance protection and appearance

 



Figure 1. Types of Pharmaceutical Excipients

 

Although excipients are often described as inert, they can interact with APIs or environmental conditions, affecting product safety and efficacy. Therefore, comprehensive analytical characterization of excipients is critical to confirm their identity, purity, and suitability for pharmaceutical use.

 

Services at MtoZ Biolabs

MtoZ Biolabs offers a broad range of Pharmaceutical Excipient Analysis Services covering both natural and synthetic excipients used in modern drug formulations. The following table lists representative excipients analyzed in our laboratory.

 

Ethylcellulose	Sucralose	Wheat Starch	Potato Starch	Tapioca Starch
Maize Starch	Compressible Sugar	Soluble Starch	Methylcellulose	Guar Gum
Tragacanth	Croscarmellose Sodium	Cellacefate	Maltodextrin	Hyaluronan
Alpha Cyclodextrin	Beta Cyclodextrin	Gamma Cyclodextrin	Arabino Galactan	Acacia
Pectin	Powdered Cellulose	Alginic Acid	Sodium Alginate	Pregelatinized Hydroxypropyl Starch
Pregelatinized Starch	Xanthan Gum	Steviol Glycoside	Hydroxyethyl Cellulose	Hypromellose
Hydroxypropyl Cellulose	Hydroxypropyl Betadex	Vacant Hydroxypropyl Starch Capsule	Dextrate	Agar
Calcium Saccharate	Caramel	Pullulan	Microcrystalline Cellulose	Carboxymethylcellulose Calcium
Carboxymethylcellulose Sodium	Sodium Starch Glycolate	Polydextrose	Sucrose Octaacetate	Sugar Sphere
Sucrose Stearate	Pea Starch	Cellulose Acetate	Hypromellose Acetate Succinate	Dextrin
Sodium Starch Phosphate	Gellan	Low-substituted Hydroxypropyl Cellulose

 

Our Main Analytical Capabilities:

To ensure product consistency and reliability, MtoZ Biolabs performs comprehensive excipient testing using advanced analytical instrumentation and validated methodologies.

1. Composition and Structural Analysis

We use analytical techniques such as HPLC, GC, IC, FTIR, UV/VIS, and NMR to confirm identity, detect residual solvents, and verify molecular integrity and composition.

 

2. Physicochemical Characterization

We measure key properties such as moisture content, solubility, viscosity, particle size, and pH to assess suitability for various dosage forms. Gel permeation chromatography (GPC) is used to determine molecular weight distribution for polymer-based excipients.

 

3. Purity and Impurity Profiling

Impurities and trace elements are analyzed using ICP-MS, AAS, and GFAA. Testing procedures are aligned with recognized analytical standards to ensure accuracy and reproducibility.

 

4. Functional Performance Evaluation

Functional assays examine binding strength, disintegration behavior, emulsification capacity, and thickening performance to assess excipient contribution to overall formulation stability.

 

5. Compatibility, Stability, and Safety Testing

Compatibility between excipients and APIs is evaluated using Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), and chromatographic profiling. Microbial and elemental impurity testing supports safety and quality assurance.

 

Sample Submission Suggestions

• Sample Type: Powdered, granulated, or liquid excipients
• Minimum Quantity: 1 g or 1 mL
• Storage Conditions: Keep sealed, dry, and away from light
• Additional Information: Include excipient name, lot number, and intended pharmaceutical application

Detailed submission guidelines are available upon request.

 

Why Choose MtoZ Biolabs?

✅ Comprehensive Coverage: From molecular identification to performance evaluation.

✅ Expertise: Experienced chemists and formulation scientists ensure precise data interpretation.

✅ Reliable Quality: All procedures follow validated protocols with reproducible results.

✅ Flexible Solutions: Customized testing approaches tailored to project-specific needs.

✅ One-Time-Charge: Our pricing is transparent, no hidden fees or additional costs.

 

Pharmaceutical Excipient Analysis Service at MtoZ Biolabs delivers accurate, reproducible, and regulatory-compliant testing to ensure the quality and consistency of your pharmaceutical formulations. Our state-of-the-art instrumentation and experienced scientific team provide comprehensive evaluation of excipient identity, purity, and performance to support confident formulation development.

 

MtoZ Biolabs is dedicated to helping clients achieve the highest standards in product quality and safety. To discuss your project needs or request a customized testing plan, contact our team today and discover how our Pharmaceutical Excipient Analysis Service can strengthen your formulation process.

 

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