Pharmaceutical & Biotechnology Testing
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Pharmaceutical & Biotechnology Testing

ISO/IEC 17025 accredited testing for pharmaceutical manufacturers, biotechnology firms, compounding pharmacies, and outsourcing facilities. From potency and sterility to method validation and full release panels.

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Accredited to support:Sterile PreparationsNon-Sterile PreparationsPotency & AssaySterility TestingEndotoxin TestingStability & BUD StudiesElemental Impurities

Comprehensive Pharmaceutical & Biotech Programs

Full-scope testing across pharmaceutical, biotechnology, and compounding applications - from non-sterile preparations to 503B release programs and biologic characterization.

01

Pharmaceutical Release Testing

Identity, potency, purity, and impurity testing for pharmaceutical preparations, APIs, and compounded medications. Potency TestingIdentity TestingPurity TestingImpurity Profiling

⏱ TAT: 3-5 days

02

Non-Sterile Compounding - USP <795>

Analytical support for creams, ointments, capsules, troches, suspensions, and oral liquids. Potency TestingAPI IdentityContent UniformityResidual Solvents

⏱ TAT: 5-10 days

03

Hazardous Drug Testing - USP <800>

API verification, potency determination, impurity profiling, and analytical support for hazardous drug programs. API PotencyAPI IdentityImpurity Profiling

⏱ TAT: 5-7 days

04

Method Development & Validation

Development, verification, and validation of analytical methods for pharmaceutical, peptide, and compounded products. Method DevelopmentMethod ValidationTransfer Studies

⏱ TAT: Customized by project

05

Stability & Beyond-Use Date (BUD) Studies

Accelerated and real-time stability programs supporting product quality, shelf life, and beyond-use dating. Accelerated StabilityReal-Time StabilityProduct Characterization

⏱ TAT: Program-based (30-365 days)

Common Pharmaceutical Applications

We support pharmaceutical manufacturers, compounders, and product developers with method development, validation, characterization, and release testing across a wide range of active pharmaceutical ingredients (APIs) and finished formulations.

Peptide
Therapies

GLP-1 Agonists, Research Peptides & Biologic Drug Products

Hormone
Therapies

Testosterone, Progesterone, Estradiol & Related Compounds

Sterile
Preparations

Injectable, Ophthalmic & Inhalation Products

Compounded
Medications

Capsules, Troches, Creams, Suspensions & Oral Liquids

Custom
APIs

Method Development & Validation for Novel Compounds and Formulations

Standard Turnaround Times
Potency Testing3-5 Days
Identity Testing3-5 Days
Purity Testing3-5 Days
Residual Solvents3-5 Days
Heavy Metals5-7 Days
Stability StudiesProject-Based
Method DevelopmentProject-Based
Method ValidationProject-Based
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Questions About Your Requirements?

Our team includes experienced regulatory specialists and scientific professionals who can help identify the appropriate testing approach for your product, formulation, and quality requirements.

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