Pharmaceutical Testing & Analytical Method Services

From Analytical Precision to Product Confidence

Supporting pharmaceuticals, natural products, traditional medicines, and health supplements with chemical and microbiological testing, stability studies, and analytical method development, verification, and validation.

Pharmaceutical Chemical Testing

Analytical Precision for Pharmaceutical Quality.

Our pharmaceutical chemical testing services support quality control, product development and regulatory compliance for pharmaceutical products, natural products and health supplements. Our analytical capabilities cover pharmaceutical impurities, residual solvents, elemental impurities, assay, related substances, and physical and pharmacopoeial testing using advanced chromatographic and spectrometric techniques.

Pharmaceutical Chemical Testing Capabilities

Nitrosamines, Genotoxic & Mutagenic Impurities

Trace-level analysis of nitrosamine impurities, including NDMA, NDEA and others; nitrosamine drug substance-related impurities (NDSRIs); azido impurities, including AZBT; and other product-specific impurities. Testing supports impurity control strategies, risk assessment, product investigations and applicable regulatory requirements.

Residual Solvents

Residual solvent testing for pharmaceutical products, raw materials, excipients and natural products using headspace GC-FID for solvent classes specified in USP (467), as well as product-specific solvents and acceptance criteria.

Elemental Impurities & Metals

Elemental impurity and metals testing using microwave-assisted digestion followed by ICP-MS or ICP-OES. Services support risk-based elemental impurity assessment and applicable requirements, including ICH Q3D and USP (232)/(233).

Assay, Related Substances & Chemical Quality

Quantitative and qualitative testing of active pharmaceutical ingredients, excipients, raw materials, finished dosage forms, OTC products, medicated oils and ointments. Capabilities include assay, related substances, degradation products and other chemical quality attributes using HPLC/UPLC with PDA, ELSD or RID, GC-FID, GC-MS and LC-MS/MS, as appropriate to the analyte and matrix.

Physical & Pharmacopoeial Testing

Physical and pharmacopoeial testing to evaluate dosage-form performance and product quality in accordance with applicable compendial or product-specific requirements. Examples include uniformity of weight, disintegration and dissolution testing.

Looking for a specific chemical test?

Share your product type, target analyte, specification, and relevant compendial or regulatory reference. Our technical team can assess feasibility and recommend an appropriate analytical approach.

Pharmaceutical Microbiological Training

Quality Goes Beyond What You Can See

Our pharmaceutical microbiological testing services support the microbial quality and safety of pharmaceutical products, natural products, and health supplements through microbial enumeration and specified microorganism testing in accordance with applicable pharmacopoeial requirements and Malaysia’s NPRA Drug Registration Guidance Document (DRGD).

Pharmaceutical Microbiological Testing Capabilities

Microbial Enumeration Tests

Quantitative assessment of microbial load in pharmaceutical products, natural products, and health supplements to evaluate microbiological quality and compliance with applicable pharmacopoeial and product-specific limits.

Testing includes

Tests for Specified Microorganisms

Detection of specified microorganisms in pharmaceutical products, natural products, and health supplements to support product safety and compliance with applicable pharmacopoeial and regulatory microbiological requirements.

Testing includes

Not sure which microbiological tests apply to your product?

Our technical team can help determine the appropriate microbial testing requirements based on your product type, specification, and applicable pharmacopoeial or regulatory requirements.

Analytical Method Services

Built on Method. Proven by Performance.

Fit-for-purpose analytical method services for pharmaceutical products, natural products, and health supplements, covering analytical method development, method verification, and method validation for compendial and product-specific procedures.

Analytical Method Development, Verification & Validation

Analytical Method Development

Development of fit-for-purpose analytical methods where an established compendial or suitable existing method is unavailable or requires adaptation for a specific product, analyte, or matrix.

Method Verification

Verification of compendial or established analytical methods to demonstrate their suitability for the intended product, analyte, matrix, and laboratory conditions.

Method Validation

Validation of analytical methods to demonstrate that the method is suitable and reliable for its intended analytical purpose.

Fit-for-Purpose Study Design

Study design is tailored to the method's intended use and may include specificity, linearity, accuracy, precision, range, robustness, solution stability, and filter compatibility, where applicable.

Pharmaceutical Stability & Shelf Life Study

Quality That Stands the Test of Time.

Our pharmaceutical stability and shelf life study services evaluate the chemical, physical, and microbiological quality of pharmaceutical products, natural products, and health supplements under defined storage conditions and testing intervals to support stability assessment, shelf life determination, and applicable regulatory requirements.

Pharmaceutical Stability Study Services

Real-Time Stability Study

Long-term storage and scheduled testing under defined conditions to monitor product quality over time and generate stability data supporting the proposed shelf life and storage requirements.

Accelerated Stability Study

Controlled storage in stability chambers under accelerated conditions, with scheduled testing to evaluate changes in critical quality attributes and generate supporting stability data within a defined study period.

Client-Managed Stability Samples

Testing of stability samples stored and submitted by clients at defined time points, based on the agreed analytical scope, product specification, or stability study protocol.

Planning a stability study?

Our technical team can work with you to define the study scope, storage conditions, testing intervals, and analytical requirements based on your product and stability objectives.

Why Choose Allied Chemists for Pharmaceutical Testing?

NPRA Recognised Laboratory

Recognised by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) to support pharmaceutical and natural product testing within our approved laboratory scope.

Pharmacopoeial & Regulatory Expertise

Testing supported by applicable pharmacopoeial and regulatory requirements, including USP, BP, Ph. Eur., ICH and NPRA references, with technical expertise to address product-specific analytical requirements.

Laboratory Management System (LMS)

Secure customer portal with live result access, sample progress tracking and raw data visibility, providing greater transparency, traceability and data integrity throughout the testing process.